PDA

View Full Version : Why I decided to brace my daughter with the SpineCor



concerned dad
01-07-2009, 04:16 PM
EDIT
I see this thread has received over 6000 views.
I feel I need to edit this post and say up here in the front that we have decided AGAINST the SpineCor after trying it for 2 months.
Not ready to get into details, but in the interest of completeness I wanted to add this to the post.


OK, this may be a long post. It is a continuation of a couple of threads
Here (http://www.scoliosis.org/forum/showthread.php?t=8136) and Here (http://www.scoliosis.org/forum/showthread.php?t=8153) where my understanding and thinking on the whole topic of bracing has evolved.

Although I use the singular "I", a more accurate title might be "Why WE decided to brace our daughter with SpineCor" as it was a mutual decision between my wife, my daughter and myself. But since "I" am the one who is writing this, I am writing in that voice.

On the other thread, forum participants asked some good questions regarding the SpineCor. While thinking about the response I realized it is basically a summary of “Why I decided to brace my daughter with the SpineCor”. I can totally respect and understand a parent looking at the same information and coming to a completely different decision. Each child is different, every family is unique, and we all must bear the personal responsibility for our decisions. I am putting this in a separate post in case someone out there is in the same situation as I was in 6 weeks ago, it may be easier to find. Perhaps this can be used as a STARTING point for their own personal research. Everything you read on this forum is just a personal opinion, and this is no different. I suggest anyone using this site to continually read the disclaimer on the introductory page. And then read it again.

If you are going to try to learn about the issue and controversy about bracing I strongly suggest that you gain access to the medical literature. PubMed is a good starting point but they only provide the abstracts. There is much to learn by reading the full papers. The discussions about bracing trials are more statistical than medical. Most large universities with a medical school have the journals. Anyone (not just the med students) affiliated with the university has access to the libraries. Most libraries are also open to the local communities. Once you have access you will find most of the journals are available electronically. I also suggest you read the letters to the editors. Often, controversial studies are further discussed and debated in the “letters” section of the journals several months after the original paper is published.

My dear 14 year old daughter was diagnosed with AIS 6 weeks ago at her yearly well child visit. We quickly met with an orthopedic surgeon who said the curve was 38 degrees and told us she should be braced. She is Risser 0 which means she likely has not finished growing although she is almost 1 year post menarche. He recommended the Boston Brace. I have learned that with her low Risser and high curve angle, she has a higher likelihood of ultimately progressing to surgery. EDIT - her skeletal age appears to be older than her Risser suggests - see discussion below here (http://www.scoliosis.org/forum/showpost.php?p=70553).

OK, so what have I learned about bracing? It can basically be summed up as follows:
There is no clear consensus.
On the other threads you can read discussions about some of the pro and con arguments regarding brace efficacy. (there we are talking about bracing in general, not one brace vs another.) It is my personal opinion that bracing is beneficial in many children. Many people, far more knowledgeable than I, share this view. Although I acknowledge that a valid case has been made by some researchers that, basically, the jury is still out. There is a large trial underway now where they are randomly assigning children to either be braced or unbraced and the study will follow and compare the progression of their AIS. It will probably be several years before we know the results.

Now, if you’re still with me, you’ll see that we have decided to have our daughter braced. If her curve were significantly different (one way or the other) or if she were in a different point of her growth, we may have come to a different decision. The next decision for us was which brace to use.

Anyone who googles “scoliosis” will be bombarded by advertisements for SpineCor providers. I found this troubling. It seems very commercial and drove home the “for profit” aspect of a medical device. If we view it in the context of Sally Field hawking Boniva and Bob Dole with Viagra I suppose it is more understandable. Anyway, I got over it, but it caused me to be more even more suspect of the literature. It was going to take more to convince me than just personal testimonies, the bar was raised.

I think SpineCor made a bad business decision marketing the brace largely through Chiropractors here in the US. Most successful orthopedic doctors probably don't have the time to devote to the training necessary to fit the SpineCor (although a few hospitals in the states are using it) The orthopods leave much of the Boston brace fitting to orthotisists. If an orthopedic doctor wanted to fit a patient with a SpineCor he would have to rely on one of the several trained chiro’s to help. Many orthopods don’t have high respect for chiropractors. The chiro’s DO often have access to an x-ray machine and that is necessary. And I would guess that the vast majority of chiropractors are caring legitimate professionals who, if trained, have the skills and knowledge to use the SpineCor brace.

It is unfortunate that most of the literature on the SpineCor is written by the doctors who developed it. There may be bias, I don't see how there can NOT be bias. But, unless there is actual malfeasance, the data in the published literature on the SpineCor looks pretty compelling. I am not going to link the papers here, but they are not that hard to find.

There is a common theme on the bracing forum where one gets the impression that the hard braces are very difficult to wear and adjust to. The technical literature on bracing studies notes that compliance is a real issue. I get the impression after reading posts here that for children wearing the SpineCor, it is not that difficult to tolerate.

We are going with the SpineCor. If it fails to stop the curve progression I can at least find solace in the thought that perhaps NO brace would have stopped the curve and I didn't subject her to years of hard brace treatment. And, some people, not all, maybe not the majority, but some, have experienced pretty remarkable results.

Which brings me to addressing the following comments. Sharon on the other thread asks?

Is there any evidence to date in hand that Spinecor can actually permanently reduce a curve? Is there any evidence that Spinecor holds the curve such that growth corrects the curve like has been seen with VBS?

If so, I think it is the first brace to ever accomplish that. It would be huge. To date, only surgery, fusion and non-fusion, can reduce a curve permanently as far as I know. Someone correct me if I'm wrong.

and

Do they have JIS patients yet who were braced through growth spurts and have reached skeletal maturity and have a stable Cobb angle less than the highest measured at any point?

If they do, it will be huge.

Well, Yes, there is some evidence that some patients have had permanent reductions. Bare with me while I walk you through this.
Montgomery (in 1990 Journal of Pediatric Orthopedics) makes the case that 2 years post bracing is sufficient for predicting progression. He says “A follow-up of 2 years was sufficient to predict with great accuracy (97%) all incidences of failure.” Perhaps this is why the new SRS study guidelines call for the inclusion of data 2 years post bracing.

What do we know about the boston brace 2 years post bracing? Curves revert to prebrace amplitudes. That’s not bad, in fact that’s great if it means the curve is stopped and surgery is avoided. It is considered a resounding success.

But what about the data for the SpineCor? A paper published in 2007 (Colliard, Journal of Pediatric Orthopedics) complied with the new SRS guidelines for bracing studies. (And, correct me if I am wrong, I think this is the first Brace paper that came out presenting data in accordance with the new SRS guidelines). They presented their data for SpineCor patients 2 years after bracing ceased. They report: “Comparing the end of bracing Cobb angle to the one at 2 years after bracing, our study reveals that the follow-up of orthopaedic treatment was a success in 95.7% of the patients, with a mean correction angle of 8.6 +/- 1.7 degrees.“.

Dr. Colliard in an earlier paper showed a graph (attached). This was from an earlier study with a smaller group of patients. But it shows similar results. I added the red horizontal line marking before brace average curve. Compare it with the 2 year post brace curve amplitude. Pretty impressive.

Some patients had an 8.6 degree correction maintained 2 years after removal of the brace (ie permanent). That is indeed, as Sharon says, “huge” and that is “Why I decided to brace my daughter with the SpineCor”.

concerned dad
01-07-2009, 05:00 PM
and I want to add/bump the post below which I found helpful.
I ran across the old post during my searching through this forum. I thought it was useful and I am reposting it here. (I understand that his daughters curve and age was similar to my own child, and he chose the same path (SpineCor) as us, and although initially promising, his daughter’s curve continued to the point where surgery was required.)
Too bad he's not still around. I'd like to have a chat with him.


9/16/05
(Note: I know there are strong opinions on this site about different treatments, etc. This entry is for parents and offers my personal analytical insight as a Dad on what’s I’ve “taken in over the last 3 weeks. They reflect my opinions and are offered only for insight.)

Tomorrow will complete our first full week in the Spinecor brace and Nikki is wearing it 20 hours per day, including her dance classes. (She will take it off during performances.) The very first day, she had a bathroom accident as she was not used to the straps. To avoid future “bathroom function” issues my wife suggested she wear only the body suit without underwear (we have four body suits and wash them frequently.) No further accidents. Compliance is VERY good and despite her disliking it initially, Nikki has not only accepted it but has named it ROXY. Nicole names all things she likes including her stuffed animals, cell phone, dance bag, etc. After inquiring as to what caused the change, she told me she “loves the brace because she wants it to help her spine and hates that hard brace (boston)”. This was particularly interesting to my wife and I as it occurred in the backdrop of yesterday.

Yesterday, we went to Shriner’s in Philly (I am a Mason and will sponsor anyone needing it) to get a “second opinion”. The doctor had a “great personality” and he was simultaneously, was able to encourage us as parents while not encouraging the use of the Spinecor. He confirmed the previous ortho’s diagnosis but used the measurements of our chiro in NYC to say she has a 37 degree curvature. He believed she is a candidate for surgery if the curve progresses on our next update visit in January. If it does progress, he recommended to stop the bracing, have Nikki enjoy life and prepare for surgery after her growth stops (in 1 to 1.5 years). That will be our last resort as we will go to Germany for the Shroth Method. He felt the lack of peer review on the Spinecor is its biggest weakness and from his experience, “10% of all patients had their curves realigned, 80% had their curves halted (but did not comment on whether or not they had surgery) and 10% got worse”. Those of you in business may recognize this as a Pareto Analysis. On the way home, we discussed with Nikki the possibility of going in the hard brace in January if the curve does not stabilize and the possibility of surgery. She has accepted surgery as a possible outcome (perhaps better than her Dad!) and indicated she would rather have surgery than go in the hard brace. (This resiliency made my wife and I feel a whole lot better than we did 3 weeks ago when we saw how distraught she was at the mention of surgery.)

Here’s are the “facts” I’ve come across.
1. The medical field does not know the cause of idiopathic scoliosis.
2. “Conventional treatment” is simple: hard brace at 25 degrees+ and
corrective surgery if the curve progresses beyond 40-50 degrees. The
occurrence of scoliosis is 8x more prevalent in girls than boys.
3. The treatment theory for hard bracing immobilizes the spine through
inactivity.
4. A 20% reduction of lung capacity and overall muscle atrophy in the back
is common during bracing.
5. Many “innovations” of the hard brace exist including the boston,
milwaukee, wilmington which are actually technological updates of the
braces that have existed since the 1800’s. Bracing is about $3000 and
covered by insurance.
6. Surgery is the only “acceptable” medical method for ultimate spine
correction. Some people have experienced the progression of their
curves halted or even realigned. Surgery costs $100,000 to $150,000.
In the US, of every 1,000 children, 3 to 5 develop spinal curves that are
considered large enough to need treatment. (See NIAMS (National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a
part of the National Institutes of Health (NIH)). This means 42,000 to
70,000 kids are diagnosed with treatable scoliosis. (Surgery for all
diagnosed represents a potential market of $10.5 billion per year)
7. Some people have experienced the progression of their curves halted or
even realigned. The overwhelming majority of these occurrences have
been from continued activity (linkage?) which seems to counter the
rationale behind hard bracing.
8. The overwhelming majority of these occurrences have been with
continued activity and not through bracing, which overwhelming seems to
lead to surgery. (Even the doctor at Shriner’s said many orthos don’t
believe in bracing and go right to surgery.)
9. The medical profession and orthotists appear monolithically unified into
discouraging anything but “conventional treatment” for scoliosis.
10. Legally, doctors cannot prescribe surgery at less than 40 degrees.

My opinions follow. When my wife, daughter and I found out Nikki had scoliosis with a 40 degree curve, we were devastated like most of you, I am sure. As parents were looking for hope to avoid surgery. Our research led us to the Spinecor brace whose only “distribution channel” appears to be with chiropractors. The Spinecor costs $6000 and is not entirely covered by insurance. The suspicious business person considered two questions: “Why are orthos and othotists so unified against “conventional treatment” and “Is the Spinecor practictioner capitalizing on our desire for hope to avoid surgery?” I call this the gimmick factor. After much research and angst on what to do, we decided the Spinecor brace is more fitting to our daughter’s lifestyle and went against conventional treatment. The treatment theory for Spinecor is for continued activity while emphasizing different muscles. We believe the treatment (without chiropractic adjustments) offers us the best chance for halting the progression of the curve and maintaining my daughter’s quality of life but will consider hard bracing and other treatments, including surgery as a last option.

Is it possible a $6000 treatment can seriously reduce the worry and complications associated with a $150,000 surgery. The verdict is out. If it does, as a business man, it will be the best investment I will ever make. What implications does that have on the “scoliosis market”?

Ed

Haleysmom
01-07-2009, 05:03 PM
Thank you for the great summary. I have been following the arguments on the other threads and that itself gets frustrating as we all have to make decisions regarding treatment. There is no one clear consise answer for treatment. Decisions we make as parents should not be bashed by others - we are all trying to do our best for kids!

Good luck with Spinecor....we go in for a check on Friday so its hot on my mind today.

christine2
01-07-2009, 05:11 PM
Haleysmom

Good luck Friday, I will be thinking of you!!

That was a good post, wasn't it.

Pooka1
01-07-2009, 08:42 PM
I like your thought process. If there was a post of the month contest, I would nominate your post. :)

I finally found the original 2007 Colliard et al. paper you reference on line courtesy of our friendly neighborhood Spinecor types...

Colliard et al., 2007 (http://www.scoliosisspecialists.com/JPOSpineCorPaper.pdf)

I'd like to know what you think of the design.

Pooka1
01-07-2009, 09:18 PM
Decisions we make as parents should not be bashed by others - we are all trying to do our best for kids!

I agree that decisions shouldn't be bashed per se. But counterfactual claims need to be corrected for the good of everyone. Quackwatch is there for a reason. A very good reason.

concerned dad
01-07-2009, 09:30 PM
Thanks for the kind words



I'd like to know what you think of the design.

I'm glad you asked. I'll edit this post tomorrow AM with some comments

BellasMom
01-07-2009, 09:44 PM
Concerned Dad!

Very impressive and I am glad to read about your research - makes me think that I did something right too ;)

Good luck with your appointment!

emarismom
01-08-2009, 07:10 AM
Concerned Dad,

It is funny that you decided to repost the 9/16/05 post. As I made the same decision you made, to brace my daughter 8 at the time, 10 now. But that particular post has actually haunted me for years, as it has made me question the true "motives" of all of the doctors/chiros my daughter has seen. I remember reading it years back and being stunned by it's implications.

While the jury is still out on the true effectiveness of the Spinecor. I agree that this was the best option that I had two years ago, and still to this day.
While my daughter is JIS and VBS is available, do to other health issues I really didn't give VBS as much attention as maybe I should have. But I wouldn't change my decision. The Spinecor brace has been very easy to wear in comparison to a Boston. We have a friend whose daughter, same age as mine wears a Boston, and compliance IS a HUGE issue.

Finally, I would also agree that marketing the Spinecor through chiropractors was a bad business decision, it seems it may have been the only option available to the Spinecor Corp. if the hoped to sell in the US. As you said stated the orthopedic doctors were unwilling to use it, whatever the reasons.

BellasMom
01-08-2009, 09:38 AM
My suspicion on the subject would be that chiros do the fitting themselves, doctors - trust their technicians.

If technicians are not properly trained, doctors do not see good results and abandon SpineCor. Chiros rely on themselves, they do both - fit and see results.

concerned dad
01-08-2009, 10:47 AM
I'd like to know what you think of the design.

To discuss your question really requires us to go back to the SRS guidelines paper (Spine 2005). We briefly touched on this on the other thread and I had intended to throw my 2 cents in. You correctly pointed out to me that the usefulness of the previous bracing papers was questionable. We differed (I think) on the issue of control groups and you suggested that the new SRS guidelines called for control groups (either implicitly or explicitly). I would maintain that the SRS guidelines do not call for control groups. Rather, they recognize the challenges and limitations of drawing conclusions from studies done without control groups and attempted to establish some guidelines by which future studies could be compared. They say:

The purposes of our study are to define consistent parameters for inclusion criteria for orthotic treatment of patients with AIS and to define consistent parameters to assess the effectiveness (outcomes) of treatment. These parameters could then serve as guidelines for all future AIS bracing studies to make comparisons among studies more valid and reliable.

So, the usefulness of the SRS guidelines will only be realized when researchers start reporting their results consistent with the guidelines. This is exactly what Dr. Coillard did in her paper. What I would really like to know is: has anyone else done this yet? If so, how did their results compare with the SpineCor using the same recommended SRS reporting guidelines?

In terms of what I think of the design? Well, I think the design was based on the SRS guidelines. Dr. Coillard addressed every point in her paper that was called for under the SRS guidelines.

The one critique I have, and it is not with Dr. Coillards paper, but rather with the guidelines, is related to the quote I made in the top post.

“Comparing the end of bracing Cobb angle to the one at 2 years after bracing, our study reveals that the follow-up of orthopaedic treatment was a success in 95.7% of the patients, with a mean correction angle of 8.6 +/- 1.7 degrees.“.

It took me a while to understand this. It sounded almost like an advertisement, too good to be true, 95.7%? However, reading the guidelines I see that they specifically call for the reporting of that number. The SRS guidelines call for:

A minimum 2-year follow-up beyond skeletal maturity for each patient who was “successfully” treated with a brace to determine the percentage of patients who subsequently required or had surgery recommended.

So, it is not the percentage of patients successfully braced, but rather the percentage of patients initially considered to HAVE BEEN successfully braced and still did not go on to surgery within 2 years. So, it is not really my critique, it just demonstrates how dense I can be. It took me a while to wrap my head around this particular parameter. I am sure the intended audience of the journal is much smarter than me….. I am just a “Concerned Dad” trying, with the help of you folks, to wade through all this and make the right decisions for someone I love with all my heart.

concerned dad
01-08-2009, 11:38 AM
And, what the heck, I have something else to add.
The intent of this thread was to perhaps help someone down the line who may be in a similar situation. Again, a starting point, from one parents perspective.
I think it appropriate to mention that from time to time on this forum I have seen what appears to me, to be shills or plants. I don’t know if anyone can prove it in all cases, but I have seen some really suspect posts.
When I first starting reading this forum it wasn’t at all apparent to me that this was going on. But, if you look through here long enough you will see what I mean.
The “shills” usually promote a treatment, often with a specific practitioner and not infrequently, for SpineCor. Heck, the first post I linked above started as a discussion about someone who believes her blog was spammed by a SpineCor provider. I guess I am just mentioning this to caution a newbie. (not to be confused with forum posters who share their Doctors name in their Signature - I'm talking about posters, usually with just one or two posts, who come on here and then leave right away)

And, it occurred to me that perhaps, as this is, in essence, a pro SpineCor post, that I may be suspect too. I prefer to remain anonymous as many posters here do. But I would be happy to demonstrate to a moderator that I am indeed nothing more than a concerned dad.

BellasMom
01-08-2009, 11:53 AM
Oh, come on ... you definitely don't look like a spammer or a bot or a promoter of any kind

For once, you spend way too much time doing the research and answering questions

I wish there were more people like you here for my own benefit - I am not that good at reading all the scientific papers, but your abstracts are very helpful

Again, good luck with your appointment and let us know the measurements afterwards

Pooka1
01-08-2009, 07:33 PM
(snip)
In terms of what I think of the design? Well, I think the design was based on the SRS guidelines. Dr. Coillard addressed every point in her paper that was called for under the SRS guidelines.

I think these would be correctly referred to as criteria for comparing different braces (as mentioned in the article). What I think they are assuming is that controlled studies are needed to say anything about bracing efficacy over and above watching and waiting. Why do I think the SRS assumes a controlled study is necessary for this purpose? Because they say so...

In 1985, the Scoliosis Research Society (SRS) initiated a study to investigate the effectiveness of bracing as a treatment for scoliosis. Many previous studies of full time bracing showed that braces stop about 80% of curves. All of these studies, however, were "uncontrolled" which means there were no simultaneous groups of untreated, unbraced patients for comparison. Therefore, there was some doubt that brace treatment of scoliosis was effective, and concern that bracing may be no different than "natural history" or what happens when no treatment is undertaken.

I repeat my concern... I don't see how you know what the bracing is doing without a control group. In this paper, they are claiming victory mainly with smaller curves that are known not to progress. But because the patients were braced they mark it in the "successful bracing" column. For all we know, none of those patients with smaller curves or even some with larger curves would have progressed anyway. Nothing in this study rules out that possibility. I continue to question the peer-review and editing of these journals.


The one critique I have, and it is not with Dr. Coillards paper, but rather with the guidelines, is related to the quote I made in the top post.

“Comparing the end of bracing Cobb angle to the one at 2 years after bracing, our study reveals that the follow-up of orthopaedic treatment was a success in 95.7% of the patients, with a mean correction angle of 8.6 +/- 1.7 degrees.“.

It took me a while to understand this. It sounded almost like an advertisement, too good to be true, 95.7%? However, reading the guidelines I see that they specifically call for the reporting of that number. The SRS guidelines call for:

A minimum 2-year follow-up beyond skeletal maturity for each patient who was “successfully” treated with a brace to determine the percentage of patients who subsequently required or had surgery recommended.

So, it is not the percentage of patients successfully braced, but rather the percentage of patients initially considered to HAVE BEEN successfully braced and still had to go on to surgery within 2 years. So, it is not really my critique, it just demonstrates how dense I can be. It took me a while to wrap my head around this particular parameter. I am sure the intended audience of the journal is much smarter than me….. I am just a “Concerned Dad” trying, with the help of you folks, to wade through all this and make the right decisions for someone I love with all my heart.

No actually I think that statistic is quite unclear and you were right to be confused. I am still confused as to what exactly it means.

Here are some questions I have about that statistic:

1. It's important to realize that only 47 of the 170 patients (~28%) in the study were followed up at 2 years. Why so few? Were these predominantly the ones who started with smaller curves that wouldn't have progressed anyway?

2. I don't want to be incendiary but this is an overt case of data selection EVEN IF only 47 patients were available to them. Ask yourself what is the lower limit of percent of total patients where it wouldn't matter how many were stable? For me, ~28% is too low to draw any conclusions given that we know smaller curves will not progress despite no treatment and that we know several treated kids went on to have fusion.

3. What exactly do they mean by weaning point? Is that at the start of the weaning or at the end? Elsewhere they say the comparison is at the end of bracing. I take that to mean before the weaning period. How long is the weaning period? Is it 2 years or some substantial portion of that time? Why is a weaning time necessary if the brace is working? I think what needs to be compared CLEARLY is the end of the main bracing (allowing a week solid out of brace) and two years after that point (assuming the weaning period isn't more than a few months). The two year period that the Montgomery paper talks about almost certainly doesn't involve any weaning period which is really a continuation of bracing.

Other questions I had about this paper include:

1. no control group (as mentioned above)

2. extremely liberal indication for surgery of >60*! Why not 80*? Or 100* This is ridiculous as most surgeons pull the trigger at far lower Cobb angles. How would have the stats changed if they adopted a more realistic point like 45* or 50*. We scheduled surgery when my daughter was in the high 40s* (albeit with a known high rate of curvature). This is further proof that surgery recommendation or having surgery is an extremely non-robust (i.e., worthless) criteria.

3. 101 of the 170 patients were reported to be stable after bracing. But when was that determined? Was it determined within 5 minutes of taking the brace off for the last time? Was stability determined before, during, or after the weaning period?

4. It is important to emphasize that these results at best strictly only apply for the group of patients that meet all criteria. 144 kids being treated didn't meet the criteria. It would be interesting to know anecdotally how they failed to meet and generally how this group is doing.

concerned dad
01-08-2009, 08:27 PM
Wow, you're really going to hold my feet over the coals on this. :eek:
I like it. :cool:
Good points that deserve to be hashed out.
I'm going to need some time though
:D
gotta keep in mind that 10% Utah thing (http://www.scoliosis.org/forum/showpost.php?p=69096);)

Pooka1
01-08-2009, 08:34 PM
(snip)
gotta keep in mind that 10% Utah thing;)

Titanium Ed lives sort of near Utah (I had to check a map first though). I'm hoping he can help us out with understanding that statistic. :D

concerned dad
01-09-2009, 06:24 PM
I do appreciate your thoughtful comments. I was just kidding about the holding my feet to the coals stuff. It is important to me to convince myself that I am not “drinking the Kool-Aid” when it comes to the SpineCor. There certainly is a risk that a parent like myself, after facing the new news about the diagnosis, will be more susceptible to embracing miracle cures because that is what we want. I don’t think that is the case here. Your comments continually point me in new directions to evaluate and attempt to understand the scientific literature on the subject.

My comments on your last post are in red below.

For the benefit of anyone following this, we are discussing two papers. The first is written by Coillard in 2007 and published in the Journal of Pediatric Orthopedics. Coillard was part of the team that developed the SpineCor. I’m referring to this above and below as “the Coillard paper” and Sharon linked to the full text in a post above.
Effectiveness of the SpineCor Brace Based on the New Standardized Criteria Proposed by the Scoliosis Research Society for Adolescent Idiopathic Scoliosis
The second is written by the SRS Committee on Bracing and Nonoperative Management And published in the Journal Spine in 2005. I’m referring to this above as the “new SRS Guidelines” paper and below as the “new SRS paper”.
Standardization of Criteria for Adolescent Idiopathic Scoliosis Brace Studies
There are other papers that come into this discussion below and I’ll try to keep everything straight.

Now, Sharon, I don’t mean to offend you on this first point. But I would bet my last dollar that you haven’t read (at least recently) the “new SRS paper” in its entirety. If you had, I don’t think you would have made several of your arguments as the SRS paper is pretty clear on many of the issues under debate.

Quote:
Originally Posted by concerned dad
(snip)
In terms of what I think of the design? Well, I think the design was based on the SRS guidelines. Dr. Coillard addressed every point in her paper that was called for under the SRS guidelines.

I think these would be correctly referred to as criteria for comparing different braces

Criteria or Guidelines? I think it is semantics. But the “new SRS paper” says (emphasis added is mine)

The purposes of our study are to define consistent parameters for inclusion criteria for orthotic treatment of patients with AIS and to define consistent parameters to assess the effectiveness (outcomes) of treatment. These parameters could then serve as guidelines for all future AIS bracing studies to make comparisons among studies more valid and reliable.

OK, minor point but I will stop referring to it as I did above as the new SRS Guidelines paper and just say the “new SRS paper”.

What I think they are assuming is that controlled studies are needed to say anything about bracing efficacy over and above watching and waiting.

No, this is not at all what they are saying in that paper.


Why do I think the SRS assumes a controlled study is necessary for this purpose? Because they say so...

In 1985, the Scoliosis Research Society (SRS) initiated a study to investigate the effectiveness of bracing as a treatment for scoliosis. Many previous studies of full time bracing showed that braces stop about 80% of curves. All of these studies, however, were "uncontrolled" which means there were no simultaneous groups of untreated, unbraced patients for comparison. Therefore, there was some doubt that brace treatment of scoliosis was effective, and concern that bracing may be no different than "natural history" or what happens when no treatment is undertaken.

Yep, the SRS said that in 1985, but it is not at all what they said in 2005 in their “new SRS paper”. But the quote you printed above brings up a really relevant point. What happened after they “initiated a study” ? They indeed did complete a study. Even better, a controlled study. It was presented by Nachemson in 1995 (10 years later in the Journal of Bone and Joint Surgery). What did the study conclude? “Treatment with a brace was successful”. Why is it relevant? I need to provide some background.

In an earlier thread (linked in my first post) Sharon led me down the path of enlightenment concerning the debate about bracing efficacy. I had originally assumed that it was a settled matter but that is not the case. My “take” on this is that Dolan and Weinstein at the University of Iowa made a case in an article published in Spine in 2007 that, based on their review of the literature, the efficacy of bracing is undetermined. But this is the thing, I am completely blown away that they excluded the, 10 year in the making, SRS supported, Nachemson study which contained 129 unbraced patients. Rather, they used data from just 2 centers that totaled 30 unbraced patients to come to their conclusion. Talk about the potential for cherry picking data. What was the outcome of their research? Guess who the principal investigators are for the current BrAIST study. Now there may be some very valid reason for all this, but before I would agree to be part of that random study I would want to have much more clarification on the issue of why the supporting study was designed in such a way as to exclude the Nachemson data. Maybe we can talk about the Nachemson paper in more detail later. EDIT after further review, I see that I am wrong. Continue reading to see this discussed further in the thread.
But I digress……

I repeat my concern... I don't see how you know what the bracing is doing without a control group.

We have beaten this issue to death. Retrospective studies do not have control groups per se. I agree that is a weakness. The “new SRS paper” attempts to strengthen future retrospective studies by establishing guidelines/criteria. Your argument is nearly identical to the arguments tobacco companies used to say there was no proof cigarettes caused cancer. I maintain that the reason there are so few controlled studies relates to ethics. The 2007 Iowa paper was essentially used to negate the ethical concerns and pave the way for the current random controlled study.

In this paper (we’re back to Coillard now), they are claiming victory mainly with smaller curves that are known not to progress.

No, Coillard excluded 112 of their patients with a Cobb angle less than 25 degrees from their analysis. Why did they do this? Because the “new SRS paper” (I would really prefer to refer to it as the SRS Guideline paper) said that only patients with initial curves between 25 and 40 degrees should be included in the study. This is detailed on the first paragraph of the second page of the Coillard paper.

But because the patients were braced they mark it in the "successful bracing" column. For all we know, none of those patients with smaller curves or even some with larger curves would have progressed anyway. Nothing in this study rules out that possibility. I continue to question the peer-review and editing of these journals.

No, not even one of the patients with an initial curve less than 25 degrees was included in their analysis.

Quote:
Originally Posted by concerned dad

“Comparing the end of bracing Cobb angle to the one at 2 years after bracing, our study reveals that the follow-up of orthopaedic treatment was a success in 95.7% of the patients, with a mean correction angle of 8.6 +/- 1.7 degrees.“.

No actually I think that statistic is quite unclear and you were right to be confused. I am still confused as to what exactly it means.

I am pretty sure I have it right. It reflects the percentage of patients initially considered to HAVE BEEN successfully braced and still had to go on to surgery within 2 years. A parameter specifically called for by the “new SRS paper”.

Here are some questions I have about that statistic:

1. It's important to realize that only 47 of the 170 patients (~28%) in the study were followed up at 2 years. Why so few? Were these predominantly the ones who started with smaller curves that wouldn't have progressed anyway?

Well, we know (as I outlined above) that they were not the ones with the smaller curves. They are the ones who both hit the 2 year post bracing mark and achieved a “successful outcome”. So, it certainly excludes the 39 patients who had surgery and it excludes the 12 who withdrew from the study. It is unclear if it excludes the 14 who were weaned before reaching skeletal maturity (although I would bet that it does.) So that still leaves 105 patients who are either still within the 2 year window or who didn’t travel back to Montreal to be monitored after bracing.

This got me thinking about updates. I went on pubmed to see if anything new was out there and found a new 2008 paper by Coillard. Instead of 47, they now have 162 patients who have reached that point. I haven’t fully waded through that paper yet.

continued on next post

concerned dad
01-09-2009, 06:33 PM
continued from above

2. I don't want to be incendiary but this is an overt case of data selection EVEN IF only 47 patients were available to them. Ask yourself what is the lower limit of percent of total patients where it wouldn't matter how many were stable?

That’s not incendiary (I was originally incendiary above in my criticism of Dolans paper – I toned it down a bit). Yeah, 47 is not a large sample, but they now have 162. That’s all they had at the time. And, I have to say, I’m glad they published their results instead of waiting. Sure, they could have presented a stronger case with more data but if you have something you believe will help children, maybe they felt they had a moral obligation to get the current results out there. I ask again, where are the bracing studies for other braces (reported in accordance with the new SRS guidelines so we parents can make actual comparisons)?

For me, ~28% is too low to draw any conclusions given that we know smaller curves will not progress despite no treatment and that we know several treated kids went on to have fusion.

Smaller curves were excluded (sorry to drive this point home). We know that, no matter what, some curves will progress.

3. What exactly do they mean by weaning point? Is that at the start of the weaning or at the end? Elsewhere they say the comparison is at the end of bracing. I take that to mean before the weaning period. How long is the weaning period? Is it 2 years or some substantial portion of that time? Why is a weaning time necessary if the brace is working? I think what needs to be compared CLEARLY is the end of the main bracing (allowing a week solid out of brace) and two years after that point (assuming the weaning period isn't more than a few months).

Good question. I don’t understand the weaning thing. Maybe it is discussed in the bracing manual on the SRS website. But, I would venture a guess that it is NOT a substantial portion of the 2 year post bracing time. The fact that they show no/little change over those 2 years post bracing seems to make the matter moot.

The two year period that the Montgomery paper talks about almost certainly doesn't involve any weaning period which is really a continuation of bracing.

You are correct, if indeed it takes two years to wean off the brace. I’m going to see if I can find out more about this weaning stuff. I see in the new paper I just downloaded, they are also reporting results 5 years post bracing (in addition to the “SRS called for” 2 year data).

Other questions I had about this paper include:

1. no control group (as mentioned above)

No further comment :)

2. extremely liberal indication for surgery of >60*! Why not 80*? Or 100* This is ridiculous as most surgeons pull the trigger at far lower Cobb angles. How would have the stats changed if they adopted a more realistic point like 45* or 50*. We scheduled surgery when my daughter was in the high 40s* (albeit with a known high rate of curvature).

To account for this, The “new SRS paper” calls for a reporting of how many patients didn’t meet the “indication for surgery” yet still progressed beyond 45 degrees. Coillard reported it, and it is 2 patients.

This is further proof that surgery recommendation or having surgery is an extremely non-robust (i.e., worthless) criteria.

You have to admit it is less “worthless” if they also tell you how many fall in between. Different countries have different criteria for surgery.

3. 101 of the 170 patients were reported to be stable after bracing. But when was that determined? Was it determined within 5 minutes of taking the brace off for the last time? Was stability determined before, during, or after the weaning period?

Good questions. You would make a good journal reviewer. It’s too bad none of the official reviewers picked up on this and pressed for clarification. But, so long as the weaning period isn’t 2 years, does it really matter? I mean, come on, the outcome for the successfully treated patients at 2 years is dramatic.

4. It is important to emphasize that these results at best strictly only apply for the group of patients that meet all criteria. 144 kids being treated didn't meet the criteria. It would be interesting to know anecdotally how they failed to meet

That’s an easy one. The criteria they failed to meet were, of course, the criteria in the “new SRS paper”. Those 144 kids were either: younger than 10, had a Risser of 3 or above or were more than 1 yr post menarchal, had a Cobb angle less than 25 degrees or more than 40 degrees. But I agree, the results only strictly apply to that specific group. However, that doesn’t mean that the results can not apply to those outside the group.

and generally how this group is doing.

Christine2 has a daughter that didn’t fall within the SRS guidelines for reporting and wasn’t included in this study (or the brand new one I just downloaded). Her curve went from over 30 degrees to about 1 degree right now. Anecdotal? Yes. But I’ll take some of what she’s having for my little girl. :D

christine2
01-09-2009, 07:29 PM
KUDOS Concerned Dad

I wish everyone on this forum could have the great results my daughter is having. We just have to be diligent to keep it that way and pray that we can make it through the growth spurt.

Pooka1
01-09-2009, 08:11 PM
I do appreciate your thoughtful comments. I was just kidding about the holding my feet to the coals stuff. It is important to me to convince myself that I am not “drinking the Kool-Aid” when it comes to the SpineCor. There certainly is a risk that a parent like myself, after facing the new news about the diagnosis, will be more susceptible to embracing miracle cures because that is what we want. I don’t think that is the case here. Your comments continually point me in new directions to evaluate and attempt to understand the scientific literature on the subject.

It's important to recall that this isn't my field. I'm making what I consider general, universal design comments. I have questions about how this stuff is done and interpreted and I may be missing some understanding.


Now, Sharon, I don’t mean to offend you on this first point. But I would bet my last dollar that you haven’t read (at least recently) the “new SRS paper” in its entirety. If you had, I don’t think you would have made several of your arguments as the SRS paper is pretty clear on many of the issues under debate.

Things like that are not inherently offensive. And you are correct. I can't find the full text of that paper. I have read the abstract. I don't see anything there as a departure from their earlier criticism of uncontrolled studies. I see it as an extension to further make progress in the area of meaningful study design. Does the full text say anything about controlled studies? Recall the site I posted about various study designs and which are viewed as better and best.

That said, even if they came out and said they were abandoning the call for controlled studies (which I doubt they did or will), I still question it. How do you know any of the bracing is working over and above watching and waiting without a control group? Anyone feel free to answer that at any time.


Yep, the SRS said that in 1985, but it is not at all what they said in 2005 in their “new SRS paper”.

No I don't see the 2005 criteria for brace comparison studies as supplanting the earlier call for controlled studies. There is no getting around the need for controls. If you think there is, please explain.


But the quote you printed above brings up a really relevant point. What happened after they “initiated a study” ? They indeed did complete a study. Even better, a controlled study. It was presented by Nachemson in 1995 (10 years later in the Journal of Bone and Joint Surgery). What did the study conclude? “Treatment with a brace was successful”. Why is it relevant? I need to provide some background.

Coincidentally, I posted this paper a little while ago for discussion. This paper appears to have serious issues in my opinion.


In an earlier thread (linked in my first post) Sharon led me down the path of enlightenment concerning the debate about bracing efficacy. I had originally assumed that it was a settled matter but that is not the case. My “take” on this is that Dolan and Weinstein at the University of Iowa made a case in an article published in Spine in 2007 that, based on their review of the literature, the efficacy of bracing is undetermined. But this is the thing, I am completely blown away that they excluded the, 10 year in the making, SRS supported, Nachemson study which contained 129 unbraced patients. Rather, they used data from just 2 centers that totaled 30 unbraced patients to come to their conclusion. Talk about the potential for cherry picking data. What was the outcome of their research? Guess who the principal investigators are for the current BrAIST study. Now there may be some very valid reason for all this, but before I would agree to be part of that random study I would want to have much more clarification on the issue of why the supporting study was designed in such a way as to exclude the Nachemson data. Maybe we can talk about the Nachemson paper in more detail later.

I think there is very good reason for not including the Nachemson and Peterson paper. They were correct to exclude it.


Retrospective studies do not have control groups per se.

I don't see why not. If you can assemble a treatment groups retrospectively, why can't you assemble a control group in the same manner??? This is outside my field and there may be some esoteric reason but I can't imagine what it is.


I agree that is a weakness.

That's an understatement. How do you know if the brace is doing anything without a control group? It could be that the brace is doing nothing but you wouldn't know it with out a control group.


The “new SRS paper” attempts to strengthen future retrospective studies by establishing guidelines/criteria. Your argument is nearly identical to the arguments tobacco companies used to say there was no proof cigarettes caused cancer. I maintain that the reason there are so few controlled studies relates to ethics. The 2007 Iowa paper was essentially used to negate the ethical concerns and pave the way for the current random controlled study.

I'm sorry but I am not following here. It is simplicity itself to compare (huge) populations of smokers ("treatment" group) and non-smokers (control group) even today.

In re "smaller" curves...


No, Coillard excluded 112 of their patients with a Cobb angle less than 25 degrees from their analysis. No, not even one of the patients with an initial curve less than 25 degrees was included in their analysis.

By smaller I mean at the low end of the range they studied. There is quite a large jump in the likelihood of curve progression in curves below 30 or 35 let's say and those above 40*. It's an exponential (or nearly so or power function or something) curve. Thus small increments in curves translate to relatively larger increases in the chance of progression. Therefore I'm guessing many/most of the "successfully braced" curves started out at the beginning of the study at the low end of the studied range.

I have no comments on your second post.

Pooka1
01-10-2009, 10:58 AM
Christine2 has a daughter that didn’t fall within the SRS guidelines for reporting and wasn’t included in this study (or the brand new one I just downloaded). Her curve went from over 30 degrees to about 1 degree right now. Anecdotal? Yes. But I’ll take some of what she’s having for my little girl. :D

I stumbled across this when looking for some progression curves...

Heary and Albert, p.95 (http://books.google.com/books?id=cZu3_EezS_wC&pg=PA95&lpg=PA95&dq=graph+ais+risk+of+progression&source=bl&ots=JrfIzlun-W&sig=yMO2NXTKIZNeviIQdyGMXZrsYO4&hl=en&sa=X&oi=book_result&resnum=1&ct=result) (bottom right)

A 5-year prospective study of 85,622 kids found 1,436 kids with scoliosis.

Results over an average observation of 3.2 years:

Progression - 14.7%
Spontaneous improvement of at least 5* - 27.4%
Complete spontaneous resolution - 9.5%

Here is yet another reason why controls are needed. About twice as many kids improved compared to the kids who got worse. And significantly, almost 10% of the kids in this study had a complete spontaneous resolution of the scoliosis.

Had they happened to be enrolled in a Spinecor study at the time, these spontaneous improvement and resolutions would have be chalked up to the efficacy of the Spinecor brace. The bracing literature that doesn't address controls is clearly part of the reason why most published research results are false.

We can't assume that any child in a Spinecor brace would not have completely resolved on their own absent the brace.

This literature has to be cleaned up quickly in my opinion.

leahdragonfly
01-10-2009, 12:42 PM
Hi Concerned Dad,

I haven't had time to read all the posts here thoroughly, so pardon me if this topic has been discussed. Clearly the bracing literature is very controversial. As parents we each have to decide what treatment we feel is best for our child at the time. For some of us it is extremely important to feel our decisions are backed by sound scientific research--others, less so.

One major problem I see with bracing research is that the issue of non-compliance with the prescribed brace wear is almost completely ignored. All children who were in the braced groups were ASSUMED to have been 100% compliant with their brace-wearing. Since 23/7 bracing (with a hard brace anyway) is almost impossible to consistently achieve in the real world, it is a very dangerous assumption to make. It means that some kids' curves that are chalked up to being successfully braced, stayed stable even though the child did not wear the brace as much as prescribed. I was one of those kids. To me this problem alone invalidates most of the bracing research, as it gives false credit to bracing as a successful treatment when in fact the brace wasn't the reason the curve stable. Does this make sense?

At least the BrAIST study that is underway seems to address this by having temperature sensors in each brace to accurately determine brace wear.

Pooka1
01-10-2009, 01:05 PM
I agree with Gayle that compliance is a major confounder in the brace literature.

But I see the result being a potentially false negative and that braces might in fact be more effective than we can presently show.

That is, if everyone wore the brace the prescribed number of hours, it certainly might be the case that bracing is more effective than watching and waiting. But we can't know unless we get a handle on the compliance within a controlled study.

I have been thinking about this and I think the use of averages when there is so much natural and other variation is not going to be fruitful. I think it's time to go to individual-based models. The issue I brought up early about the propensity of curve increase related to degree of curve makes this seem obvious. When you add that Risser is also known to be highly correlated with propensity of curve progression, then I think that, with all the other reasons, calls for individual-based models.

Now I am not a statistician and I have never used these types of models. But I have taken note of the fact that certain folks in fields related to mine have gone to these models for a reason. As far as I can tell, bracing study results would be far more robust if using these models. Averaging over smallish populations with several known confounders is not likely going to produce clear, "true" results as far as I can tell.

concerned dad
01-11-2009, 08:00 AM
I stumbled across this when looking for some progression curves...

Heary and Albert, p.95 (http://books.google.com/books?id=cZu3_EezS_wC&pg=PA95&lpg=PA95&dq=graph+ais+risk+of+progression&source=bl&ots=JrfIzlun-W&sig=yMO2NXTKIZNeviIQdyGMXZrsYO4&hl=en&sa=X&oi=book_result&resnum=1&ct=result) (bottom right)

A 5-year prospective study of 85,622 kids found 1,436 kids with scoliosis.

Results over an average observation of 3.2 years:

Progression - 14.7%
Spontaneous improvement of at least 5* - 27.4%
Complete spontaneous resolution - 9.5%

Here is yet another reason why controls are needed. About twice as many kids improved compared to the kids who got worse. And significantly, almost 10% of the kids in this study had a complete spontaneous resolution of the scoliosis.


That was an interesting book you linked to. Too bad google doesnt offer the complete text, but there is a lot there still.
Regarding that specific study you cited, I looked up the abstract (couldnt get the entire paper). But, it looks like they included kids who had curves as low as 10 degrees.
Curve progression was studied in 839 of the 1,436 children with idiopathic scoliosis of at least 10 degrees detected from the school screening program
We know many small curves dont progress. Again, this is part of the reason for the SRS guidelines calling for studying bracing efficacy in curves between 25 and 40.
They didnt stratify their results in the abstract, perhaps in the paper, but I would GUESS that the majority of spontaneous corrections occurred in the smaller curves.
they do say
More specifically, the following were associated with a high risk of curve progression: <snip> and curve magnitude (> or = 30 degrees).


Had they happened to be enrolled in a Spinecor study at the time, these spontaneous improvement and resolutions would have be chalked up to the efficacy of the Spinecor brace. The bracing literature that doesn't address controls is clearly part of the reason why most published research results are false.

We can't assume that any child in a Spinecor brace would not have completely resolved on their own absent the brace.


All those kids would not have been enrolled in the study, the SRS guidelines would have excluded the vast majority



This literature has to be cleaned up quickly in my opinion.

The SRS would seem to agree with you, that's why they established the guidelines for future bracing studies. To make them MORE meaningful. Not to make them 100% conclusive (as a random controlled study would approach), but to improve the interpretive significance of the literature.

The SRS guidelines basically said, (liberally paraphrasing here)
hey folks. listen up. if you're going to continue publishing these retrospective uncontrolled studies, at least use consistent criteria so we can try to make some sense out of all this.

and so far, 4 years later, the ONLY people who are willing to present their data in accordance with the new guidelines are the SpineCor folks.
And there has to be a ton of data for the other braces. Where is it?

I do have some comments on your other post, and I do want to discuss Nachemson. Right now I'm working my way through the new Coillard paper that updates their results since 2007.
Might I suggest we keep the discussion to this thread. We are probably boring the heck out of people.

concerned dad
01-11-2009, 08:06 AM
I agree with Gayle that compliance is a major confounder in the brace literature.

But I see the result being a potentially false negative and that braces might in fact be more effective than we can presently show.

Thank you. Yes, it is a confounder. It could affect results one way or the other.

concerned dad
01-11-2009, 08:14 AM
I have been thinking about this and I think the use of averages when there is so much natural and other variation is not going to be fruitful. I think it's time to go to individual-based models. The issue I brought up early about the propensity of curve increase related to degree of curve makes this seem obvious. When you add that Risser is also known to be highly correlated with propensity of curve progression, then I think that, with all the other reasons, calls for individual-based models.


Wow, Sharon, I'm impressed. Even though you didnt read the full SRS guidelines, you could have been the one to write them.

This is exactly why they call for (actually, I think they use the word 'encourage") reporting the data using stratification of results.

:)

Pooka1
01-11-2009, 08:18 AM
That was an interesting book you linked to. Too bad google doesnt offer the complete text, but there is a lot there still.
Regarding that specific study you cited, I looked up the abstract (couldnt get the entire paper). But, it looks like they included kids who had curves as low as 10 degrees.

Yes. That was implied when they said these kids had scoliosis. That is the minimum angle everyone uses for the definition as far as I know.

(snip)


All those kids would not have been enrolled in the study, the SRS guidelines would have excluded the vast majority

Maybe but we don't know that. We need to see the distribution of curves and the distribution of curves that completely straightened and follow individuals perhaps. This (brace research in general) may be an obvious instance where individual-based models are needed. I think it is but I don't work with this kind of stuff so I don't really know.


(snip)
The SRS guidelines basically said, (liberally paraphrasing here)
hey folks. listen up. if you're going to continue publishing these retrospective uncontrolled studies, at least use consistent criteria so we can try to make some sense out of all this.

and so far, 4 years later, the ONLY people who are willing to present their data in accordance with the new guidelines are the SpineCor folks.
And there has to be a ton of data for the other braces. Where is it?

Perhaps they have decided to stop publishing uncontrolled studies? Can you tell me how you know anything of what a brace is doing is you don't have a control group?


I do have some comments on your other post, and I do want to discuss Nachemson. Right now I'm working my way through the new Coillard paper that updates their results since 2007.

Can you post this paper?

Pooka1
01-11-2009, 08:20 AM
Wow, Sharon, I'm impressed. Even though you didnt read the full SRS guidelines, you could have been the one to write them.

This is exactly why they call for (actually, I think they use the word 'encourage") reporting the data using stratification of results.

:)

I'm not sure but I don't think stratifying the results is the same as individual-based modeling but it seems like it as a step towards that. We need someone who knows about this stuff to comment.

concerned dad
01-11-2009, 10:39 AM
Can you post this paper?

I am trying to find a publicly available link. So far, no luck. I bought the paper for 15 euro's from the publisher. Looks like a paper from a sosort conference. I imagine that soon it will be available on the Spinecorporation website.
I could attach it here but am afraid it would violate copywrite laws and NSF would need to remove it.

But, while looking, I came acrosss something disturbing/confusing.
here (http://www.spinecorporation.com/English/ScientificInformation/C-Greece-2003%20Dr%20Coillard-Barcelone%202004001.pdf) they have reference to weaning. Look at page 37. They have a an xray of a patient there with text "weaning time:62 months"

Now to me, weaning means a gradual withdrawal of something. I wonder if this is a language thing or if indeed this patient has worn a brace for a large part of those 62 months following the "weaning date".

Are there any forum participants who have been "weaned" off the SpineCor who could shed some light on this? I am thinking it is a language thing, but as Sharon points out above, IF the brace was worn after treatment ended then there are some serious implications for assessing the "permanent" aspect of success

concerned dad
01-11-2009, 12:29 PM
OK, it looks like the weaning period takes 6 months.
At the weaning evaluation visit, the patient is xrayed (after not wearing the brace for 72 hours).
Then, the brace is put on and another in brace xray is taken
if the two differ by less than 5 degrees, weaning commences

Weaning consists of wearing the brace 10 hours a day for 6 months, then
show up for appt after NOT wearing the brace for 3 days (72 hours).
Take out of brace xray

Then take in brace xray

If difference is less than 5 degrees, complete discontinuation of brace.

LindaRacine
01-11-2009, 02:21 PM
They have a an xray of a patient there with text "weaning time:62 months"

I suspect it's a typo. It was probably 6.2 months.

RugbyLaura
01-11-2009, 02:51 PM
We are probably boring the heck out of people.

No way! This is fantastic stuff!! Please keep it up!!!

(Just because we're not posting, it doesn't mean we're not reading avidly :))

mamandcrm
01-11-2009, 05:20 PM
This probably is best addressed to Christine2, who has a young daughter in Spinecor, or anyone with familiarity with Spinecor and JIS patients. Do you anticipate that she will have to remain full-time in the Spinecor brace until skeletal maturity despite her correction (I'm not sure if that is in-brace or out of brace--it's my recollection that Spinecor does not emphasize out of brace xrays until later in the bracing process)? Are there more criteria for initiating the weaning process than maturity?

Thanks, mamandcrm

mamandcrm
01-11-2009, 05:38 PM
By the way, interesting discussion. Thanks for the detailed look at the research.

Pooka1
01-11-2009, 07:01 PM
I think it needs constant emphasizing that nobody in this discussion has as their field bracing research. Nobody is an orthopedic surgeon.

While it might look like we are doing detailed analyses of the papers, I strongly suspect I, at least, am missing a boatload of important information. My critiques can only go so far and, by definition, just can address the scientific method as opposed to this field in particular.

Pooka1
01-11-2009, 07:39 PM
OK, it looks like the weaning period takes 6 months.
At the weaning evaluation visit, the patient is xrayed (after not wearing the brace for 72 hours).
Then, the brace is put on and another in brace xray is taken
if the two differ by less than 5 degrees, weaning commences

Weaning consists of wearing the brace 10 hours a day for 6 months, then
show up for appt after NOT wearing the brace for 3 days (72 hours).
Take out of brace xray

Then take in brace xray

If difference is less than 5 degrees, complete discontinuation of brace.

24 month weaning (http://www.spinecorporation.com/English/ScientificInformation/C-Greece-2003%20Dr%20Coillard-Barcelone%202004001.pdf)

Someone correct me if I'm wrong but this seems to be a case where the weaning period was identical to the "magic" 2-year period post-bracing.

In other words, they are technically following the criteria to present data from 2-years post "bracing" but the patient wore the brace about half the day, every day for the entire 2-year period!

Are we on Candid Camera??? :eek:

concerned dad
01-11-2009, 07:53 PM
I think it needs constant emphasizing that nobody in this discussion has as their field bracing research. Nobody is an orthopedic surgeon.

While it might look like we are doing details analyses of the papers, I strongly suspect I, at least, am missing a boatload of important information. My critiques can only go so far and, by definition, just can address the scientific method as opposed to this field in particular.

I KNOW I'm missing a lot.

The more I look at this stuff, the more I realize how little I know.

Good reminder Sharon

As an example, although I'm too tired now to go into it in detail, I see what the problem with the Nachemson paper is. It has to do with how they grouped curve types between the control group and the braced group.

From a 1999 paper by Dickson in Spine discussing Nachemson.....

One hundred and eleven braced patients were compared to 129 observed and 46 electrically stimulated. The failure rate was an increase in Cobb angle by 6°. On this basis 36% of the braced, 52% of the observed, and 63% of the stimulated failed and these differences achieved statistical significance. The next paper in the same journal looked at factors that affect natural history
and one of the most compelling features was that thoracic curves had a much worse prognosis than thoracolumbar curves. Looking now at the proportions of the more progressive thoracic curves in the three trial groups, 89% were thoracic in the stimulated group, 81% in the observed group, and a mere 68% in the braced group. Meanwhile, in the paper originating in Puerto
Rico, 70% of the untreated group had thoracic curves and 46% of the treated group. It would be difficult to stack the odds better.
:confused:

maybe i should further tone down my criticism of Dolan in my post above.

Pooka1
01-11-2009, 08:12 PM
Good analysis, Concerned Dad.

There are other issues in that paper besides the one you mentioned.

This issue of stacking patients in one or the other group, whether it is conscious or not, makes the case for individual-based modeling in my opinion.

If they had simply shown distribution profiles in the original paper, it would never have been published in my opinon. Why the reviewers didn't ask for them, I don't know.

I continue to question the peer-review and editing in these journals.

LindaRacine
01-11-2009, 11:47 PM
24 month weaning (http://www.spinecorporation.com/English/ScientificInformation/C-Greece-2003%20Dr%20Coillard-Barcelone%202004001.pdf)

Someone correct me if I'm wrong but this seems to be a case where the weaning period was identical to the "magic" 2-year period post-bracing.

In other words, they are technically following the criteria to present data from 2-years post "bracing" but the patient wore the brace about half the day, every day for the entire 2-year period!

Are we on Candid Camera??? :eek:
I suspect that Drs. Rivard and Colliard have little control over weaning time. It seems like I'm constantly hearing from parents who tell me they've been told to wean their kids off the brace. But either the parents, or even the kids themselves, keep the brace on despite the contrary instruction.

--Linda

Pooka1
01-12-2009, 07:17 AM
Based on the criteria posted about indication for weaning, I am guessing the majority of patients are simply slowing the curvature relapse during the weaning period and only stop when they hit their original (or higher) Cobb angle. Spinecor is new enough such that they can squeeze a few more papers out in the mean time which will later be (or should be) retracted.

I want to see the percentages of patients who:

1. needed at least one weaning period (of 6 months)
2. of those, the percentage who needed two weaning periods
3. of those, the percentage who needed three or more weaning periods.
4. The percentage of patients who came back to the same angle (+/- 5*) they started with before bracing two years after the brace comes off for good.

I don't think there is any clear evidence Spincor has improved a single curve long term at this point. They may have helped hold curves but we can't really know that without controls.

And just to be clear we also don't know that Spinecor is NOT working as advertised. Until these authors crunch the data in a reasonable fashion, we can't know either way. It's not enough to execute a bracing study. You have to have a good design and know how to present the data if want to make a case.

Pooka1
01-12-2009, 07:22 AM
I suspect that Drs. Rivard and Colliard have little control over weaning time. It seems like I'm constantly hearing from parents who tell me they've been told to wean their kids off the brace. But either the parents, or even the kids themselves, keep the brace on despite the contrary instruction.

An obvious explanation for your anecdotal observation is these kids are failing the trial weaning and don't want to see any further deterioration so they just continue wearing the brace (for life?).

There is something vague about the Spinecor papers on this weaning business. I can't tell if it is deliberate or not. It is outrageous that the paper we were discussing did not rigorously define all these terms (e.g., "stable," "weaning point," etc.).

They need to pony up the data on how many patients fail the first weaning test and how many relapse completely to the original curve (or worse) two years after the brace is removed for good. Forget publishing all the weaning crap.

Pooka1
01-12-2009, 08:29 AM
I suspect it's a typo. It was probably 6.2 months.

Based on the dates, 62 month (over five years) is correct.

concerned dad
01-12-2009, 10:49 AM
I don’t have much time right now but I just wanted to follow up with some thoughts.
I slept poorly last night. This revelation from the Dickson paper hit me like a ton of bricks.
What does it mean? Besides the fact that <gulp> I was wrong and Sharon was right (with regard to the big picture of what we KNOW about brace efficacy), it means that we really do not KNOW that bracing has a positive affect.
Of course, we don’t KNOW the opposite either. It may indeed have a positive affect. (And no one should be discouraged or cease their current therapy.)

Now, perhaps I should have realized this sooner because Sharon pointed it out. I don’t, (and neither should anyone) believe everything (or anything) I read on forums like these. But the discussions are useful to steer one in the right directions to gain personal understanding.

For me, the revelation enforces my decision to go with the SpineCor. I’m not sure if that makes sense to everyone but I can get into that later.

I disagree with Sharon about the integrity of the researchers (maybe that’s not the right word but the whole “questioning the peer review process” stuff). This Nachemson data (which is “The SRS Bracing Study) was published in the SAME issue as the data indicating that different TYPES of curves have different progression characteristics. These guys did not know this before the study came out. Wow, 10 years wasted. I hope someone has looked into salvaging info from the Nachemson study, but I have not seen that discussed yet in my search.

I now understand why the new BrAIST study can and should proceed. Apologies for my criticism of Dolan (and I will edit my post above).

This is a good example of how science works. Consensus means very little (if anything). I imagine that, if the results of the NEW bracing study reveal bracing to be ineffective it will have consequences to the ortho field similar to what the 1960’s discovery of Plate Tectonics had to the field of geology. It may upset the whole apple cart. Similarly, the field of Climate Science, while boasting of a consensus, needs to ensure that their results are scientific and defensible.

But I digress,
Regarding weaning, Linda – no, I don’t think the 62 months is a typo. Neither do I think it is nefarious Sharon. I expect that it is a language issue. I agree Sharon that the journal reviewers should have caught this and pressed for a definition. Text from the new Coillard paper (2008) says (also in the 2007 Coillard paper): (emphasis added is mine)

“As reported by Montomery and collaborators, a follow up of 2 years is sufficient to foresee progression after weaning from the brace.”

So they clearly understand the issue. What needs to be clarified is if their two year data is indeed “after weaning” or if it includes patients who are still being weaned. I suspect that it does not include patients still being weaned (braced part time), but I can’t say for sure based on what I’ve read.





I want to see the percentages of patients who:

1. needed one weaning period (of 6 months)
2. of those, the percentage who needed two weaning periods
3. of those, the percentage who needed three or more weaning periods.
4. The percentage of patients who came back to the same angle (+/- 5*) they started with before bracing two years after the brace comes off for good.



For me, it is too early to jump to conclusions based on the “weaning issue”. But I agree that I would like to see the 4 numbers Sharon asked for above. Most importantly for me, the last one. And this is driven home more by a figure in the linked presentation showing “Weaning Time: 62 months”.

Pooka1
01-12-2009, 11:22 AM
I don’t have much time right now but I just wanted to follow up with some thoughts.
I slept poorly last night. This revelation from the Dickson paper hit me like a ton of bricks.

I'm sorry to hear that.


What does it mean? Besides the fact that <gulp> I was wrong and Sharon was right (with regard to the big picture of what we KNOW about brace efficacy), it means that we really do not KNOW that bracing has a positive affect.

I see us as being on the same side. This is about mutually trying to come to some better understanding through a dialectic in this case.


Of course, we don’t KNOW the opposite either. It may indeed have a positive affect. (And no one should be discouraged or cease their current therapy.)

Right. I have seen nothing that rules out that bracing works. It might work. But the people who know this should show it.

(snip)


I disagree with Sharon about the integrity of the researchers (maybe that’s not the right word but the whole “questioning the peer review process” stuff). This Nachemson data (which is “The SRS Bracing Study) was published in the SAME issue as the data indicating that different TYPES of curves have different progression characteristics. These guys did not know this before the study came out. Wow, 10 years wasted. I hope someone has looked into salvaging info from the Nachemson study, but I have not seen that discussed yet in my search.

Well I'm just saying it's not clear what the Spinecor or other researchers are or are not trying to do with the data. W.R.T. peer review, defining all terms is reviewing 101. I realize there necessarily is some jargon in all scientific articles but when you are breaking new ground like in the case of weaning, and especially in the first instance of usage in the published literature, you define the terms. And certainly is you claim to be following some other set of criteria like the SRS one, you have to be extra clear when you have something called "weaning" that isn't addressed in the criteria.

(snip)


This is a good example of how science works. Consensus means very little (if anything). I imagine that, if the results of the NEW bracing study reveal bracing to be ineffective it will have consequences to the ortho field similar to what the 1960’s discovery of Plate Tectonics had to the field of geology. It may upset the whole apple cart. Similarly, the field of Climate Science, while boasting of a consensus, needs to ensure that their results are scientific and defensible.

Agree. And plate tectonics was nail number five bazillion in the coffin of young earth creationism, BTW.


But I digress,
Regarding weaning, Linda – no, I don’t think the 62 months is a typo. Neither do I think it is nefarious Sharon. I expect that it is a language issue. I agree Sharon that the journal reviewers should have caught this and pressed for a definition. Text from the new Coillard paper (2008) says (also in the 2007 Coillard paper): (emphasis added is mine)

Those data have not been published as far as I know. They are still at the stage of being a Powerpoint presentation. I can tell you from personal experience that what I have presented at scientific meetings and what ends up in the journal can be very different. The presentation is not peer-reviewed. The journal articles hopefully are. Don't bank on ANYTHING that is still at the Powerpoint point. ;)


“As reported by Montomery and collaborators, a follow up of 2 years is sufficient to foresee progression after weaning from the brace.”

So they clearly understand the issue. What needs to be clarified is if their two year data is indeed “after weaning” or if it includes patients who are still being weaned. I suspect that it does not include patients still being weaned (braced part time), but I can’t say for sure based on what I’ve read.

I suspect you are right because the alternative is hard to imagine given how these data have been presented. That is, most people would form an opinion of the integrity of the Spinecor folks if it turns out that patients were braced at any point in the 2-yr post-bracing period. If that turned out to be the case without them CLEARLY saying that was the case, I can tell you I will not waste my time reading further papers from these authors.


For me, it is too early to jump to conclusions based on the “weaning issue”. But I agree that I would like to see the 4 numbers Sharon asked for above. Most importantly for me, the last one. And this is driven home more by a figure in the linked presentation showing “Weaning Time: 62 months”.

I'd also like to know what the Cobb angle was on that patient at the beginning of brace treatment. Details, details.

concerned dad
01-12-2009, 11:57 AM
I see us as being on the same side. This is about mutually trying to come to some better understanding through a dialectic in this case.



I meant it in the sense of how we are exploring these issues. We are loosely using the Socratic method where two or more people assist one another in finding the answers to difficult questions by questioning and taking opposing viewpoints.

When is it going to be my turn to play Socrates :)

concerned dad
01-12-2009, 12:05 PM
regarding the 62 month patient....


I'd also like to know what the Cobb angle was on that patient at the beginning of brace treatment. Details, details.

the x-rays are identified with patient numbers.
This patient had:
Th40 L40 in 1995 (treatment started)
weaning started (whatever that means) in 1997
Th32 L30 in 1999
Th27 L31 in 2002

Pooka1
01-12-2009, 04:11 PM
Ah, I have lost the train of thought but I think my reference was to Patient #1382470. It was unclear because I didn't add the slide number thinking it was in the url I posted.

In re Patient #1382470, as far as I can tell, this is her history...

28 May 1996 - presents with L23 (RELATIVELY SMALL CURVE!!!)
28 May 1996 - can reduce it to L14 by standing oddly

13 June 1996 - gets brace on - shoot an immediate L6

17 July 1996 - L0

(no data presented for over 3.5 years)

10 Feb 2000 - now presents with a TL15 w/out brace therefore curve moved upward
10 Feb 2000 - TL9 w/brace

(no data for 1.5 years)

23 Aug 2001 - TL11 in brace(?)

21 Aug 2002 - TL11 in brace(?)

No data presented for period after 21 Aug 2002 despite the fact that I believe the Powerpoint is quite recent. Why?

concerned dad
01-12-2009, 06:20 PM
Ah, I have lost the train of thought but I think my reference was to Patient #1382470. It was unclear because I didn't add the slide number thinking it was in the url I posted.


Yeah, above I was referring to the one weaned 62 months



In re Patient #1382470, as far as I can tell, this is her history...

28 May 1996 - presents with L23 (RELATIVELY SMALL CURVE!!!)
28 May 1996 - can reduce it to L14 by standing oddly



I got a good laugh out of this. I thought you meant that it was odd that her curve changed when she was standing. I'm looking to see evidence in the previous xray that she was sitting. Then I realized what you meant.
Anyway, remember we do not know the context in which these slides were shown. I am guessing that the "standing oddly" was somehow showing the corrective posture or movement.

regarding the small curve, perhaps they were addressing the K20 and L60 (whatever exactly that means) aspect of her curve.




13 June 1996 - gets brace on - shoot an immediate L6

17 July 1996 - L0

(no data presented for over 3.5 years)

10 Feb 2000 - now presents with a TL15 w/out brace therefore curve moved upward
10 Feb 2000 - TL9 w/brace



recall what I posted above concerning the weaning protocol. Take an xray after being out of brace for 72 hours, then another xray in brace. If the difference is less than 5 degrees then stop all bracing.
Here the difference is 6 degrees. And we know, you cant measure that accurately. So, I am GUESSING that this marked the end of brace treatment entirely.

But the math is wrong. 24 months would imply that she failed the 5 degree test. Wore the brace part time for another 6 months. And then finally passed the 5 degree test.



(no data for 1.5 years)

23 Aug 2001 - TL11 in brace(?)

21 Aug 2002 - TL11 in brace(?)


Not sure why you question if it is in brace or not. The brace is clearly visable in the inbrace x-rays.
That's a belly button ring I think. Not a brace grommet.





No data presented for period after 21 Aug 2002 despite the fact that I believe the Powerpoint is quite recent. Why?

Well, who knows how far this patient had to travel back to Montreal. If I am interpreting this right, it demonstrates a stable curve after several years. Maybe she figured - Why bother going back, move on with life.
A curve that presented in a 10 year old girl corrected from 23 to 11? Not bad. Perhaps they were also addressing the K20 and L60 as the side view is also shown in the last slide of the series. K20 and L60 went to 34 and 43 (whatever that means - I think it relates to the 3 dimensional aspect of the curve but my mind is sort of stumped when we get much past even one dimension)

Pooka1
01-12-2009, 06:50 PM
(snip)
regarding the small curve, perhaps they were addressing the K20 and L60 (whatever exactly that means) aspect of her curve.

I believe:
K = kyphosis
L = lumbar and lordosis
C = cervical


Well, who knows how far this patient had to travel back to Montreal. If I am interpreting this right, it demonstrates a stable curve after several years. Maybe she figured - Why bother going back, move on with life.
A curve that presented in a 10 year old girl corrected from 23 to 11? Not bad.

I think some very high percentage of L23 curves never progress no matter what you do (or don't do).

I'd like to see them present a T30-something case history.

concerned dad
01-12-2009, 07:29 PM
I believe:
K = kyphosis
L = lumbar and lordosis
C = cervical


I think some very high percentage of L23 curves never progress no matter what you do (or don't do).

Well, how many "spontaneously correct" to 11? Heck, if it went to 10 they might be able to claim a cure.



I'd like to see them present a T30-something case history.

Isnt the Th40 I noted above an example? Again, the abbreviation/shorthand is foreign to me.
This patient had:
Th40 L40 in 1995 (treatment started)
weaning started (whatever that means) in 1997
Th32 L30 in 1999
Th27 L31 in 2002

Can we expect many 40 degree curves to correct 33%?
And, the more I look at this the more I am convinced about the weaning thing. If I am interpreting it correctly, it means that not only did the curve correct 33%. But held the correction (and even improved?) 5 years after all bracing ceased.

Maybe something can be gained from the failed bracing study. If we, for the sake of argument, assume for a moment that the bracing in the SRS/Nachemson study had no affect, cant we use that group as a "worst case" control? Recall, the bracing study did NOT include the SpineCor.

Pooka1
01-12-2009, 09:19 PM
Isnt the Th40 I noted above an example? Again, the abbreviation/shorthand is foreign to me.
This patient had:
Th40 L40 in 1995 (treatment started)
weaning started (whatever that means) in 1997
Th32 L30 in 1999
Th27 L31 in 2002

Can we expect many 40 degree curves to correct 33%?

When did weaning end prior to the 1999 measurement?

Based on the stated criteria IIRC, I don't think this patient wore any brace between 1999 and 2002 but I'm not sure. There could have been data in-between where she failed the weaning criteria and wore the brace in this period. Had the Spincor literature been clearer (N.B., I'm not gigging the PP slides here) there wouldn't be any rooom for wonder.

Also, we can expect a +/- 10* on the same radiograph if two different readers are involved as I understand it.


And, the more I look at this the more I am convinced about the weaning thing. If I am interpreting it correctly, it means that not only did the curve correct 33%. But held the correction (and even improved?) 5 years after all bracing ceased.


That could be right if we knew clearly when all bracing ceased.


Maybe something can be gained from the failed bracing study. If we, for the sake of argument, assume for a moment that the bracing in the SRS/Nachemson study had no affect, cant we use that group as a "worst case" control? Recall, the bracing study did NOT include the SpineCor.

All that data can be used with IBMs I think.

Pooka1
01-12-2009, 09:28 PM
No data presented for period after 21 Aug 2002 despite the fact that I believe the Powerpoint is quite recent. Why?

I don't know which idiot wrote this but I now think that talk was given in 2003, maybe not even a year after the last data point for the patient in question. :eek::D

concerned dad
01-12-2009, 10:34 PM
slow down there...
You have me googling IIRC and IBM.

IIRC - if I recall correctly, OK
but IBM?
do you mean this thing I'm typing on? or is it some scolio term dealing with bracing models or something?

Pooka1
01-13-2009, 07:45 AM
slow down there...
You have me googling IIRC and IBM.

IIRC - if I recall correctly, OK
but IBM?
do you mean this thing I'm typing on? or is it some scolio term dealing with bracing models or something?

IBM = individual based modeling. I got tired of writing it out. :)

Pooka1
01-15-2009, 08:57 AM
In re the patient with a putative stable TL11...


Not sure why you question if it is in brace or not. The brace is clearly visible in the inbrace x-rays. That's a belly button ring I think. Not a brace grommet.

The problem is we don't know when this patient last took off the brace. Maybe it was five minutes before that radiograph. If so, that is essentially close to the in-brace angle despite the fact the brace is not worn for the radiograph.

That was my point.

Given Linda's anecdotal observation that many patients go against advice and simply continue to wear the brace more hours and beyond the end of the weaning protocol, I think we have to be skeptical of these long-term Spinecor results per se. That is unfortunate because that really is no fault of the researchers. Essentially, they may in fact not have enough control over the study to ever publish.

I don't know that but I'm saying we need to rule that out at this point in a very convincing fashion.

Last, this weaning business is inherently squirrelly. Do other braces have a weaning period? Isn't the fact that a weaning period is specified for all patients even those past skeletal maturity problematic?

It is now incumbent on the Spinecor types to publish CLEAR data on when the brace was last removed prior to a radiograph and to somehow vouch that the patient isn't secretly wearing it. I suspect most patients who fail the first weaning are wearing that brace full time and longer than 6 months against protocol.

jillw
01-15-2009, 05:05 PM
In re the patient with a putative stable TL11...

Do other braces have a weaning period? ....

Others would have a more definite answer to that question, but of the two people with scoliosis bracing that I personally knew, they both were weaned of their braces. One wore a Milwaukee and one wore a Boston brace. Caveat - not only is this anecdotal, but these people are adults now and I don't know if protocol has changed.

Pooka1
01-17-2009, 05:39 PM
(snip)
But what about the data for the SpineCor? A paper published in 2007 (Colliard, Journal of Pediatric Orthopedics) complied with the new SRS guidelines for bracing studies. (And, correct me if I am wrong, I think this is the first Brace paper that came out presenting data in accordance with the new SRS guidelines).

The following article uses the new SRS criteria is in the same journal volume and number but was printed on pp. 369-374 whereas the the Spinecor article immediately follows on pp. 375-379.

Janicki, et al., 2007 (http://www.ncbi.nlm.nih.gov/pubmed/17513954?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum)

So technically, it was published "first." :D :D :D

concerned dad
01-18-2009, 07:31 AM
The following article uses the new SRS criteria is in the same journal volume and number but was printed on pp. 369-374 whereas the the Spinecor article immediately follows on pp. 375-379.

Janicki, et al., 2007 (http://www.ncbi.nlm.nih.gov/pubmed/17513954?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum)

So technically, it was published "first." :D :D :D

Absolutely correct, it was first. I totally missed that paper and I was even looking at the table of contents of the journal.
But the results are very discouraging for the two braces studied. Particularly for larger curves. They say:
The results of both orthoses were unfavorable when
compared with previous studies and the natural history of the
condition. Neither orthosis was effective, when compared
with the natural history of AIS, at preventing progression to
surgery in subset of patients with curves of 35 degrees or
more. Although not included in this analysis, our patients
with initial curves of 41 to 45 degrees also had poor results
using either orthosis. The use of a TLSO did not prevent curve
progression or the need for surgery in only 20% to 25% of our
patients. This was true even when the initial curves of 25 to
35 degrees were evaluated separately. The Providence
orthosis did not prevent curve progression or surgery in
40% to 55% of patients. The best results were obtained in
curves of 25 to 35 degrees. On the basis of these results, we
are reconsidering our guidelines and are considering orthotic
management in skeletally immature patients with progressive
curves of 20 to 24 degrees.

My daughters curve is high (38 degrees two months ago) and they had no success with curves like this. ZERO, NADA. I'll be interested to see if (and by how much) it progressed since late November.
I'm in Syracuse now on my way to Montreal. I wish I had a printer so I could print this paper out and compare it with the Coillard one.

Another issue I thought I would throw out there regards the Boston Brace. I was figuring that if anyone would be financially concerned about the current BrAIST study it would be them as they sort of have the market cornered. I went on their website thinking that if they were a publicly traded company they may have a statement or comment in a note to shareholders or something. This is the kind of stuff that, if you were a shareholder, you would want to see disclosed (and I think Sarbanes Oxley would require it).
Anyway, I didnt find what I was looking for. Apparently it is privately held and there are no links to shareholder documents. But I did see two things that interested me.
The first was a reference to a paper on their website
Brace Treatment of Idiopathic Scoliosis: What Makes Sense in the New Millennium
John B. Emans, MD; SPINE: State of the Art Reviews, Volume 14, No. 1, January 2000. That looked like an interesting one to read, but I couldnt find it anywhere. I was able to access that issue of SPINE electronically but did not find it. Perhaps it is a special volume or something. If anyone has a pointer for that paper I would be interested.

The other thing I noticed on the boston brace website is a "new" brace that is based on "dynamic" treatment principals. They say
Finally, a truly dynamic approach to the treatment of idiopathic scoliosis
Now, imitation is a form of flatery, and I dont know just how similar this is to the SpineCor, but I thought it interesting that they would be exploring new options like this.

FixScoliosis
01-18-2009, 08:47 AM
Hi concerned dad

you are not looking for a journal but a book.

publisher
http://www.hanleyandbelfus.com/

hope it helps

concerned dad
01-22-2009, 04:52 PM
Well, we’re back from our trip to Montreal. My daughter was fitted with the SpineCor and her in brace curve reduced from 38 to 27. Of course we hope to see a continued decrease in the curve as therapy progresses but only time will tell.

I was very impressed with Drs Rivard and Coillard. They struck me as people who love what they do and who have a sincere desire to help children. Dr Rivard met us in the lobby of the hospital and helped us through the registration and paperwork issues – we would have been lost without him as everything is in French. The brace really is quite the contraption with a seemingly infinite number of configurations of straps and grommets to treat specific types of curves. I can see why significant training would be required to effectively fit the brace to individual curves.

I’d like to get back to looking at the papers if anyone is interested.
Thanks for the reference Fixscoliosis. Unfortunately I cant get online access to books however I did request a copy of the article from the bostonbrace website. They had a link where presumably patients could request a copy of some pertinent literature. It’s been a week today so I better not hold my breath.

And Sharon, thanks for the reference to the “first” study performed in accordance with the SRS criteria. It’s funny, they (Janicki) do indeed note that theirs is the “first” in the text of the paper and I suppose it is true having beaten Coillard out by a few pages.

But that is the paper I thought we could talk about. Finally we have something to compare.

I guess the best way to look at it is to use the SRS reporting Criteria. Both abstracts are pretty clear on the details.

1A. percent of patients who have 5 degrees or less of curve progression
SpineCor 60%
TSLO 15%
Providence 31%

1B. Percent of patients who progressed by 6 degrees or more
SpineCor 10%
TSLO 85%
Providence 69%

2. Progression to surgery
SpineCor 23%
TSLO 79%
Providence 69%

3. Progression beyond 45 degrees
SpineCor 23%
TSLO 56%
Providence 45%

4. 2 year follow up
Janicki didn’t provide 2 year data

The average initial curve was 33.6 for Janicki and 32 for Coillard.

So, it looks like Janicki had some pretty horrendous results. It’s no wonder his conclusion was that a random controlled study should be performed. But, is it just me, or is the comparison between the results from the different braces dramatic. 79% of the TSLO group required surgery? Did I read that right? How can that be?

Anyway, I’ve been wrestling with the controlled random study issue. Rivard and Coillard clearly believe their brace is effective and superior. A comparison using the SRS Criteria above demonstrates this. Early on in their work they (Rivard et al) started a RCT but abandoned it. The current BrAIST trial will mean nothing about the efficacy of the SpineCor. Do we need a RCT (random controlled trial) to prove its efficacy?

Consider this:
If we have two diets A and B. If the folks on Diet A loose 10 pounds and the folks on Diet B loose 30 pounds, can we say that Diet B is better than Diet A? Perhaps yes if the studies are well done. But the relevant question is, Does the fact the Diet B is better than Diet A mean that dieting in general helps you loose weight? In the world of evidence based medicine, is that a valid conclusion? I don’t know but I bet Sharon is going to point me in the right direction.

BellasMom
01-22-2009, 05:03 PM
Concerned Dad;

How is your daughter adjusting to the brace?

Susie*Bee
01-22-2009, 05:05 PM
Another thought... which maybe you've addressed elsewhere, but this is not an experiment done in a laboratory, so the data isn't verifiable (or at least that's how it seems to me) based on the control aspects. How do they know whether the kids were compliant or not with wearing their braces, regardless of the type? Or is that built in to their data? It made me think of that when you mentioned diets, as that is another area where it's hard to compare results as some of the dieters may not have stuck to it very well.

BTW -- it sounds like your visit to Montreal was very productive. Best wishes with reducing your daughter's curve! :)

bscoli
01-22-2009, 06:54 PM
I recently saw this and thought it may be pertinent to this and/or other bracing discusisons:
The relationship between quality of life and compliance to a brace protocol in adolescents with idiopathic scoliosis: A comparative study.
http://www.biomedcentral.com/1471-2474/10/5

Pooka1
01-22-2009, 07:01 PM
I'm guessing many folks are glad to see you back and posting. I had some interesting exchanges with Ti Ed, among others, about tortoises and clams, inter alia. I wasn't bored but I'm happy to get back to bracing. :D


Well, we’re back from our trip to Montreal. My daughter was fitted with the SpineCor and her in brace curve reduced from 38 to 27. Of course we hope to see a continued decrease in the curve as therapy progresses but only time will tell.

Let's keep our fingers crossed that it works well.

(snip)


And Sharon, thanks for the reference to the “first” study performed in accordance with the SRS criteria. It’s funny, they (Janicki) do indeed note that theirs is the “first” in the text of the paper and I suppose it is true having beaten Coillard out by a few pages.

Ah, sorry. That was tongue in cheek. I consider those papers to have been published simultaneously; One does not precede the other.


But that is the paper I thought we could talk about. Finally we have something to compare.

I guess the best way to look at it is to use the SRS reporting Criteria. Both abstracts are pretty clear on the details.

(snip comparison stats)

I continue to have questions about how long the Spinecor patients have been out of brace for those data.

And I don't see any merit whatsoever in the stats on having had surgery. Again, there are people just in this little sand box with two progressive curves over 60* who don't have surgery and some with a single curve in the 40*s who are in the chute for surgery. Need I say more on this subject? If so, please advise.


So, it looks like Janicki had some pretty horrendous results. It’s no wonder his conclusion was that a random controlled study should be performed. But, is it just me, or is the comparison between the results from the different braces dramatic. 79% of the TSLO group required surgery? Did I read that right? How can that be?

Please see comment above.


Anyway, I’ve been wrestling with the controlled random study issue. Rivard and Coillard clearly believe their brace is effective and superior. A comparison using the SRS Criteria above demonstrates this. Early on in their work they (Rivard et al) started a RCT but abandoned it. The current BrAIST trial will mean nothing about the efficacy of the SpineCor. Do we need a RCT (random controlled trial) to prove its efficacy?

I think I'm on record with my thoughts on this. :)


Consider this:
If we have two diets A and B. If the folks on Diet A loose 10 pounds and the folks on Diet B loose 30 pounds, can we say that Diet B is better than Diet A? Perhaps yes if the studies are well done. But the relevant question is, Does the fact the Diet B is better than Diet A mean that dieting in general helps you loose weight? In the world of evidence based medicine, is that a valid conclusion? I don’t know but I bet Sharon is going to point me in the right direction.

You know my thoughts.

Pooka1
01-22-2009, 07:39 PM
I don't know what it is. Concerned Dad has made some excellent points. I have added some general comments on approach.

What is of interest to me is the lack of consensus among the orthopedic surgeons out there who have dealt with braces for years.

I remain convinced the various non-fusion surgical techniques will soon overcome any limitations and become the standard of treatment over and above any external bracing.

Pooka1
01-22-2009, 08:01 PM
Another thought... which maybe you've addressed elsewhere, but this is not an experiment done in a laboratory, so the data isn't verifiable (or at least that's how it seems to me) based on the control aspects. How do they know whether the kids were compliant or not with wearing their braces, regardless of the type? Or is that built in to their data? It made me think of that when you mentioned diets, as that is another area where it's hard to compare results as some of the dieters may not have stuck to it very well.


As I understand it, the suggested approach to dealing with compliance is to report "intent to treat." That is, the hope is that the average compliance rate, whatever it is, will be constant from large group to large group. If so, then the overall success of the brace will reflect the average compliance.

Now it may be that the success would actually be measurably higher if they had 100% compliance. But that is really irrelevant if the actual compliance is never going to be 100%. I suspect some braces are so hard to wear that even if you could show a higher success rate with higher compliance, you still would have non-compliant patients, at least in the AIS crowd. The stakes are higher in the JIS crowd where fusion surgery isn't an option and it might matter there.

Just my thoughts. Could be wrong.

concerned dad
01-23-2009, 11:37 AM
Bellasmom, She is doing just great in the brace. I'll post and comment more on this in the SpineCor thread as I do have some questions for the folks familiar with the brace.

Susie*Bee, yes the compliance thing is important. I understand the new Braist study includes sensors in the braces to be able to actually measure compliance rather than relying on the parents or patients. I think you are exactly right about how it also relates to the diet analogy. There is an interesting link I'll share below relative to this.

Bscoli, thanks for the link. I dont know how much credance I can put to a study like that. It seems that one factor they didnt consider or account for was the effect of different curves. They seem to claim that poor compliance equates to poor QOL scores and that social conseling could improve compliance. But, how to account for someone who has a high curve and perhaps a brace that is aggressive and experiences pain. That patient may be less likely to be compliant and, because she wears the brace part time, still experiences significant discomfort. She would have a low QOL score and a low compliance score but I would suggest they may be related.

Sharon,
regarding the intent to treat analysis, there is a very good webpage and discussion about this.
intent to treat analysis (http://www.jerrydallal.com/LHSP/itt.htm)
he makes the provocative case that intent to treat is a fraud.
Later down the page he seems to make an exception for the fraud anology when it comes to the issue of compliance.

he also has a section on study design that is very interesting and informative.

study design (http://www.jerrydallal.com/LHSP/STUDY.HTM)

regarding
What is of interest to me is the lack of consensus among the orthopedic surgeons out there who have dealt with braces for years.

that is of interest to me as well. It doesnt make sense to me. I feel like I am missing something important. When we see these two studies come out in the same journal with strikingly different results I would think that the response would be to use the SpineCor more rather than start a RCT. Or, at the very least, include the SpineCor in the RCT. We have an appointment coming up with a physician participating in the BrAIST study. He is in my insurance network. He is a member of the SRS and well published. I may put the question to him.

Pooka1
01-23-2009, 12:04 PM
Those are good web sites that go far in explaining how hard it is to design a worthwhile study. I believe it is also easy to see why many/most published studies are false given how hard it is to do a good study.

Lots of things are tough nuts to crack. Bracing appears to be one of them.

concerned dad
01-23-2009, 12:17 PM
I thought you would like those web pages. I had to do a double take to be sure it wasnt your webpage.

Pooka1
01-23-2009, 12:37 PM
Oh you can bet dollars to donuts that wouldn't be any web page of mine!

While there are some parallels to other fields of science, the medical trials have their own set of design issues. (ETA: You will NEVER catch me doing any science where groups of people are under study! I like the kind of work where I'm in lab or on a research vessel and my cohorts throw food under the door for me. :D)

Beyond that, I'm of the firm opinion that if you need fancy statistics to interpret your data, you need a better study design.

I'm really glad you found and posted those. They give a sense of how hard it is to get real answers. And there are other issues besides those.

So although science is really the only way of knowing anything, there are no guarantees that it has to be simple, Occam's Razor aside. :D

Pooka1
01-23-2009, 02:05 PM
(snip) When we see these two studies come out in the same journal with strikingly different results I would think that the response would be to use the SpineCor more rather than start a RCT. Or, at the very least, include the SpineCor in the RCT.

I can tell you that at least one surgeon views Spinecor results published by the Spinecor people with the thought that there is a high chance of bias. He may have meant unconscious bias.

The strikingly poorer Spinecor results obtained by the putatively unbiased researcher in Hong Kong are consistent with this. Plus, I don't know how convincing surgeons find the Spinecor response to the Hong Kong study. They might be unpersuaded that the Hong Kong study was so fatally flawed, I don't know. I have read the response and I find it a tough call.

An even bigger hurdle for Spinecor IMO is convincing folks the patients are not wearing the brace when they shouldn't be after treatment. I think we can start to get some idea of whether or not this is happening if/when Coillard/Rivard start publishing the stats on percentages of patients who fail at least one trial weaning, how many weaning periods patients typically need, and how they know the patients are not wearing the braces more than instructed.

It's a compliance problem but of the opposite type as of the hard bracing except there is little incentive to get a handle on it by the researchers because any non-compliance will likely go towards painting a rosier picture of the success of the brace. Tough position to be in.

concerned dad
01-24-2009, 11:39 AM
You prompted me to have another look at the Wong paper.

Not only did they have poor results with the SpineCor but they had phenomenal results with the Boston Brace - a 95% success rate. (With success defined as curve progression of less than 5 degrees). Compare this to, oh, say, the Janicki paper we were just discussing above where they had a 15% success rate using the same criteria and brace.

And, I am guessing most folks are familiar with the other criticisms of the Wong paper where they show a photo of a patient in the SpineCor brace incorrectly applied. (And the assertion that the Wong researchers weren’t trained nor were they ever provided enough bracing components to treat the number of patients they report in their study).

So, I guess I have to take the Wong paper with a grain of salt. It is a data point, but just how meaningful it is is questionable.

That’s not to say we cant learn something from it. Wong, in his discussion, says

“Since SpineCor is a relatively new method for AIS, its efficacy is still controversial.11–13”

Hmmm, references 11 to 13. Lets see what they are all about.
References 11 and 13 refer to two Coillard papers which we have already discussed. What about reference 12.

12. Weiss HR, Weiss GM. Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): A prospective trail comparing two different concepts. Pediatr Rehabil 2005;8:199–206.

Weiss? That’s a name I’ve seen before on these forums. Here is the abstract:

Study design: Prospective comparison of the survival rates of two different bracing concepts with respect to curve progression and duration of treatment during pubertal growth spurt in two cohorts of patients followed up prospectively.

Objectives: To determine whether the results obtained by the use of a soft brace (SpineCor) is comparable to the results of the Cheneau derived TLSO during pubertal growth spurt.

Background data: In recent peer reviewed literature, the SpineCor is described as an effective method of treatment for patients with scoliosis. However, until now, no controlled study has been presented comparing the results obtained with this soft brace to a sample treated with other bracing concepts proven effective.

Methods: Twelve patients with Cobb angles between 16-32° during pubertal growth spurt are presented as a case series treated with the SpineCor. The survival rate of this sample is described and compared to a matched group of patients treated with the Cheneau brace of the same age group. All girls treated in both studies were pre-menarchial with the first clinical signs of maturation (Tanner 1-3).

Results: During the pubertal growth spurt, most of the patients (11/12) with SpineCor progressed clinicly and radiologicly as well (at least 5°). Progression could be stopped changing SpineCor to the Cheneau brace in most of the samples described (7/10). The avarage Cobb angle at the start of treatment with the SpineCor was 21.3°, after an avarage observation time of 21.5 months, 31°.

The control sample, primarily treated with the Cheneau brace (n = 15), showed at average no progression. Cobb angle at the start of treatment was 33.7° and after the observation time of 37 months, 33.9°. Radiological improvements can be reported for some of the cases (3/15) as well as progressions (3/15). At 24 months of treatment time, 73% of the patients with a Cheneau brace and 33% of the patients with the SpineCor where still under treatment with their original bracing concept, at 42 month follow-up time 80% of the patients with Cheneau braces and 8% of the patients with the SpineCor survived with respect to curvature progression. The differences of the proportions statisticly where highly significant.

Conclusions: The SpineCor does not change natural history of idiopathic scoliosis during the pubertal growth spurt. The use of the Cheneau brace seems to do so. Oncoming studies with the aim to test the efficiency of braces should be based on samples at immediate risk for progression (only girls with first signs of maturation but pre-menarchial).


OK, is it fair to say that this is it? Wong says the SpineCor is controversial and cites Weiss as the only opposing study to Coillard. Granted, I’m counting on Wong to have done a literature search for me digging up the dirt on the SpineCor and perhaps he missed something. But, correct me if I am wrong. Isnt Weiss the guy you (Sharon) were discussing with Quackwatch (http://www.scoliosis.org/forum/showthread.php?t=8179)?

:eek:

Pooka1
01-24-2009, 01:13 PM
As the consultant for Quackwatch has pointed out, there are counter-factual statements in some of Weiss' pubs. I have to believe these are not peer-reviewed publications because I don't like thinking that could get through peer-review.

I sent my analysis of the Weiss pubs to Quackwatch and there was considerable agreement on the points I made. Mainly, there is a strong "Look at the Wookie" aspect of Weiss's publications. That is, Weiss is trying to point out weaknesses, real and imagined, in other approaches as opposed to publishing positive evidence in favor of Schroth/Cheneau. What little he has published by way of positive evidence for Schroth/Cheneau is not persuasive by a long shot for several reasons.

I expect Schroth might soon be listed on Quackwatch. I further expect the Clear Institute to be the next poster child based on the quacky claims they make in print. :D

The tactic of falsely attacking other modalities like surgery is a red flag... it is the IDENTICAL tactic young earth creationists use in trying to defend the counterfactual position that the earth is a few thousand years old. They largely attack, ineptly, the fact of evolution and the fact of radio-isotopic dating techniques rather than put forth positive evidence ruling out that the earth is old. The reason they have to do this is because the earth is in fact a few billion years old, evolution can be shown to be a fact (both from fossil and molecular evidence) and creationists have emotional reasons for denying these facts, not scientific ones.

When you take your playbook from the young-earth creationists, you know (or should know) you're in trouble.

concerned dad
01-24-2009, 02:24 PM
You wont get any argument from me wrt the young earth creationists stuff, that's for sure.

But going back to the comment you made about why orthopedic doctors arent using the SpineCor..... If we look at the 'damning' evidence so far we have the Wong study and the Weiss study. I guess there is another point I wanted to make about Wong.

Wong reported the SpineCor had a 68% success rate. Coillard reported only a 60% success rate in her 2007 paper. The difference is, I think, that Coillard used "Intent to Treat" analysis (as suggested by the 2005 SRS paper) and thus included patients who dropped out for one reason of the other. I am not sure yet if Wong did this or not.

So, in essence, Wong may have shown even better success than Coillard. Or, at least comparable. The issue is, they (Wong) claimed the Boston Brace was far superior with a 95% success rate. (And, since they 'randomly' assigned braces the comparison is supposed to carry more weight - even though their sample size was small (N=22)).

I should note that the new 2008 Coillard paper which includes more patients (N=349), the "success rate" was 74.2%. (N=170 for the older 2007 Coillard paper).

But what's missing? Why isnt the SpineCor embraced by the US orthopedic community? I think I have a clue, hold on while I dig up a link.

Pooka1
01-24-2009, 02:56 PM
You wont get any argument from me wrt the young earth creationists stuff, that's for sure.

Everyone is entitled to their own opinions. They are NOT entitled to their own facts. Young earth creationists and Intelligent Design Creationists continue to struggle with this concept.


But going back to the comment you made about why orthopedic doctors aren't using the SpineCor..... If we look at the 'damning' evidence so far we have the Wong study and the Weiss study. I guess there is another point I wanted to make about Wong.

I don't consider the Wong study as being damning of Spinecor. IIRC, it suffers from some of the same problems we have been discussing. Spinecor might be effective.


Wong reported the SpineCor had a 68% success rate. Coillard reported only a 60% success rate in her 2007 paper. The difference is, I think, that Coillard used "Intent to Treat" analysis (as suggested by the 2005 SRS paper) and thus included patients who dropped out for one reason of the other. I am not sure yet if Wong did this or not.

So, in essence, Wong may have shown even better success than Coillard. Or, at least comparable. The issue is, they (Wong) claimed the Boston Brace was far superior with a 95% success rate. (And, since they 'randomly' assigned braces the comparison is supposed to carry more weight - even though their sample size was small (N=22)).

Ninety-five percent success rate reminds me of my orthotist who claims that only 2 of a few hundred kids he braced ever went on to surgery. Well even including my kid who is likely going to be (at least) number 3, That is simply ridiculous, as is the 95% success rate reported for the Boston brace in Wong. If that were true, all the orthopedic surgeons would be using it. That's how we can know independently there is something very wrong with that study.


I should note that the new 2008 Coillard paper which includes more patients (N=349), the "success rate" was 74.2%. (N=170 for the older 2007 Coillard paper).

But what's missing? Why isnt the SpineCor embraced by the US orthopedic community? I think I have a clue, hold on while I dig up a link.

Is the 2008 paper posted somewhere public?

concerned dad
01-24-2009, 03:04 PM
We are all subject to Bias. Having made the decision to go with the SpineCor I am likely biased now. The trick is to recognize bias and account for it with good study design.
We would be foolish to think that orthopedic surgeons are not subject to bias too. I would submit that perhaps they are biased against the SpineCor because of the prevalence of chiropractors offering it as a treatment here in the US. As evidence of the potential bias I offer a couple of comments from the SRS website (buried deep on their website I might add). This is from an annotated bibliography put together by the SRS bracing commitee. I saw these a few weeks ago and wanted to share them with you (Sharon) because I though you would get a kick out of a few of their comments.
I'm not saying that the comments below are false, I just think that they hint at a bias. (Emphasis added is mine)

Chiropracty and Scoliosis:
Effects of chiropractic intervention on small scoliotic curves in younger subjects: a time-series cohort design. Lantz CA, Chen J. J Manipulative Physiol Ther 24:385-393, 2001.
These chiropractic authors report their negative results. These authors studied 42 patients age 6 to 12 years with curvatures between 6 and 25°. Each patients underwent a series of chiropractic full spine adjustment over a mean of 14.5 months. In addition, they also were given heel lifts, as well as postural lifestyle counseling and exercises, such as stretching on a chinning bar. No improvement in the curves was observed with this treatment. The authors concluded that chiropractic treatment does not improve scoliotic curves. An important study to quote when asked about the role of chiropractic intervention.

An inquiry into chiropractors’ intention to treat adolescent scoliosis: a telephone survey.
Feise, RJ. J Manipulative Physiol Ther 24:177-182, 2001.The author is Research Director, American Chiropractic Research Foundation. The findings exemplify the state of current chiropractic management of scoliosis. In this study 90% (114/216) of an eligible sample of chiropractors responded to a telephone survey to determine the clinical management approach to a hypothetical 12 year old, Risser 1, female patient with a 25° curvature of the spine. It was found that the typical chiropractor would provide 6 months of intensive adjustive treatment and 4 years of follow-up care, 73% would use heel lifts, 87% exercise, and 39% physical therapy or electrical stimulation (30%). Ninety-five percent stated that they used clinical experience as a means of establishing a treatment regimen. Only 20% knew the difference between retrospective and prospective research design.

I know you'll enjoy the last bolded text item. It doesnt prove my point but I just had to include it. :D

I guess my point is, after reading the above, how likely would it be that an orthopedic surgeon would refer a patient to a chiropractor to get a SPineCor brace? Now, of course, we realize that the chiropractors offering the SpineCor arent offering it as a 'traditional' chiropratic treatment (and the papers above are indeed relating to 'traditional' treatments).

Pooka1
01-24-2009, 03:14 PM
Very amusing!

In re the presumably low likelihood of surgeons referring patients to chiros for Spinecor, I think that will be confounded by the number of surgeons who won't refer any patients for any type of brace.

There is a reason mainstream folks are skeptical of chiro. Not all chiro is woo-woo but much of it is.

concerned dad
01-25-2009, 11:21 AM
OK, maybe not the best paper (understatement), but here is a recently published (last week) abstract by a presumably independent SpineCor researcher.
Sosort Abstract from folks in Greece (http://www.scoliosisjournal.com/content/pdf/1748-7161-4-S1-O35.pdf)

I need to dig into this "outcome" thing. It may mean all the patients in the study are still being braced. Or, it may mean that none of the patients have hit the 2 year post brace mark. <scratching head>

But in either event, it shows markedly different results than Weiss (who had 11 out of 12 patients progress in the SpineCor brace).

Pooka1
01-25-2009, 11:34 AM
:D

I realize that conference abstracts usually have tightly controlled word counts but they really should define "outcome" when it is their major result (since they stated it first). Also, as you state, it is very likely critical to understanding all the other results.

In this case, though, I think no outcome simply means the "magic" two year period hasn't expired to report the results per the 2005 SRS criteria. It's only been about a year.

Still, they could fill the void with data on how many patients are being treated versus weaned, etc.

jillw
01-25-2009, 11:41 AM
Concerned dad, you are right aht they are still being braced because the opening statement said that they looked at patients that were still being actively treated - therefore the results aren't really that relevent, yet...hopefully they'll follow up in a few years as some of those patients reach maturity and post back to us.

Pooka1
01-25-2009, 11:57 AM
I missed that.

So you are saying these are all "in brace" data?

That is not publishable in my opinion. By a LOOOOOOOOONG shot.

mariaf
01-25-2009, 12:04 PM
I could not agree more with Sharon if in fact they are talking about "in brace" data. To me, it would seem premature to consider what "results" have been achieved if the treatment (i.e., bracing) is still ongoing.

Pooka1
01-25-2009, 12:06 PM
I'm having another Candid Camera moment...

:D

CAmomof2
01-25-2009, 12:31 PM
The tactic of falsely attacking other modalities like surgery is a red flag... it is the IDENTICAL tactic young earth creationists use in trying to defend the counterfactual position that the earth is a few thousand years old. They largely attack, ineptly, the fact of evolution and the fact of radio-isotopic dating techniques rather than put forth positive evidence ruling out that the earth is old. The reason they have to do this is because the earth is in fact a few billion years old, evolution can be shown to be a fact (both from fossil and molecular evidence) and creationists have emotional reasons for denying these facts, not scientific ones.

When you take your playbook from the young-earth creationists, you know (or should know) you're in trouble.


Pooka,
Your above comment bothers me - I do believe in creation, yet I do NOT think that the earth is just a few thousand yrs old. The planet’s coming into existence is recounted in the Bible with the simple statement: “In the beginning God created the heavens and the earth.” (Ge 1:1) Just how long ago the starry heavens and the earth were created is not stated in the Bible. Therefore, there is no basis for Bible scholars to take issue with scientific calculations of the age of the planet. Scientists estimate the age of some rocks as being three and a half billion years, and the earth itself as being about four to four and a half billion or more years.
I'm not sure if this is what you meant - I just wanted to clarify this point. Sorry to others as this has nothing to do with scoliosis. Now... back to the program......:)

Pooka1
01-25-2009, 12:44 PM
I make every and all efforts to always use the term, "young earth creationist" to distinguish the counterfactual claims of a young earth with the unfalsifiable claim of "creation."

Young earth creationism is falsifiable and has been falsified a bazillion different ways for decades and decades. It is a demonstrable fact that the earth is a few billion years old and evolution is a fact.

I do realize rational folks use the term "creationist" to mean a non-literal rendition of biblical creation but not young earth creationism. That's fine but I just think they are running the risk of getting mixed up with the young-earth creationist crowd and should use a different term for their own sake.

If I used "creationist" instead of "young earth creationist," I was being sloppy and I apologize. "Creationism" distinct from "young earth creationism" is not falsifiable. It might be correct. But there is no evidence to date for the claim.

leahdragonfly
01-25-2009, 01:14 PM
Hi Guys,

This is an interesting thread about bracing research, but can we PLEASE stick to the topic of scoliosis, and not get into the topic of personal religious beliefs etc. There was another long and contentious thread here some months ago about religion and creationism and we don't need to rehash it. Everyone gets to believe in what they believe in, and we should only be discussing scoliosis here.

Thank you.

concerned dad
01-25-2009, 01:53 PM
Yes, there is a world of difference between the belief that God created the universe and the belief in the so called "science" of "Young Earth" Creationism.

Sharon was using it as a good example of a deceptive technique of arguing againt a point. And it is a good example of what she was trying to show. Perhaps there are others though as well because it can easily be misconstrued (Especially if you forget to add the words "Young Earth" and if people arent familiar with the notion that it is promoted as a science rather than a belief)

Going back to my diet example, it is as though Weiss was trying to show his diet was better then the SpineCor diet by pointing out the weakness of the SpineCor diet without demonstrating the effectiveness of his diet.

Hmmmm, not sure if that one worked. Weiss didnt do that here, he does it when he promotes Schroth over surgery. But I think Sharon's point was that this deceptive way of arguing is in his 'playbook".

And, for someone like myself who is now admitidly biased FOR the SpineCor, I am happy to see this Weiss paper discredited by way of discrediting Weiss. (Although to be honest, it is still a data point in the back of my mind).

But, regarding the "Candid Camera" thing.
Lets read between the lines a bit.

Weiss presents a paper where he says 11 out of 12 of his patients treated with the SpineCor failed during brace treatment. This Greece presentation, contradicts Weiss's claims, regardless of whether or not the folks are still wearing the brace.

This further discredits the Weiss study. Perhaps that was the whole point of the presentation.

And, they (the Greek folks) say, in their title, that this is a preliminary report.

Pooka1
01-25-2009, 02:47 PM
(snip)But I think Sharon's point was that this deceptive way of arguing is in his 'playbook".

It is the fallacy of the false dichotomy. It is the attempt to claim overtly or subliminally that there are only two alternatives and if they can sufficiently attack one, then the other is left as the only possible "correct" answer.

It is obvious that this is the ONLY way to argue when there is no positive evidence in favor of one's position as is the case for young earth creationism and little positive evidence in favor in the case of Schroth.

CAmomof2
01-25-2009, 04:15 PM
Pooka,
Excuse my ignorance - like I said I wasn't sure what you meant.

Pooka1
01-25-2009, 05:40 PM
Pooka,
Excuse my ignorance - like I said I wasn't sure what you meant.

Ignorance?

You cleared up an important point.

concerned dad
01-26-2009, 04:00 PM
Just when I thought I was ready to accept that the jury was still out I find this
Backtalk - April 1999 (http://www.scoliosis-assoc.org/default.tpl?PageID=58&cart=12329801387548896&PageName=NON-SURGICAL%20MANAGEMENT&sec_id=58&sec_status=main)

I probably wouldnt have posted it here except the author (Winter) speaks with such conviction. (Emphasis added is mine)

regarding Lonstein
"showed with absolute statistical clarity that bracing did alter the natural history"

and regarding Nachemson

"This study also showed, with absolute statistical clarity, that bracing did have a positive effect on the natural history,..."

and the Puerto Rico Study...
"Once again, bracing was shown to have a positive effect, with the non-braced group having three times the failure rate compared to the brace treated group. "

and Finally stating

"These three studies, all high-quality clinical research, answered the question with finality. Yes, bracing can have a positive effect on adolescent idiopathic scoliosis, particularly for progressive curves in growing children between 20° and 40°. "

Well, that's not too wishy washy. This fellow is convinced.

Pooka1
01-26-2009, 04:28 PM
Just when I thought I was ready to accept that the jury was still out I find this
Backtalk - April 1999 (http://www.scoliosis-assoc.org/default.tpl?PageID=58&cart=12329801387548896&PageName=NON-SURGICAL%20MANAGEMENT&sec_id=58&sec_status=main)

I probably wouldnt have posted it here except the author (Winter) speaks with such conviction. (Emphasis added is mine)

regarding Lonstein
"showed with absolute statistical clarity that bracing did alter the natural history"

Winter is the coauthor on this paper. Of course he thinks the paper is marked by clarity and conviction. Essentially, he is patting himself on the back. In public. Some would say that is unseemly. Me, I think the guy just thinks he did a bang-up job. :D


and regarding Nachemson

"This study also showed, with absolute statistical clarity, that bracing did have a positive effect on the natural history,..."

This Nachemson and Peterson paper has real problems, some of which we discussed. Winter likes it because it supports his general position.


and the Puerto Rico Study...
"Once again, bracing was shown to have a positive effect, with the non-braced group having three times the failure rate compared to the brace treated group. "

Same comment as for the Nachemson and Peterson paper.


and Finally stating

"These three studies, all high-quality clinical research, answered the question with finality. Yes, bracing can have a positive effect on adolescent idiopathic scoliosis, particularly for progressive curves in growing children between 20° and 40°. "

Well, that's not too wishy washy. This fellow is convinced.


He certainly is convinced; I'll give you that. :)

Mary jane
01-27-2009, 08:32 PM
My daugher is 17 now and is scheduled for surgery. She had the Spinecor brace for 2 years, but her curve was so bad before we ever found the Spinecor site. She basically used the brace for support to put off surgery, but I think if we would have started the this program brace when we first got a brace it would have helped. My daughter has something called Dysautonomia and because of that she could not wear her Boston brace or the Milwaukee brace that she had made for her when she was 12 and 14. They were too painful and restricted her digestive system. But we did not find the Spinecor system until she was almost 15. I think it would help as much as anything else out there.

Pooka1
01-27-2009, 09:04 PM
My daugher is 17 now and is scheduled for surgery. She had the Spinecor brace for 2 years, but her curve was so bad before we ever found the Spinecor site. She basically used the brace for support to put off surgery, but I think if we would have started the this program brace when we first got a brace it would have helped. My daughter has something called Dysautonomia and because of that she could not wear her Boston brace or the Milwaukee brace that she had made for her when she was 12 and 14. They were too painful and restricted her digestive system. But we did not find the Spinecor system until she was almost 15. I think it would help as much as anything else out there.

You might be right about the brace.

I had to look up dysautonomia.

I saw a medical show ("Mystery Diagnosis" or something like that) where a woman was eventually diagnosed with POTS which I see is related to dysautonomia. It was amazing that they finally found a doctor who knew what the heck that woman had! She might not have as it seems to be quite rare.

In re the brace helping, I gather bracing is known to fail with certain connective tissue disorders including Marfan's though I don't know about dysautonomia.

It could be that undiagnosed cases of these conditions skew the success rate of bracing towards less positive percentages. That is just one of several possible confounders in the brace literature in my opinion. If it could be cleaned up, we might see some proof that bracing works, at least for some kids. It might work.

FixScoliosis
01-28-2009, 09:02 AM
Regarding progression despite bracing, maybe there are differences in the spines and their configuration/alignment themselves that predispose some to progress more than others. I'm currently reading a paper for my blog that has studied this and it seems to have some interesting insight to share. I’ll get back once I have worked my way through it.

concerned dad
01-28-2009, 04:00 PM
FOR SALE – One slightly USED SpineCor Brace

Not really, :D I was going to post this as a separate thread thinking that it just might raise some eyebrows and get more folks interested in participating in this discussion, then I thought perhaps the moderators might not appreciate the humor.

We just had an appointment with another local (relatively – compared to Montreal) Orthopedic Surgeon. We had still needed to follow up on the MRI recommendation of the first guy we saw.

I made this appointment in early December when we decided not to stay with the first orthopedic guy and we were weighing our options. One of my concerns was the discordance between my daughters Risser 0 and her age and post menarchal status. In my first post at the top of this thread I said that I thought that based on her high curve and low Risser score I figured (based on what little I could glean from the research) that she had a high likelihood of curve progression. I found recent research showing that Risser may not necessarily be as good an indicator of skeletal maturity (and thus curve progression) as some other measures. The fellow we just saw did several studies looking at Tanner Whitehouse Staging and the relationship with IAS curve behavior. As I understand it, Risser is a convenient measure, but not the best. It is convenient because you can measure it with the same xrays as you typically take to assess scoliotic curves.

Anyway, my daughters DSA score from the Tanner Whitehouse scale indicates she is Stage 5. (This scoring looks at a hand xray to assess skeletal maturity) That seems to have quite a bit different prognosis than a high curve and Risser 0. Unfortunately this fellows study was limited statistically by a low number of patients. Never the less, it causes me to pause and rethink the logic of bracing in our particular circumstance.

I have been haunted (not sure if that is the right word, perhaps motivated is better) by a statement Sharon made earlier where she basically questioned if it is ethical to brace a child if we DO NOT know it will help. (This was in response to me questioning the ethics of a random study) So now I find myself wondering if there is much of a risk of curve progression now that I have a different view of her skeletal maturity. I mean, if she were say 18 years old, we wouldn’t be bracing her because she was clearly done growing. Risser 0 suggests MUCH more growth but DSA Stage 5 (and her height, age and post menarchal status) indicates much of her growth has already occurred.

I guess I am less of a Concerned Dad now. We are weighing our options now in light of the new information.

By the way, this fellow we saw was really good. Wonderful with my daughter, really knew his stuff, SRS member, very well published – particularly as it relates to my daughters specific issues, is participating in the Braist Study, very familiar with the SpineCor and…… IN NETWORK for my insurance. He spent almost 1.5 hours discussing this with us. You don’t find many physicians willing to devote that much attention. I don’t want to say publicly WHO he is because I want to discuss some of the things he said, and the chance of me (unintentionally) misquoting him is high enough that I wouldn’t want to put words in his mouth (remember, everything you read on these forums should be taken with a grain of salt). Of course, a Google or a PM would likely get you a name.

RugbyLaura
01-28-2009, 04:49 PM
...I don’t want to say publicly WHO he is because I want to discuss some of the things he said...

Looking forward to it!

Laura

Pooka1
01-28-2009, 05:39 PM
I found recent research showing that Risser may not necessarily be as good an indicator of skeletal maturity (and thus curve progression) as some other measures. The fellow we just saw did several studies looking at Tanner Whitehouse Staging and the relationship with IAS curve behavior. As I understand it, Risser is a convenient measure, but not the best. It is convenient because you can measure it with the same xrays as you typically take to assess scoliotic curves.

Anyway, my daughters DSA score from the Tanner Whitehouse scale indicates she is Stage 5. (This scoring looks at a hand xray to assess skeletal maturity) That seems to have quite a bit different prognosis than a high curve and Risser 0. Unfortunately this fellows study was limited statistically by a low number of patients.

Yes I came across some info which I posted a while back indicating the Whitehouse Tanner or Tanner Whitehouse and some Roman numeral IIRC was the best indicator of skeletal maturity but I didn't read the study. I'd like to hear what your surgeon says about the magnitude of the discordance.


(snip) I mean, if she were say 18 years old, we wouldn’t be bracing her because she was clearly done growing. Risser 0 suggests MUCH more growth but DSA Stage 5 (and her height, age and post menarchal status) indicates much of her growth has already occurred.

That's the correct way to think about it as far as I know. I'd like to know what the surgeon said.


I guess I am less of a Concerned Dad now. We are weighing our options now in light of the new information.

What do you want us to call you now? :D


By the way, this fellow we saw was really good. Wonderful with my daughter, really knew his stuff, SRS member, very well published – particularly as it relates to my daughters specific issues, is participating in the Braist Study, very familiar with the SpineCor and…… IN NETWORK for my insurance. He spent almost 1.5 hours discussing this with us. You don’t find many physicians willing to devote that much attention.

Have you considered he spent so much time with you because you are somewhat familiar with the bracing literature? Did you mention any of the points you have made here to him? What does he think about the bracing literature?


I don’t want to say publicly WHO he is because I want to discuss some of the things he said, and the chance of me (unintentionally) misquoting him is high enough that I wouldn’t want to put words in his mouth (remember, everything you read on these forums should be taken with a grain of salt). Of course, a Google or a PM would likely get you a name.

That's a very good point. I try to qualify statements that I relay from our surgeon. When he is absolutely clear, though, I just say it (like the 95% of kids who don't need physical restrictions after fusion who still will have no problems. It would have been hard, if not impossible, for me to miss that point.)

Very glad things are looking up for you, The Dad Formerly Known as Concerned (depicted by an unpronounceable symbol?) :D

Pooka1
01-28-2009, 08:10 PM
(snip)
I was going to post this as a separate thread thinking that it just might raise some eyebrows and get more folks interested in participating in this discussion,

I think the thread would be much more valuable if more folks would weigh in with their thoughts on the bracing literature.


then I thought perhaps the moderators might not appreciate the humor.

This place is effectively unmoderated IMHO.

concerned dad
01-29-2009, 12:50 PM
Before we get into any discussion of what a particular doctor says about the topic of bracing perhaps we should pause to remember something. We all put a lot of weight to what we are told by our physicians. But on the topic of bracing in AIS there is much debate in the medical community. While I was trying to understand the whole rational for the BrAIST study, I came across a paper from the folks in Iowa (they are the strong proponents of the BrAIST study). Anyway, the link to the abstract is here (http://ovidsp.tx.ovid.com/spb/ovidweb.cgi?T=JS&PAGE=fulltext&D=ovft&AN=01241398-200704000-00004&NEWS=N&CSC=Y&CHANNEL=PubMed) but if you’ll permit me, I’ll try to sum up what I think they are saying.

Apparently some physicians who were asked to participate on the BrAIST study declined on ethical grounds. One way to remove (or reduce) the ethical concerns would be to survey a bunch of specialists and see how much they agreed on the topic. If there was poor agreement (they used the word ‘equipoise’ - just to make me feel stupid and break open a dictionary:D) then ethical considerations would be diminished.

So, they sent a survey to a bunch of physicians who deal with AIS. They asked them to consider a bunch of scenarios of expected outcome for different curve amplitudes, menarchal status and curve type – for both braced and unbraced patients. For example, in one of the scenarios they asked for the doctors to predict outcome for a premenarchal girl with a thoracic curve greater than 35 degrees with and then without bracing. So, this would reflect that particular physicians opinion on what the outcome would be in that specific case.

So, what were the results? They sent out 423 surveys and received back 82 from doctors willing to participate in the survey. An interesting aside, they note that of those 82, four bozos (my word, not theirs) had bracing failure rates that were higher than observation failure rates for all scenarios – so they excluded these responses. Anyway, they didn’t further report on the 82 respondents except to say that since the response rate was so low, the analysis wouldn’t be too meaningful.

They then decided to create an expert panel of 29 of the most experienced of the 82 who responded. They looked at the responses to the scenarios from the 29 experts and concluded that they basically didn’t agree much on anything. (they did agree on something – see below). They used this disagreement of the experts to conclude that a state of ‘equipoise’ exists and a random bracing study was both ethical and called for. Fair enough.

OK, why did I want to share this? Two things; One – if we look hard enough it would be easy to find a doctor who would tell us whatever we wanted to hear about the matter. There is a lot of valid variation of opinion on bracing with the experts.

The second point though is that the experts agreed on ONE thing. (Actually several things but all related to menarchal status - This ‘agreement’ was not 100% but it was the strongest consensus of opinion). That is:

More than 80% of the experts indicated that bracing would have a small effect on postmenarcheal patients with thoracic curves (for both small and large curves), postmenarcheal patients with small thoracolumbar/lumbar curves, and postmenarcheal patients with small double major curves. The respondents were very close to agreement (77% and 79%) that bracing would have only a small effect on postmenarcheal patients with either large thoracolumbar/lumber curves or double major curves.

Since my daughter falls within this window of consensus, it is making me further question bracing in our particular circumstance. My problem is, I am not a big ‘consensus’ guy, I’d rather see real data.

As another aside, since they didn’t demonstrate equipoise on the menarchael issue, I thought it interesting that they omitted any discussion about why they are still enrolling post menarchael (1 yr) in the BrAIST study. (This goes to the question of, is it ethical to put a kid in a brace if you don’t think it would help as opposed to the question of withholding brace treatment in a kid where you do think it would help).

Am I boring you folks yet?

Pooka1
01-29-2009, 01:45 PM
(snip)
As another aside, since they didn’t demonstrate equipoise on the menarchael issue, I thought it interesting that they omitted any discussion about why they are still enrolling post menarchael (1 yr) in the BrAIST study. (This goes to the question of, is it ethical to put a kid in a brace if you don’t think it would help as opposed to the question of withholding brace treatment in a kid where you do think it would help).

Excellent point.

I suspect they want to include all potential confounders in the large study. It's still a fifth of the surgeons who apparently think the jury is out on bracing post menarche girls. And it may turn out that some portion of this population does respond to brace treatment so best not to exclude them completely from the study.

And to me, Equipoise will always be a champion thoroughbred who was also quite dreamy...

Equipoise (http://www.pedigreequery.com/photos/equipoise)

:)

concerned dad
01-30-2009, 09:36 AM
Sometimes (most times) I forget where I learn something.

I just reread this old post from Linda and that may be why we persued the assessment of skeletal maturity.


Hi Shebee...

You might want to see if you can get someone to evaluate your daughter's skeletal maturity, because if she has had her period, especially if she started a year or more ago, it's unlikely that the brace will be of much help.

Regards,
Linda

Thank you Linda. And Sharon, thank you as well because I think we discussed this someplace on another thread dealing with Risser issues.

Now, my daughters skeletal maturity assessment doesnt indicate she is completely done growing, just likely past her major growth spurt.

And, the fellow we spoke with mentioned that he felt the main problem with the 1995 Nachemson SRS study was not only the stratification of curve types, but the assessment point where they viewed a 6 degree increase as a failure (for both braced and non braced patients). He said (my paraphrasing), for example, a 20 degree curve going to 26 degrees out of brace isnt necessarily a bad thing. What would be more important would be to assess how many went on to surgery OR how many increased to a curve angle that is a proxy for surgery (ie 50 degrees).

What I find somewhat frustrating is why someone cant go back into the data and figure that out. Perhaps (I am not sure) in that study once a patient progressed 6 degrees they considered it a failure of observation and put the child in a brace. If that is the case then it would not be possible to salvage any data.

concerned dad
02-01-2009, 09:50 AM
Bingo! I found this buried on another thread. I knew someone had to at least attempt to salvage something from the "failed" SRS bracing study that took 10 years to complete and is apparently dismissed by so many physicians who now find it ethical to participate in the current BrAIST study.

I need to read this a second time, but it addresses the question of what happens if we forget about the 6 degree increase thing (which meant that observation was a failure and is a main critisism of the study) and look at surgery and progression of curves. After a first read, I can tell you the paper looks very interesting. I'm going to grab some celery sticks and have another run through it. Emphasis added below is mine.




Sorry, but I have to disagree. Why would reputable scoliosis surgeons continue to prescribe custom made TLSO braces for kids with curves between 20-40 degrees? If you believe the anti-surgery folks, these surgeons have a lot to gain by having patients who fall into the surgery parameters. Bracing is not a perfect option, but nothing is. When braces are used in the correct population, and manufactured correctly, they can be very effective:


Spine. 2007 Sep 15;32(20):2198-207.Click here to read Links
A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity.
Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL.

Department of Orthopedics, Sahlgrenska University Hospital, Göteborg, Sweden. danielsson.aina@telia.com

STUDY DESIGN: The Swedish patients included in the previous SRS brace study were invited to take part in a long-term follow-up. OBJECTIVE: To investigate the rate of scoliosis surgery and progression of curves from baseline as well as after maturity. SUMMARY OF BACKGROUND DATA: Brace treatment was shown to be superior to electrical muscle stimulation, as well as observation alone, in the original SRS brace study. Few other studies have shown that brace treatment is effective in the treatment of scoliosis. METHODS: Of 106 patients, 41 in Malmö (all Boston brace treatment) and 65 in Göteborg (observation alone as the intention to treat), 87% attended the follow-up, including radiography and chart review. All radiographs were (re)measured for curve size (Cobb method) by an unbiased examiner. Searching in the mandatory national database for performed surgery identified patients who had undergone surgery after maturity. RESULTS: The mean follow-up time was 16 years and the mean age at follow-up was 32 years The 2 treatment groups had equal curve size at inclusion. The curve size of patients who were treated with a brace from the start was reduced by 6 degrees during treatment, but the curve size returned to the same level during the follow-up period. No patients who were primarily braced went on to undergo surgery. In patients with observation alone as the intention to treat, 20% were braced during adolescence due to progression and another 10% underwent surgery. Seventy percent were only observed and increased by 6 degrees from inclusion until now. No patients underwent surgery after maturity. Progression was related to premenarchal status. CONCLUSION: The curves of patients with adolescent idiopathic scoliosis with a moderate or smaller size at maturity did not deteriorate beyond their original curve size at the 16-year follow-up. No patients treated primarily with a brace went on to undergo surgery, whereas 6 patients (10%) in the observation group required surgery during adolescence compared with none after maturity. Curve progression was related to immaturity.

Pooka1
02-01-2009, 10:16 AM
Some questions I have...

1. This is a subset of the larger group which we know stacked patients unevenly. This needs to be addressed in a non-cursory fashion at some point. Also, there is plenty else going on that limits drawing many robust conclusions besides that.

2. Have some of the patients got the surgery in some other country? If so, it wouldn't show up in the National surgery database.

3. In addition to stating who has and hasn't had surgery by 16 years out (average), I would like to know how many of those patients are above the 35*- 40* point which is still sub-surgical but can be expected to progress a degree a year and almost certainly require surgery at some point? For all we know, the same fraction in the braced and observation group will require surgery at some point.

My general comment is there are some ways to present the data that cut to the chase and some ways that don't. For example, it is obvious that Spinecor needs to present the percentage of patients who need one or more weaning periods and be very clear that anything represented as the "magic" two years post bracing is in fact that. Yet that goes unreported to date. Or just presenting the distribution of various types of curves in each study group. I think certain published studies would have been rejected for publication had these graphs been present.

It is odd to me that lay, untrained, no-account yahoos like myself can immediately see some apparently valuable ways to crunch the data that these seasoned researchers apparently have not. This is not my field and it could very well be I'm missing boatloads of material. Who knows. What I do know is this bracing literature is a miasma and plenty of surgeons agree with that.

On the other hand, this seems like a very intractable area of research so I'm not blaming the researchers for the lack of robust results. I think most of them are trying and operating in an intellectually honest manner. Some things are inherently hard to nail down and this seems like one of them.

concerned dad
02-01-2009, 12:07 PM
interesting excerpts from the paper
from
A Prospective Study of Brace Treatment Versus
Observation Alone in Adolescent Idiopathic Scoliosis
A Follow-up Mean of 16 Years After Maturity
Aina J. Danielsson, MD, PhD,* Ralph Hasserius, MD, PhD,† Acke Ohlin, MD, PhD,†
and Alf L. Nachemson, MD, PhD*

The main result of this long-term follow-up is that, if patients are located at an early stage by scoliosis screening and treatment is started early, 93% of the patients will have a curve size less than 45° and no patients will be operated on after maturity, regardless of whether they are treated with a brace or observation (My comment here for clarification, I think when the say observation, they mean observation for the first 6 degrees, then bracing). However, patientswho were braced from the start had a significantly smaller curve size, at the same level as at the time of detection.

and a very thought provoking observation/question

As 70% of the observed patients during the original study period did not require any other treatment, 70% of the initially braced patients can therefore be regarded as having been treated unnecessarily. One major question is as follows: is it worth overtreating such a high percentage of patients to realize the goal of “saving” only 10%
of the patients from surgery, the percentage in the group of observed patients?

and this answers some of the questions in Sharons post above

After a mean of 16 years after maturity and at a mean age of 32 years, the advantage of early bracing versus observation in patients with AIS and a curve size of 25° to 35° was seen during adolescence and not during the time after maturity. No patients in either group, bracing from inclusion or observation as the intended treatment, underwent surgery after maturity. Six patients (7%) had a curve size exceeding 45°, 1 in the initially braced group and 5 in the initially observed group (not significant),with none exceeding 48°. Patients braced from the start had a significantly smaller curve magnitude at follow-up, but the difference between the groups was within themeasurement error. Our present results do not change the principal conclusion of the original SRS study: that well-performed brace treatment prevents curve progression during adolescence in patients with moderate AIS, while observation as the intended treatment allowed 70% of patients to escape any treatment at all and left 10% with surgical treatment and 20% with brace treatment.

That last sentence is pretty interesting.

Pooka1
02-01-2009, 12:33 PM
It's my understanding that a large fraction, if not most, kids who emerge from adolescent with a curve that is larger than ~ 40* (I'll have to search for the correct number but this is close) will progress about one degree a year for the rest of their life. Not all but many if not most.

This is partly why I was opposed to bracing my one daughter (though she chose to try it). Even if it worked, and kept her at a sub-surgical angle after growth was done, she was likely looking at surgery in the future. So I viewed bracing her as potentially putting off the surgery rather than avoiding it. If her curve holds at 40*, no surgeon is going to touch her now and yet she is likely looking at surgery down the road. (N.B. I am in an unusual situation where I already know the outcome of my daughter's twin. I admit the situation wouldn't be as clear if there was no twin.)

Kids can be back to school in 25 days. Many adults aren't back to work even after in 25 weeks. Now that the hardware is curative in some cases, for me it is imperative my kid gets the surgery as a kid and NOT as an adult when she is working a career and when recovery is an order of magnitude harder. My daughter's brace is failing to hold her curve. That is looking like the best possible outcome at this point, all things considered.

FixScoliosis
02-01-2009, 01:58 PM
written in a paper I read recently.

"The degenerated
idiopathic scoliosis mostly in the lumbar and/or thoracolumbar
spine is quite frequently combined with
spinal stenosis at a relatively young age, specifically in
the adjacent lower segment after Harrington instrumentation.
This adjacent segmental spinal stenosis,
mostly below a long fused idiopathic scoliosis, appears
about 15–20 years post-surgical with Harrington rods
(Fig. 5). There are not yet similar long-term results
available for cases which have been treated with one
of the CD-type third generation instrumentation that
allow superior restoration of the sagittal alignment,
possibly protecting the spine from developing rapid
adjacent segment degeneration"

Hopefully the newer pedicle screw surgeries can avoid the rapid degeneration seen with harrington rods.

I know that they are studying increased G-forces affecting the cervical spine, even from walking. These may cause premature degeneration, because the dampening effect of the spinal discs is removed with insertion of rods and concentrated in the neck.

Karen Ocker
02-01-2009, 02:24 PM
Hopefully the newer pedicle screw surgeries can avoid the rapid degeneration seen with harrington rods.
Fix Scoliosis

Harrington rods haven't been used for a very long time and are no longer the standard of care. A major problem with the Harrington Rods was the lack of proper lordosis in the sagittal plane and possibly the thoracic-depending on levels affected. This brought about abnormal forces on the unfused discs and joints causing flat back syndrome. Harrington Rods were first used in the ~1970. My original fusion in 1956 was uninstrumented and only a modest correction was obtained after gradual "stretching out" in a plaster cast with a turnbuckle. That correction was lost after my uninstrumented fusion weakened over my lifetime resulting in a revision 6 years ago at age 60. My new instrumentation included: pedicle screws, Isola rods, pelvic screw, laminar wires and a cage. I am still totally pain free, working and living a fully normal life. My fusion levels: T-4 to sacrum. Pre-op curves: C=30, T=80, L=40. Post op:50% reduction .

I went back to work, gradually, 6 months post-op.

Pooka1
02-01-2009, 02:49 PM
written in a paper I read recently.

"The degenerated
idiopathic scoliosis mostly in the lumbar and/or thoracolumbar
spine is quite frequently combined with
spinal stenosis at a relatively young age, specifically in
the adjacent lower segment after Harrington instrumentation.

Okay, what about thoracic curves with Harrington instrumentation (just for my own amazement because Harrington rod surgery isn't really relevant to folks with modern hardware)?

FixScoliosis
02-01-2009, 09:05 PM
Sharon, I don't recall reading any reviews purely for Harrington rods in thoracic curves. I do have a lot of research papers (about 1200 articles related to spine and scoliosis), but not everything. :(

Karen, I am happy that modern surgery could help you. Good surgeons today are very GOOD when using latest technology.

Despite my personal conviction that better treatments can be found for AIS than bracing followed, in many cases by surgery. There is a time and a place for surgeons. We need them in modern health care.

concerned dad
02-02-2009, 11:13 AM
The thread is taking a bit of a bend OT, that’s fine. Let’s see if I can follow and perhaps bring it back around.

That’s an interesting perspective Sharon. As I understand you, you’re basically saying that perhaps since:

1. recovery from surgery is easier on the young than the old
2. Large curves progress and some are likely to progress to require surgery
3. There have been significant advances in surgery such that, while recovery is not trivial, it is not as extreme as in years past.

Then one might as well get it over with at a young age. Sort of (not exactly, but loosely) like a Chicken Pox party where parents expose their kids to Chicken Pox at a young age (when it is easily tolerated) rather than have them get exposed as an adult (when it is often more severe). I guess the presumption is that future advances in surgery will not be as dramatic as the ones over the last 30 years. I may not be following you here but this makes sense I think. The curve progression thing is supported by a figure in the report I mentioned above (the one that ‘salvages’ some data from the 1995 SRS bracing study). That figure is attached.

And then Fixscoliosis argues that surgery is a last resort w/references to Harrington Rods and stuff (I’ve stayed away from the surgery part of this forum as that stuff is way over my head).

And Karen then comments that surgery has advanced significantly from the days of Harrington Rods and point 3 above is valid.

Wow, that is something to ponder. Of course, with the SpineCor, the 5 year data show the curve amplitude decreasing with time (yeah, I know we still need to iron out all the weaning and over compliance stuff, but still…..). Whereas the attached figure shows the curve amplitude increasing (with a TSLO Brace).

Pooka1
02-02-2009, 01:15 PM
The thread is taking a bit of a bend OT, that’s fine. Let’s see if I can follow and perhaps bring it back around.

That’s an interesting perspective Sharon. As I understand you, you’re basically saying that perhaps since:

1. recovery from surgery is easier on the young than the old
2. Large curves progress and some are likely to progress to require surgery
3. There have been significant advances in surgery such that, while recovery is not trivial, it is not as extreme as in years past.

Then one might as well get it over with at a young age. Sort of (not exactly, but loosely) like a Chicken Pox party where parents expose their kids to Chicken Pox at a young age (when it is easily tolerated) rather than have them get exposed as an adult (when it is often more severe).

Your points #1 and #3 are clearly true for most people, point #2 needs some unpacking.

I want to stress that my thoughts about my daughters are predicated on the assumption that they do NOT have AIS but rather scoliosis secondary to a connective tissue disorder. I am also mindful about the outcome in my one kid (fusion) because it necessarily is related to the outcome in my braced kid (her identical twin). My decisions might be different if I was dealing with AIS or only one kid. :)

Our surgeon insists that only about 5% of people who make it to Risser = 5 with a sub-surgical angle ever progress in adulthood. If that's true, this 5% appears to be overrepresented in this little sand box as far as I can tell.

For the same reason bracing is known not to work for certain connective tissue disorders including Marfans Syndrome, I think the people who progress in adulthood might also be from this group in addition to women who are pregnant... apparently it has been shown that progesterone is linked to curve progression in adult women per Pam.

Some of these points are made in this thread...thread (http://www.scoliosis.org/forum/showthread.php?t=7824)


I guess the presumption is that future advances in surgery will not be as dramatic as the ones over the last 30 years.

I agree that is a big wildcard. For all we know, this surgery might eventually be done as an outpatient. Or they will figure out how to stop progression very early. Who knows.

What I do know is that surgery cured my one kid (she is not predisposed to back issues over and above anyone else) and I hope for the same result for the other.


I may not be following you here but this makes sense I think. The curve progression thing is supported by a figure in the report I mentioned above (the one that ‘salvages’ some data from the 1995 SRS bracing study). That figure is attached.

That is a slower progression than the one degree a year thing but may be related. Of course at this point, I don't thing much of averaging these data.


Wow, that is something to ponder. Of course, with the SpineCor, the 5 year data show the curve amplitude decreasing with time (yeah, I know we still need to iron out all the weaning and over compliance stuff, but still…..). Whereas the attached figure shows the curve amplitude increasing (with a TSLO Brace).

That stuff raises more questions than it answers at this point IMO.

concerned dad
02-02-2009, 01:37 PM
That is a slower progression than the one degree a year thing but may be related. Of course at this point, I don't thing much of averaging these data.



"Sand Box", I like that

regarding curve progression, There was a link on Linda Racine's website to a discussion of this. The link is 'busted' now but worked a month ago.

I happened to have done a copy of the info and just found it, although I cant attribute the source. Not even positive this is from Linda's site but she does have a busted link to a curve progression reference that I am almost certain worked when I first looked.

In adults, progression depends on the degree of the curve. Minimal progression can be expected in an adult whose curve is less than 30 degrees.5,14 A 40- to 50-degree curve in a skeletally mature person will progress 10 to 15 degrees over a normal lifetime, and curves greater than 50 degrees progress 1 or 2 degrees every year.2,14

Of course, it would be nice to know what those reference numbers 2, 5 and 14 are from.

Pooka1
02-02-2009, 01:58 PM
Okay that's a start.

I don't know when surgeons pull the trigger on surgery. I don't think there is one number because it will depend on the rate of curvature, among a boatload of other things.

I think they generally will suggest surgery above 45* irrespective of anything else but I don't know that. But that is in the group that is only expected to increase 10-15 over a lifetime. So that's confusing. Maybe I'm wrong about when they generally suggest surgery.

For my one daughter, he said she needed surgery soon when she was 48* with a known high rate of curvature. Two months later on the table, she was 58*.

concerned dad
02-02-2009, 05:05 PM
not sure if anyone is interested, but I've been trying to find available SpineCor data/papers.
Here is one that is posted on a UK website. Looks very old and does not appear to have been actually published anywhere.
Curve Reducability (http://www.healthcare.uk.net/SpineCor/ScientificInformation/The%20Reducibility%20of%20Idiopathic%20Scoliosis.p df)

It looks at the predictive value of the initial inbrace correction. Not sure if it is indeed the initial correction they are looking at or the one 1 month in. In any event it is an interesting discussion. A bit hard to follow along with the language.
They do make the statement to the effect that they have some patients who do not get a good initial inbrace correction. And these are the most likely to fail (go on to surgery). At least, I think that's what is said.

Maybe it was published....
How about this?
Coillard C, Leroux MA, Zabjek KF, Rivard CH. La réductibilité des scolioses idiopathiques dans le traitement orthopédique. Annales de Chirurgie 1999 53 (8) 781-791.

Pooka1
02-10-2009, 07:04 AM
If the Clear Institute is doing science, why do they make so many quacky claims? Why don't they publish their results in the refereed literature? Why do they appear to be a shoo-in for quack of the month over at Quackwatch?

Were your daughter's radiographs read by an orthopedic surgeon or a lay fitness coach?

concerned dad
02-11-2009, 06:11 AM
OK, that was, as my daughter would say, "random".

My daughters xrays were read by a surgeon.
However, I received a copy of the xrays on disk. It came with some fancy software. There was a digital tool for drawing lines and measuring angles.

I googled some stuff to see what angles to measure. Drew 2 lines, and BINGO, I got exactly 38 degrees. The same number the surgeon measured.
Dumb luck, maybe, but it didnt seem like rocket science. At least the measuring of the COBB angle stuff.

I should note that I did this for fun and to satisify my curiosity. I am leaving it to the experts to read the xrays.

I should also note that the software only read to the nearest degree. Hence 38, not 38.6. This is what turned me off to the NYC Chiropractors. On some youtube videos I saw references to them discussing COBB to the nearest 10th of a degree. My undergraduate degree is in engineering and I have some appreciation for significant digits - when they are valid and when they are not. Sometimes attempts are made to substantiate weak claims by implying exactness in a measurement. I didnt buy it.

Regarding CLEAR, I havent looked into it. Nor have a really looked into Schroth. I would need to see some technical literature and I guess that is the problem. I dont think the SRS folks think highly of it but I do think SOSORT may have a different view.

Pooka1
02-11-2009, 07:05 AM
That was NOT addressed to you, Concerned Dad!

I meant to post that on the thread with the Clear Institute (shill?) posting to it.

You are about the last person to trust your daughter to anything less than top shelf, science-based, non-woo-woo care.

Pooka1
02-11-2009, 07:13 AM
That post was in response to a rant posted by hope404 which I see s/he deleted. Good thing.

I pop open several widows to respond to threads and I put that post in the wrong thread.

Let's see if hope404 can respond to any of the questions posed. Anyone want to bet?

concerned dad
02-11-2009, 02:29 PM
Ahhhh, multiple windows, that makes sense.

I thought perhaps you might have been opening the door to discuss CLEAR.

I'm not ready for that yet.... still trying to rationalize/understand the whole bracing thing. That Danielson paper I commented about on Feb 1st still has me scratching my head. That last sentence still troubles me:

Our present results do not change the principal conclusion of the original SRS study: that well-performed brace treatment prevents curve progression during adolescence in patients with moderate AIS, while observation as the intended treatment allowed 70% of patients to escape any treatment at all and left 10% with surgical treatment and 20% with brace treatment.

On one hand you can then say that it showed brace treatment had a positive effect.

On the other hand the data suggests that bracing unnecessarily treats 90% of the kids to save the 10% from surgery.

Maybe I'm not thinking about this right. But, what are the limits we would accept. Would we unnecessarily treat 99% to save 1% from surgery? obviously, we would want to unnecessarily treat as few as possible.

I guess it comes down to the 'hardship' or burden of the treatment.

Pooka1
02-11-2009, 04:34 PM
Actually, I think I was wrong about that. I think hope404 DID post in this thread and then deleted all the posts later. I should have quoted him/her in my post. Next time we get a drive-by woo-woo, I will be sure and quote them in my response.

In re bracing, I think the surgical techniques, fusion and non-fusion, will improve at a rate that will not allow time to sort out the bracing business. Some fusion surgery is curative right now.

RugbyLaura
02-11-2009, 05:17 PM
Yes Sharon, there definately was a drive-by woo woo here, and in several other threads. Pam was onto her too.

Seems that all of her posts have been deleted - I didn't know this was possible. Am going to try it out now just for fun. Yeah, it worked, it's easy.

Hmmm, not sure where I stand on your point above...

Is spinal surgery ever likely to be preferable to a few years in a relatively easy to wear brace such as Spinecor? Speaking as a mum who has not come 'out of the other side', I'd say not. My daughter, however, would probably go for the instant fix & pretty clothes.

Friends whose children have had their surgeries are a lot more comfortable about their subsequent children so I guess maybe surgery could be better than years of bracing?? You've confused me now! Should I let Immi grow to a reasonable height then take the brace off & let her enjoy a brace free life until (probable) surgery? Get the surgery over with & forget about blasted scoliosis (at least for a while)?

Hmmm. Probably had a glass of wine too many, will have another think tomorrow.:confused:

Pooka1
02-11-2009, 05:36 PM
Laura, those are all well taken points.

I sense your concern about "spinal" surgery. It certainly sounds scary. But so does emergency surgery to repair a ruptured ectopic pregnancy (saved my life!), open heart surgery and liver transplantation. Either the technology is adequate or it isn't. Apparently, it is in all these cases and more, "ick" factor aside.

I think the situation with AIS or some other type scoliosis in an older child can be (not always) a more straight-forward situation.

In re JIS, everything is dicier. If wearing an easy to wear brace is curative then that is definitely better than surgery, almost irrespective of the number of years and even if the surgery is curative. I think only Spinecor is making any noises about a brace being curative (reducing a larger curve permanently below some low threshold that is known not to worsen over time).

To date, though, I think the Ti ribs, growth rods, and VBS, though all experimental, have more data on benefits than any brace.

I don't think a hard brace can be said to be superior to even non-curative but vastly beneficial surgery. The night-time braces seem innocuous enough but have not been shown to be curative.

Just my opinion.

RugbyLaura
02-11-2009, 05:49 PM
...emergency surgery to repair a ruptured ectopic pregnancy (saved my life!)

Mine too.

btw, you might be interested in the conversation re BrAIST here: http://www.scoliosis-support.org/ You might even recognise some of the participants...

Pooka1
02-11-2009, 07:34 PM
Mine too.

btw, you might be interested in the conversation re BrAIST here: http://www.scoliosis-support.org/ You might even recognise some of the participants...

Wow. Great thread.

But we now have to wonder which is Concerned Dad's favorite forum, this or that? :eek::D

That forum has a researcher posting which is a big draw. I fear we can't compete. :(:(:(:(:(:( (:))

emarismom
02-11-2009, 07:45 PM
"But so does emergency surgery to repair a ruptured ectopic pregnancy (saved my life!)"


Me three! Is there some type of connection here between ruptured ectopic pregnancies and children with scoli.

christine2
02-11-2009, 07:53 PM
We will always be concerned dads favorite, I am sure!! ;)

Pooka1
02-11-2009, 08:00 PM
We will always be concerned dads favorite, I am sure!! ;)

Speaking of which...

I note you posted "there" also.

I guess we have to sit here and silently wonder about your allegiances, also. :D

What next... Ti Ed secretly posting on some other group?? :eek:

christine2
02-11-2009, 09:23 PM
I do like the dialogue on the Braist study. I am having an awful time registering though, so need to go on unregistered. That is fine for now. I can stay incognito like Concerned Dad. Opps that back fired on him.

Concerned Dad How did you get registered so fast. I have been trying since Monday.

RugbyLaura
02-12-2009, 02:56 AM
Christine... Incognito?? I think I may have spotted you!


Hi Sealy,
This is Christine from NSF.
:D

pm me your email and I will try to get someone to sort you out.

Laura

concerned dad
02-12-2009, 10:11 AM
Other Forum? I dont know what you guys are talking about.

:D

Come on, I was just kidding. I was going to point everyone over there this morning. I've been out of town. Pretty neat that she is posting and addressing all the questions. Except perhaps the one Sealy asked. I had a hard time reading between the lines. Sealy made a comment about understanding that she cant address everything on a public forum. Is her point regarding the 30 degree thing? I mean, is Sealy basically saying

"your study is flawed because we know that most curves over 30 degrees entering adolescence will progress to surgery regardless of bracing" and "by including curves between 25 and 40 you're loading the bases" (these arent direct quotes, just paraphrasing from my faulty memory). And then she (Sealy) cites some papers about the 30 degree thing.

Did I read between the lines correctly? I'm not sure about the authority of that 30 degree asertion but it seems to be the table from the SRS site.

Now, it may be interesting to consider some other things she said.

1. The Danielson paper came out after her metaanalysis paper so it wasnt included. I wonder how the results would change if it was indeed included.

2. She reports anecdotally about physicians reporting patient uncomfort while wearing the SpineCor. This is contrary to our experiences here.

Pooka1
02-12-2009, 11:19 AM
Well, I have to admit when I saw some posters from here posting over there, my lower lip involuntarily stuck out and started to quiver. I'm over it now (for the most part). :)

I have looked at that forum; my impression is if this one is slow, that one is glacial.

I'll have to re-read Sealy's comments but is she saying that bracing of > 30* curves should not be done because it is known to fail? Is that equally true for T and L curves? Also, depending on number of patients, they might be able to demonstrate that bracing can delay progression enough until a higher bone age is reached. This is something that is often claimed but has never been shown to my knowledge.

RugbyLaura
02-12-2009, 11:33 AM
2. She reports anecdotally about physicians reporting patient uncomfort while wearing the SpineCor. This is contrary to our experiences here.

I read her meaning to be uncomfortable intellectually rather than physically - ????

concerned dad
02-12-2009, 01:00 PM
I read her meaning to be uncomfortable intellectually rather than physically - ????

Well, I spoke with a physician in the BRAIST study (our 'local' ortho) and he said his patients were physically uncomfortable in the SpineCor. He said their main complaint was the piece of plastic in front. He specifically outlined three options for us:
1. Stay with the SpineCor
2. If the SpineCor was too uncomfortable and we still wanted to feel proactive, switch to a nightime Providence
3. Unbrace (based on her skeletal age and the fact he doesnt KNOW if bracing is beneficial)

I mentioned before that I really like this doctor. But I am still confused by the comfort issue with the SpineCor. Makes me wonder if they didnt have it fitted right or applied correctly. Heck, Wong made the same point in his Hong Kong paper where he also looked into acceptance. See the table from his paper attached.

It would be very interesting to hear the perspective of someone who has worn both a Rigid brace and a SpineCor.

Oh, and in the table, S is SpineCor and R is Rigid Brace

concerned dad
02-12-2009, 01:10 PM
I'll have to re-read Sealy's comments but is she saying that bracing of > 30* curves should not be done because it is known to fail?

No, I think Sealy is saying that by not including smaller curves the BRAIST study is loading the dice. The data she cites suggests that curves greater than 30* (entering PHV) have a high likelihood of progressing to surgery. Dr Dolan said they recently lowered the inclusion criteria to 20 degrees.

tonibunny
02-12-2009, 02:30 PM
Well, I have to admit when I saw some posters from here posting over there, my lower lip involuntarily stuck out and started to quiver. I'm over it now (for the most part). :)

I have looked at that forum; my impression is if this one is slow, that one is glacial.



Awww be nice to us Sharon, we're only a little forum and we're based in the UK so we're probably very quiet when US peeps visit :o Lots of us are members here too and we regularly send people over here and to Spinekids, so there's no need to be worried that people will pick one forum over the other, there's room for us all :D

Toni (mod at SSO) xx

RugbyLaura
02-12-2009, 04:23 PM
Well, I spoke with a physician in the BRAIST study (our 'local' ortho) and he said his patients were physically uncomfortable in the SpineCor.Concerned Dad, I obviously got that completely wrong! I honestly thought they were 'uncomfortable' with Spinecor from a medical point of view :o

Heck, Wong made the same point in his Hong Kong paper where he also looked into acceptance. See the table from his paper attached.That table is awful! I assume you have read Spinecor's rebuttal (http://www.spinecorporation.com/English/News/Rebuttal%20to%20Dr%20Wong%20SpineCor%20Study.pdf)? When I first saw the results of the Wong study I had a major wobble & was very distressed. Having looked further into it & spoken to Mr Mills I can now see its huge flaws.


It would be very interesting to hear the perspective of someone who has worn both a Rigid brace and a SpineCor.Immi has worn both - although she only wore the TLSO for about half an hour! I assume they get easier with time but for her there is no comparison. A friend's daughter also wore a TLSO, for about a year (I think??), before swapping to Spinecor - for her, too, the Spinecor won hands down in terms of comfort. Unfortunatley he no longer visits the forums so I can't put you on to him. You'd have liked him.

I really don't know where they're coming from... Maybe people who seek an easier wearing brace are less stoic that those who accept the TLSO without seeking an alternative? Immi really has very little issue with wearing it (Spinecor) - in fact the worst thing for her is the 'faff' of putting it on & taking it of which, I note in the Wong study, is one of the least complained of aspects. My biggest problem with it is that capital C in the middle. It's just too gimicky. But maybe that's just me, being British.

I get really frustrated that Spinecor is dismissed so easily - hopefully that will change. We now have 5 surgeons in the UK prescribing Spinecor; they are considered 'mavericks' by the rest of the surgeons. However, they (the rest) are all watching with interest and looking forward seeing the results of the collected data (which should be out in about 2011). At least then we should know one way or another...

Hi Toni, I sent Mark an email about Christine's inability to register (he was the only mod around at the time) - could you have a look too? Thanks!

concerned dad
02-12-2009, 04:32 PM
I honestly thought they were 'uncomfortable' with Spinecor from a medical point of view :o



Well, perhaps it is both. Dr Dolan said that both the doctors and patients were uncomfortable. I dont see how a doctor could be physically uncomfortable with someone else wearing a brace.

tonibunny
02-12-2009, 04:34 PM
Hi Toni, I sent Mark an email about Christine's inability to register (he was the only mod around at the time) - could you have a look too? Thanks!

Just taking a look now :) Sorry to butt into your thread chaps!

Pooka1
02-12-2009, 04:58 PM
Awww be nice to us Sharon, we're only a little forum and we're based in the UK so we're probably very quiet when US peeps visit :o Lots of us are members here too and we regularly send people over here and to Spinekids, so there's no need to be worried that people will pick one forum over the other, there's room for us all :D

Toni (mod at SSO) xx

Well, you have the large advantage of having a researcher posting over here. So naturally I would be jealous. :)

Do you find you need to do much moderating? Would you say it is ever a runaway train? :eek:

sharon

concerned dad
02-12-2009, 04:59 PM
When I first saw the results of the Wong study I had a major wobble & was very distressed. Having looked further into it & spoken to Mr Mills I can now see its huge flaws.


Yes, but I wonder why there was never a rebuttal to the 2005 Weiss paper. Maybe there is and I just havent seen it. But it deals exclusively with girls in the growth spurt and Weiss says 11 out of 12 of them failed (curve increased 5 degrees) with the SpineCor.

Did you ever ask Mr Mills his opinion about that? I didnt bring it up with Dr Rivard or Colliard. But, it sure would be interesting to hear what a medical professional thinks about that paper.

I mean, is it possible that the SpineCor is a good brace and can even gradually reduce a scoliotic curve in girls who are growing slowly. But might it fall short when aggressive growth occurs? I'm not saying it does, just asking. That's why I asked on the SpineCor thread if we have anyone here who has a child braced with the SpineCor through her adolescent growth spurt. It MAY be one thing to brace with SPineCor after the growth spurt (like my daughter) or before the growth spurt, Like your daughter. But what happens during that growth spurt. If I hadnt seen the Weiss paper I wouldnt even be asking. But it is a troubling loose end.

tonibunny
02-12-2009, 05:10 PM
We have a team of moderators and there's usually at least one mod online during the day as some of us work with computers anyway and can keep a window open on the website :) Most of the moderating is to keep posts in the correct forum, remove swear words, and help with registration problems but very occasionally (as with here) we'll get someone posting about emotive subjects such as "miracle" alternative treatments and have to be careful to keep the ensuring discussions calm.

concerned dad
02-12-2009, 05:15 PM
Well, you have the large advantage of having a researcher posting over there.

Yes, but we have you here Sharon. And I swear, I was rereading Dr Dolans posts and thought it could have been you writing in defense of sound scientific practice. If she had thrown in a horse comment or two I would have found you out. When she said (regarding PT) "I commend the dedication of these clinicians to conservative treatment and I look forward to reading results of large-scale controlled trials from their institutions." I had to laugh out loud because of the whole "controlled study" thing we had going on in December.

And I just want to say Happy B'day CD. And CD isnt Concerned Dad.

RugbyLaura
02-12-2009, 05:24 PM
That's why I asked on the SpineCor thread if we have anyone here who has a child braced with the SpineCor through her adolescent growth spurt. It MAY be one thing to brace with SPineCor after the growth spurt (like my daughter) or before the growth spurt, Like your daughter. But what happens during that growth spurt. If I hadnt seen the Weiss paper I wouldnt even be asking. But it is a troubling loose end.

Here's my problem. I don't know of anyone who has made it through...

But then I only 'know' half a dozen girls. I fully expect Immi's curve to go crazy at about 12/13, like the others.

However, our 'sceptical' surgeon says that he sees a girl who presented with Immi's size curve at similar age who is now going through weaning and maintaining a mid 20s curve.

And to put it into perspective; I have known far more kids in TLSOs and none of them has made it through either.

I will certainly ask Mr Mills about the Weiss study - I have a feeling that I already have but everything gets a bit jumbled. He won't mind me asking again! The problem is that it's hard to find any kind of impartial study.

(Ahh, got the CD reference :cool:)

jillw
02-12-2009, 06:43 PM
...is it possible that the SpineCor is a good brace and can even gradually reduce a scoliotic curve in girls who are growing slowly. But might it fall short when aggressive growth occurs? ...... It MAY be one thing to brace with SPineCor after the growth spurt (like my daughter) or before the growth spurt, Like your daughter. But what happens during that growth spurt......

Concerned Dad, I have wondered the same thing about spinecor and assuming things remain fairly stable with my daughter's curve (and that's not something I'm taking for granted by any means, but just for the sake of argument) I'm not sure what we'll do when she approaches peak velocity growth. We still have a few years until that occurs so maybe future research will give me more guidance on that issue. However as things stand now, I'm inclined to think I wouldn't want to chance it with spinecor alone (unless her out of brace curves had been brought down to nearly nonexistant). I had been thinking maybe a hard brace during the night (when there isn't as much chance for muscle atrophy due to near inactivity anyway) and maybe spinecor by day? Of course that would require 2 different doctors to agree to work together and i'm not sure many are thinking outside the box on that yet. Dr. Rivard had said on a couple occasions that the challenge would be getting her through that future peak velocity growth spurt....

Pooka1
02-12-2009, 07:12 PM
Yes, but we have you here Sharon. And I swear, I was rereading Dr Dolans posts and thought it could have been you writing in defense of sound scientific practice. If she had thrown in a horse comment or two I would have found you out. When she said (regarding PT) "I commend the dedication of these clinicians to conservative treatment and I look forward to reading results of large-scale controlled trials from their institutions." I had to laugh out loud because of the whole "controlled study" thing we had going on in December.

Science is science. :)


And I just want to say Happy B'day CD. And CD isnt Concerned Dad.

Great thought!

With the possible exception of Sir IN, CD has contributed the most to science I think. It is hard to overstate the magnitude of the contribution CD made even before all the newer sciences were able to corroborate the idea. It is the quintessential paradigm shift. He changed everything by finding the real explanation after a few thousand years of honest but incorrect attempts.

It is arguably the single largest contribution to science and therefore to humanity to date.

Pooka1
02-12-2009, 07:17 PM
Most of the moderating is to [...] remove swear words, [...]

:eek:

How are people then able to react properly when someone posts a Cobb angle in tenths of a degree??? :confused:


(;))

tonibunny
02-13-2009, 07:29 AM
:eek:

How are people then able to react properly when someone posts a Cobb angle in tenths of a degree??? :confused:


(;))


:D :D :D

Sorry for taking this thread off topic, back to Spinecor! :p

Toni xx

RugbyLaura
02-13-2009, 08:33 AM
Yes, but I wonder why there was never a rebuttal to the 2005 Weiss paper. Maybe there is and I just havent seen it. But it deals exclusively with girls in the growth spurt and Weiss says 11 out of 12 of them failed (curve increased 5 degrees) with the SpineCor.


You've got me thinking... 'failure' is having increased by 5 degrees? But that is within the margin for measurement error. Seems rather daft to me. Given the rate at which these curves often (usually?) grow during PVG (is that the correct abbreviation?), +5 degrees looks more like success than failure?

I'd like to have another look at this study - could someone point me in the right direction, please? I will ask the question about a rebuttal once I've had a look.

And Toni, I'm sure they'll love the little light-hearted detour.

concerned dad
02-13-2009, 10:37 AM
the Weiss paper is

Brace treatment during pubertal growth spurt in girls with idiopathic scoliosis (IS): a prospective trial comparing two different concepts.Weiss HR, Weiss GM.

Pediatr Rehabil. 2005 Jul-Sep;8(3):199-206.

Yeah, 5 degrees. I'm not saying I endorse the paper. I'm just saying I would like to know more. It is troubling. While discussing Colliards paper he makes the case that:

In a recent publication, Coillard et al. [23] present the post-treatment results of the SpineCor. Inclusion criteria for that outcome study were the diagnosis of idiopathic scoliosis, an initial Cobb angle between 15-50° and a Risser sign of 0-3. Survival functions were presented leading to the conclusion that 'for patients followed up from the initiation of treatment to 2 years follow-up, there was an overall correction/stabilization for 93% of the patients'.

One important problem of this study, however, has to be discussed: Scoliotic curves progress mainly during pubertal growth spurt [24]. As can be seen in Figure 3 [25], growth spurts in girls comprises only a short period of time while the age of 6-10 years, usually there is no change of curvature even in an untreated patient with a curvature of >20°. On the other hand in post-menarchial girls with Risser stages 2 or 3 in minor curvatures, no change of Cobb angle has to be expected [26, 27]. So, the inhomogenous age group (6-14-years-old patients) offers no chance to distinguish between patients at immediate risk or at no risk for further progression of the curvature. A study of patients treated with the SpineCor brace during pubertal growth spurt seems desireable.

The paper Weiss is discussing refers to Coillards 2003 paper . In her more recent paper she reported the results consistent with the SRS bracing study criteria (ie age >10 and premenarchal, Riser 0,1 or 2....) so perhaps her recent paper addresses (indirectly) Weiss's critique. In fact, looking at it now, that seems to be the case.

Pooka1
02-13-2009, 01:02 PM
If the measurement precision is +/- 5*, the failure point has to be set at some point higher than that.

Setting it at >5* is actually the MOST conservative approach. He would have been blasted had he chosen a number far above the precision of the measurement. That is, this will identify the MOST number of "failures."

Now he can go on and table the extent of failure (how far above 5) and possibly asked why he didn't do it if he doesn't. But he should not be understood to be claiming "6* is a failure" per se. I believe that is an incorrect interpretation of the approach.

Love,
a random yahoo

RugbyLaura
02-13-2009, 05:21 PM
Dear Random Yahoo,

Crikey, that's all Greek to me! I'll have another look at it in the morning & hope that it makes sense then. I think my brain is degenerating through all this worry.

CD,

growth spurts in girls comprises only a short period of time while the age of 6-10 years, usually there is no change of curvature even in an untreated patient with a curvature of >20°. Again, I'm struggling with the language but would like to point out that my daughter's curve progressed from 28 to 38 degrees in 7 months while she was 9. Have I got the point wrong?

Pooka1
02-13-2009, 06:38 PM
My point is that he must pick a Cobb angle increase that is not in the noise. Anything less than 5* is in the noise of the measurement error.

That is the reason he uses >5* as an indicator of a "failure." A better, less confusing term instead of "failure" would be using >5* as an indicator of an "increase." He is simply using the term "failure" as the smallest increase he can confidently measure. It's obviously not a failure if you start at 20* and end at 26* so he doesn't mean that.

He can't say a +3* change is a "failure" or even an "increase" because he can't be confident that it is a real increase because it is smaller than 5* and therefore within the measurement error (precision).

So whatever number he picks, we know it must be >5*

Now if he picks a 10* increase then he is not counting the curves that we know definitely increased (between 6* and 9*). So rather than miss any observable increases, he sets it at the top of the error bars, 5*. This will catch all measurable increases in curves.

Is that clearer?

RugbyLaura
02-13-2009, 06:50 PM
Yep

(thanks)

concerned dad
02-14-2009, 10:30 AM
A better, less confusing term instead of "failure" would be using >5* as an indicator of an "increase."

snip

Is that clearer?

Yes, good explanation. Isnt there a similar thing going on with "false" and "wrong"?
Is there a reason that greek statistics fellow we were discussing earlier didnt title his paper ".... most published research findings are wrong" instead of the term he used ".... most published research findings are false".

Pooka1
02-14-2009, 11:03 AM
"False" and "wrong" can both mean erroneous.

Maybe "false" is more commonly used for fact cases whereas "wrong" is more commonly used for moral or ethical situations?

michele27
02-14-2009, 01:48 PM
Hi,

This does not directly address the issue of the age and development of a patient treated with Spinecor vs. curve progression, but may give a little more insight to the overall results of Dr. Weiss' study. That is assuming there was only one 2005 Weiss study concerning Spinecor(otherwise this may be irrelvant). I found this in the forum archives, but I couldn't find an "official" published rebuttal like the one published in response to the Wong study. Sorry, it's a little long!

Michele


Dear Dr Rivard

I hope you do not mind that I write directly to you.

I live in the UK and unfortunately my
daughter (now 11 years 10 months, no Menarche yet) was
earlier last year diagnosed with a T12 25 degree scoliosis,
progressing in some months to 29 degree. With a hard brace
(febr 2005) we achieved a 25 % correction, (down to 21 degree
in brace) and on review this month we seem to be stable, in
that the curve is still 29 degree.

I am concerned that with the current brace we are not
achieving as much correction as we should/ could be getting,
and as we are due a new brace anyway, I am reconsidering my
options.

I think that at least I need to "press" for better correction
from our next hard brace, but having "looked" at the
Spinecor, and reading the studies published on the
Spinecorporation website I do wonder whether this is an
option for us.

Although the results as published seem impressive, i am
worried that the concept doesn't appear to be having the
wholehearted backing of the orthopaedic community and
specifically that, as i understand it, The Nuffield Hospital
Oxford pulled out of the joint study (with your own
hospital), because they were not happy with the results. The
other worry is the study which i saw, by dr Weiss, who
questioned to effectiveness of the brace as well.

Have you got any insight as to why use in Oxford and through
Dr Weiss were not succesful, and are you able to reassure me?

I understand that a further study by yourself will be
published soon. Are you able to advice me when and where they
will be published, and are you already able to give any
outline of the results?

I would be grateful for any advice you might be able to give
to help to settle my anxieties. I am well aware that I cannot
afford at this stage to make a wrong choice with regards to
my daughter's treatment, as she will have to live with the
consequences forever

With regards

Gerbo Huisman
Lichfield, UK


and the reply from Andrew mills of the Spinecorporation



Dear Mr Huisman

Your email has been forwarded on to Dr Rivard however; I can easily answer your questions. More reduction in a rigid brace will not necessarily make any significant difference to the outcome.
Rigid bracing at best will prevent progression from the initial pre-treatment cobb angle, applying more force to give the illusion of more correction on an in brace x-ray may make you feel the treatment is better but that is not necessarily the case at all. There is some debate amongst practioners about the compromise between reduction of major curves, compensatory curves and balance, from my point of view all three should be considered and one not optimumized at the expense of the others.
For 12 - 24 months post rigid brace treatment curves will tend increase until they stabilize out, generally close to where treatment started.

At your daughter’s age the risk of progression is, as you know very high and it is possible you may yet see more progression despite bracing.
SpineCor treatment will not perform miracles but offers the best possibly of achieving a final stable result post treatment with the lowest Cobb angle achievable in any particular case.
In Montreal we now have long-term follow-up, 5 years, post bracing in a large proportion of the original 400 patient study group.
Results of the latest follow-up, not yet, published show exceptional stability post treatment with overall better results than any conventional rigid brace treatment.
With more than 5,000 patients treated worldwide now there is no question in our mind concerning the efficacy of SpineCor Treatment. There have of course been some failures, which basically stem from failures in training. Our training program has changed significantly in recent years to prevent future treatment centre failures.

Dr Weiss, incidentally, treated a group of 20 patients with SpineCor braces on which he based his opinions. These treatments were carried without any training or following the SpineCor treatment protocols, not surprisingly the treatments failed.

Nuffield had issues with funding the SpineCor trial as well as great difficulty in recruiting patients with a randomised protocol for treatment vs. non-treatment. Only 5 patients were treated in 18 months against a recruitment protocol of 20 patients in 12 months. The lack of funding, some training issues and any enthusiasm from the team involved resulted in them just giving up.

In general there are huge problems to introduce SpineCor into the UK since orthotists who traditionally provide bracing treatments find SpineCor very challenging, added to this they are often under great pressure to see patients very quickly and simply do not have the time for SpineCor. Furthermore it needs to be understood that is a big learning curve with SpineCor and the skills required are very different to those for rigid bracing. For these reasons it is essential that trainees treat significant numbers of patients to develop their skills. The current SpineCor accreditation program demands a minimum of twenty patient treatments and 6 months experience before individuals are eligible for accreditation. In the UK there are few treatment centres that offer the opportunity to meet the training criteria in a reasonable period of time. A change in the method of treatment delivery is required for SpineCor to ever become mainstream in the UK.
Personally I am working on ways of changing the way SpineCor is made available to the NHS but this is likely to be slow.
The latest SpineCor treatment results have been submitted and accepted by the European Spine Journal but as yet we do not know when publication might be.

I hope this information is useful to you.

Kind regards

Andrew J Mills MBAPO
Managing Director/Orthotist

The SpineCorporation Limited



It is all a mrf10-26-2006, 10:01 AM
I actually asked Dr Rivard about the Weiss study and he told me several things:

1 - the study was only with 12 patients
2 - When he and Dr Coillard went to Germany to meet with Drs Weiss and instruct them on the proper fiting of the SPinecor they did not agree with Dr Rivard's directions as to how to fit the brace. He said that they insisted on fitting the brace as a three point brace which, according to Dr Rivard, is not the correct way to do it. Dr Rivard said that he trained their orthotists to do it the correct way but that when they went back to Germany, they were not fitting the Spinecor correctly.
3 - He did have follow-up consultations with Drs Weiss and that when he (Dr Rivard) showed his additional study results, Drs Weiss agreed with Dr Rivard but that was after their study was already out there.

It seems if #3 is true, then a rebuttal would have been published. Of course, there may be one and I just haven't been able to find it.
--------------------------------------------------------------------------------

Pooka1
02-14-2009, 03:33 PM
I would just like to say that a study on AIS (or any highly variable condition) with 12 patients is inherently not credible.

Just my opinion.

RugbyLaura
02-14-2009, 04:08 PM
Thank you, Michele, for hunting that down. That post was the catalyst for us (me) hunting down the Spinecor brace - via Gerbo.

Seeing it again takes me back...

concerned dad
02-17-2009, 09:42 AM
Yes, Thank you Michele for hunting that down and posting it.
Very interesting. And somewhat troubling. I recognized the name Gerbo as the person who started the Spinecor thread. Looking through his posts I saw one of the more recent ones say (from the Spinecor thread)

"Considering I started this thread, I might as well put you in the picture about our current situation. In line with what happened with melisaa's and cheryyl's daughter, we haven't been doing well at all recently, we had our latest check last wednesday and as feared; not good at all, primary curve; about 31, sec curve at T4 39 degrees, no difference in or out of brace, so she has been taken out of it"

So, apparently his daughter started with Spinecor after the email exchange above and before menarche. Things went well until she went through her growth spurt. Gerbo mentions 2 other names/forum participants. Melissa and Cheryl who appear to have had similar results to what Weiss predicted.

Dont get me wrong, we are staying with the Spinecor. I just want to understand as much as possible. This is a small sampling of 3 folks who had poor success. Anyone familiar enough with this forum to know if we (forum participants) have had success through peak height growth with the SPinecor?

Pooka1
02-17-2009, 12:29 PM
CD, it's a good thought but I suggest there are not enough testimonials on that to decide the matter AT ALL.

It's anecdotal, stem to stern.

concerned dad
02-17-2009, 02:03 PM
Yeah, but it would be reassuring to hear one testamonial. You know, something like .......
"my daughter had a 30 degree progressing curve, we put her in Spinecor at age 11 and now she is age 16 with a 25 degree stable curve".

Not scientific, just reassuring.

Pooka1
02-17-2009, 02:12 PM
I would wager it is almost certain, if you polled enough people, you would find folks with that exact testimonial, if only because not all curves will progress even if you do nothing and some may even improve if you do nothing.

Just because your daughter is wearing a Spinecor brace and even if it is known it usually doesn't holds curves like that, it may still be the case that her curve will stop/improve either with or without the help of Spinecor.

It is impossible to overestimate how little is known about Spinecor at this point. There certainly might be a group of patients for which is does usually work. Who knows. Nobody proved it can't work.

(ps. It is my secret goal to make this thread longer than the Spinecor thread. So I hope folks pitch in. Oh and don't tell anyone! :))

RugbyLaura
02-17-2009, 04:37 PM
(ps. It is my secret goal to make this thread longer than the Spinecor thread. So I hope folks pitch in. Oh and don't tell anyone!) Perhaps I should have posted Immi's xrays here and you might have commented on them :( Did I commit a forum faux pas?

emarismom
02-17-2009, 04:50 PM
Concerned Dad,

I have not seen the type of testimonial that you are looking for. I agree, it would be "reassuring" to have that type of testimonial!

Laura,

I did see Immi's xrays, they are quite impressive!! Congratulations.

Pooka1
02-17-2009, 04:52 PM
Perhaps I should have posted Immi's xrays here and you might have commented on them :( Did I commit a forum faux pas?

Nah that's okay.

I know it's going to be an uphill battle trying to make this little thread longer than the Spinecor thread. Hearts and minds will have to change. It's going to take time, probably years. :)

Pooka1
02-17-2009, 04:58 PM
Laura,

I did see Immi's xrays, they are quite impressive!! Congratulations.

They are impressive.

My vague impression from the anecdotal testimonials flying around is that Spinecor seems to have more apparent success with the JIS crowd than the AIS crowd. It's so new that there are likely few, if any, patients who started with Spinecor so young. That may be the crowd that benefits from Spinecor. Maybe wearing it starting at a younger age does increase its success of holding the curve through the growth spurt. We just have to wait for the data.

emarismom
02-17-2009, 06:36 PM
Sharon,

I wish I could say that I honestly believe that the Spinecor will prove to be at least "more effective" on the JIS group, than it appears to be on the AIS group. Especially given the fact that my daughter is in that group. However, it may just be that in the JIS group there is a long stretch from 6-10 where growth is slower and steadier. That was actually a huge factor in me bracing my daughter at age 8- to hopefully reduce the curve BEFORE she went through puberty.

It appears that use of the Spinecor in younger children seems to "control" the curve, as most of the people who post here seem to have younger children who are having success. It could also be that these curves
a) would not have progressed at all or b) still will progress as these children reach adolecence.

There should have been, within the last several years, many children who have gone through puberty while wearing the brace. Unfortunately, we have seen more failures of the Spinecor to control the curves than we have seen successes.

There may be many reasons for this. Maybe the parents of children who are doing well no longer need support from the forum, thus are not posting their successes. Also, many of the "failures" have been in children who were braced with larger curves. Some could have even been due to lack of compliance. I can remember specific cases where the children weren't 100% compliant with the 20 hours per day.

As Concerned Dad pointed out, there truly is a lack of testimonials of children going through puberty with success. It will be a long while before the data is out. Until that time, testimonials from other parents is the only feedback we have. While it doesn't replace sound scientific evidence, it does help.

Even without the scientific data, at this point in time, it seems Spinecor is the best option for kids with JIS or AIS who are at high risk of progression.

leahdragonfly
02-17-2009, 09:10 PM
Has anyone whose child is wearing a Spinecor asked their orthotic practitioner and/or Dr Rivard for more information about SpineCor graduates? Someone out there knows more than we do on this forum about the kids who are done growing and done with SpineCor.

IMHO, I am guessing that if there was a large number of such kids that had successful, Dr Rivard and colleagues would be publicizing that info. I know there are many of us parents out there who are dying to know that info. I would certainly have entertained the idea of SpineCor for my daughter (at age 6 with 26 degrees) if there was better/more scientific evidence.

Pooka1
02-17-2009, 09:15 PM
How long has Spinecor been around?

Have they been bracing JIS kids that entire time or did they start with AIS kids?

If the latter and they haven't been around long enough, there may be so few cases that is really wouldn't matter what they were. I really wonder if there is more than a handful of data on Spinecor plus JIS at this point.

The data they have published so far is all AIS, no?

emarismom
02-17-2009, 10:23 PM
I have only seen data related to AIS. I do know that there are some JIS kids who have been braced for at least 3 years, as they were and some still do post on these and other forums.

It really is interesting that I never thought to ask about current statistics with Emily's orthotist. That will be my #1 question for him the next time I see him. Although, his answer will likely be based on his personal experiences, and not on measurable data.

Maybe it would be an option to send an email to Dr. Rivard regarding the current state of the research with JIS. In the past when I have emailed him he has been very quick to respond.

I do think that there is more than a handful of JIS patients wearing Spinecor. Just do a search on You Tube and you will see quite a few testimonials.

Pooka1
02-18-2009, 07:11 AM
I do think that there is more than a handful of JIS patients wearing Spinecor. Just do a search on You Tube and you will see quite a few testimonials.

I was unclear.

I realize they are bracing JIS kids left and right now.

I meant there is likely only a handful of JIS patients who wore it long enough into adolescence and through the growth spurt to be able to ask whether the outcome for them is different from the AIS patients who didn't wear the brace for that long. This is more likely if they only braced AIS kids for the first several years after the brace was invented. I have no idea what those guys did... we would have to ask them.

RugbyLaura
02-18-2009, 07:44 AM
As I'm sure we've discussed before, the distinction between AIS and JIS is sometimes a bit fuzzy. For the purposes of studies Immi is classes as AIS as she was braced a week before her tenth birthday.

However, we know that she is really a JIS case as her curve has been around (and apparently progressing) since she was 7/8...

BTW, what I particularly like about Immi's most recent xray is the apparent reduction in the length of the curve. At the original appointment to fit her rigid brace, the orthotist said that she had an unusually long curve which made it hard to brace.

concerned dad
02-18-2009, 09:19 AM
The Spinecor has been around a lot longer than I initially realized. At least 10 if not 15 years.
There have been many kids who have gone through adolescents wearing it. I was just wondering if ANY of them (or their parents) were on this forum.

The following is from Dr Coillards most recent paper. Emphasis is mine.

Published in: Disability and Rehabilitation: Assistive
Technology, Volume 3, Issue 3 May 2008 , pages 112 - 119

Abstract

Purpose. To evaluate the change in spinal curvature and posture of Idiopathic Scoliosis patients when a curve specific 'Corrective Movement© Principle' (CMP) is applied.

Methods. This prospective interventional study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness followed the SRS outcome criteria for bracing. The clinical, radiological and postural evaluations assisted to define the patient classification, which guided the unique application of the CMP to each type of curvature.

Results. A total of 583 patients met the outcome criteria. Overall, 349 patients have a definitive outcome. Successful treatment was achieved in 259 (74.2%) of the 349 patients from the fitting to the weaning of the brace. Some 51 immature patients (14.6%) required surgical fusion while receiving treatment. Eight mature patients out of 298 (2.7%) required surgery within 2 years of follow-up beyond skeletal maturity.

Conclusion. The SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 151 (93.2%) of 162 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing.

Now lets consider the "51 immature patients." Dr Coillard says further on in the paper:

Percentage of patient who have had surgery recommendation/undergone before skeletal maturity. A total of 51 immature patients (14.6%) out of 349 who respected the inclusion criteria and who had a definite outcome (298 + 51), required surgical fusion while receiving treatment. The average curve magnitude at bracing in this particular group was 32.7° ± 6.1° (range: 17 - 41°). General indication for fusion in all patients was progression of primary curve of more than 60° in thoracic region and 45° in thoracolumbar and lumbar region.

She goes on to say that the average curve of the 298 successfully treated patients (at the start) was 26.3 degrees. I would be curious to know of any other difference (beside curve amplitude) between the two groups.

michele27
02-18-2009, 11:30 AM
Since my daughter is likely to begin her main growth spurt and menarche in the near future, the issue of Spinecor's effectiveness during adolescent growth is a major concern. I would love to hear from someone whose child was successfully treated with Spinecor through adolescence. One reason I think we hear of unsucessful treatment is because of the wait and watch protocol. Six months could be the difference between starting treatment under 30 degrees or not starting until 35+ degrees, making all the difference in the world when trying to hold or correct a curve. Of course, there is so much inconsistency with how to treat, when to treat, or even if to treat it's hard to say whether any brace helps or not. You just can't know if your child's curve would progress or stabilize on its own unless you choose not to brace at all. The main reason I have for wanting to try Spinecor is for the increase in mobility and comfort. If it doesn't work, we'll try hard bracing, all the while wondering if any of it makes a difference and I suppose we'll find out in the next few years.:) Thanks, CD, for finding the latest findings from Rivard/Coillard. It would be great if we knew of any other commonalities between the subjects that eventually required surgery.

Pooka1
02-18-2009, 12:40 PM
I can't find the text on line.



Results. A total of 583 patients met the outcome criteria. Overall, 349 patients have a definitive outcome.

What's the difference between "met outcome criteria" and "definitive outcome?"


General indication for fusion in all patients was progression of primary curve of more than 60° in thoracic region

Why 60*? Why not 70*? Why not 170*?

concerned dad
02-18-2009, 01:50 PM
I think Michele27 summed it up pretty good. As was the case with us, I detect the same uncertainty, frustration and ultimate resignation to try what seems best right now based on the data we have. Unfortunately, Michele's child is on the rising end of the growth curve and my daughter is on the waning end. It would be interesting if I knew what my daughters curve was 1 or 2 years ago. In that regard for my daughters progression, her pediatrician had scoliosis as a child. She said she always checks carefully. She did not note anything last year (this year (Nov) it was 38 degrees and she was the one to notice it). My daughters school screening in September missed it. Did it progress rapidly over the last year? Was it there for several years and just missed? I wish I knew. I thought it intersting that in the two months we had to wait to see Drs Rivard and Coillard her curve did not seem to progress at all(although the margin of error thing is there). I was pretty stressed over those two months that we were letting time slip by. Now I wonder if we are bracing unnecessarily. I guess I am holding out some hope that, so long as her wearing the brace is not a hardship, perhaps she might obtain some correction from her original curve.




I can't find the test on line.

What's the difference between "met outcome criteria" and "definitive outcome?"

from the Coillard paper

Respecting the criteria mentioned above, we needed to exclude some patients from the actual study. This prospective interventional study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. Some 583 patients respected the inclusion criteria, 234 (40.1%) did not complete the treatment by brace at the time of the analysis and 51 immature patients required surgical fusion while receiving treatment, leading up to 298 patients who had reached skeletal maturity at the end of bracing. Out of this cohort of patients, 162 patients had 2 years and 69 patients had 5 years follow-up post-bracing.

The "criteria mentioned above" was the SRS criteria

Definitive outcome are the sum of the patients who are finished bracing PLUS the patients who had surgery (or surgery recommended)



Why 60*? Why not 70*? Why not 170*?

Groundhog day :D The SRS wants the researchers to report the number of patients who required surgery AND the indications for surgery.

concerned dad
02-18-2009, 01:56 PM
BTW, what I particularly like about Immi's most recent xray is the apparent reduction in the length of the curve. At the original appointment to fit her rigid brace, the orthotist said that she had an unusually long curve which made it hard to brace.

The xrays are impressive. To my untrained eye I was surprised to hear that it measures as high as it did. Perhaps that has to do with the length of the curve.

Pooka1
02-18-2009, 02:10 PM
Groundhog day :D The SRS wants the researchers to report the number of patients who required surgery AND the indications for surgery.

I wonder what the stats would be if they picked a real world surgery trigger angle.

concerned dad
02-18-2009, 02:11 PM
One more thing (no I am not trying to bump the post count to challenge the SPineCor thread - it would never happen anyway) I forgot to mention that Dr Dolan posted a response on the UK forum. www.scoliosis-support.org in the thread titled BrAIST

Pooka1
02-18-2009, 02:17 PM
Dr. Dolan's response was very similar to what I mentioned... do NOT expect to see anything from a PowerPoint conference talk in a published article. One is peer-reviewed and one is not.

Moreover, those are old data that are still not in print in that form. I think they are interim angles measured in brace which would explain why they haven't been published.

Pooka1
02-18-2009, 02:24 PM
If I was Coillard, I would pick a surgery indication angle of 5,690*. The brace would look pretty successful. :D

concerned dad
02-18-2009, 02:25 PM
I wonder what the stats would be if they picked a real world surgery trigger angle.


oh come on. I admit I dont know what is considered "real world" but isnt this close? in fact, i thought the 45 was low (not that I really know).

General indication for fusion in all patients was progression of primary curve of more than 60° in thoracic region and 45° in thoracolumbar and lumbar region.

And what would the stats be? In accordance with the SRS guidelines, they report what the number of patients who progressed to 45 degrees was as follows:

Percentage of patients who progressed beyond 45°at maturity. Seven patients out of the 298 patients who had a definite outcome (2.3%) had documented progression of curve beyond 45° at maturity. Surgery was required for 3 of these patients.

So, I dont think they are jigging the data with their indications for surgery. Maybe that is what the canadian health system dictates. Who knows.
But they are at least reporting the data as suggested (by the SRS).

Pooka1
02-18-2009, 05:26 PM
Is this paper online somewhere? I'd like to look at it.

concerned dad
02-18-2009, 06:42 PM
Is this paper online somewhere? I'd like to look at it.

Not yet, but it is virtually identical to the European Spine Journal paper, just more/updated results.

But guess what I found ...... the entire SRS Bracing Criteria paper
SRS paper on Bracing studies (http://www.spinecorporation.com/English/ScientificInformation/Richards%20et%20al%202005.pdf)

:cool:

Pooka1
02-18-2009, 09:25 PM
But guess what I found ...... the entire SRS Bracing Criteria paper
SRS paper on Bracing studies (http://www.spinecorporation.com/English/ScientificInformation/Richards%20et%20al%202005.pdf)

:cool:

Note they suggest >45* as a possible need for surgery.

Not 60*.

Not 5,690*. :D

concerned dad
02-19-2009, 11:06 AM
Note they suggest >45* as a possible need for surgery.

Not 60*.

Not 5,690*. :D

What the SRS want to see reported is:

b. The percentage of patients who have had surgery recommended/undergone before skeletal maturity (i.e., the time when the orthosis would normally have been discontinued). The surgical indications must be documented.

c. The percentage of patients who progress beyond 45°, indicating the possible need for surgery.

They ask for these numbers so that someone cant be accused of misrepresenting surgery rates by using a high COBB angle recomendation for surgery.

Coillard is the first and only (opps, lets not forget Janicki a few pages before her) researcher to report their results in accordance with these criteria.

I have two thiings on my to do list some weekend. I want to compare Janicki and Coillard results (since they both reported using consistent SRS guidelines, it should be straight forward).
and
Since Dr Dolan noted that the Danielson paper (the one "salvaging" the large SRS Bracing study by Nachemson) wasnt published when she wrote her paper, it would be interesting to look at her results including the Danielson data.

Pooka1
02-19-2009, 11:39 AM
What the SRS want to see reported is:

[COLOR="Blue"]b. The percentage of patients who have had surgery recommended/undergone before skeletal maturity (i.e., the time when the orthosis would normally have been discontinued). The surgical indications must be documented.

I'd like to hear a rational defense of this criterion from the SRS or anyone for that matter.

It seems like a proxy for "high rate of curvature." Why not just ask about the rate of curvature instead of layering on a confounder about variation in individual surgeon's opinions about when to pull the surgical trigger?


Coillard is the first and only (opps, lets not forget Janicki a few pages before her) researcher to report their results in accordance with these criteria.

I have never met anyone who did not refer to two articles published in the same issue as "simultaneous publication."

Moreover, as we've seen, adherence to those criteria does not guarantee a quality publication.

txmarinemom
02-19-2009, 02:29 PM
As I'm sure we've discussed before, the distinction between AIS and JIS is sometimes a bit fuzzy. For the purposes of studies Immi is classes as AIS as she was braced a week before her tenth birthday.

However, we know that she is really a JIS case as her curve has been around (and apparently progressing) since she was 7/8...

That's exactly how my curve was, Laura. I was classed AIS because JIS wasn't broken out into its own category in 1978.

In adulthood, I was classed JIS because, as you said, I had an established curve (somewhere in the ±35° range if I remember correctly) a few months before my 10th birthday.

Regards,
Pam

concerned dad
02-19-2009, 03:50 PM
I'd like to hear a rational defense of this criterion from the SRS or anyone for that matter.

It seems like a proxy for "high rate of curvature." Why not just ask about the rate of curvature instead of layering on a confounder about variation in individual surgeon's opinions about when to pull the surgical trigger?


Rate of curvature is a hard thing to measure. To get a rate (as you know) requires two measurements (accurate measurements BTW and COBB angles aren’t inherently accurate to measure – and then you have the inbrace and out of brace thing going on).

Surgery is pretty easy. Either you had it or you didn’t.

And, it makes sense to throw in indications for surgery too.

And, to round things out, throw in the number of patients who progressed beyond 45 degrees (just to rule out any trickery or deception).

The INTENT of these numbers is to assess brace effectiveness. I think these reporting criteria are easier to measure and more meaningful than “rate of curvature”.

Dr. Dolan makes the case that rate of surgery is the only meaningful assessment of bracing effectiveness. So meaningful in fact, that her systematic review excluded the Nachemson study (“failed” 1995 SRS Bracing Study) because it did not include surgical rates. (Yes, there may be other problems with Nachemson, but the surgery thing is why she did not include it).



I have never met anyone who did not refer to two articles published in the same issue as "simultaneous publication."


I know, I forgot to include the wink
;)



Moreover, as we've seen, adherence to those criteria does not guarantee a quality publication.

Well, it may not guarantee a quality publication, but it does guarantee comprarable results. At least we are comparing apples with apples.

About the quality publication thing, last night I read an interesting paper discussing archiving research data, the scientific method and making public policy decisions based on "refereed" literature.
Here is a link if anyone is interested.
due diligence (http://www.fraserinstitute.org/commerce.web/product_files/CaseforDueDiligence_Cda.pdf)

And yeah, the whole AIS, JIS thing seems gray. I wonder why they make the distinction. Must have a good reason I suppose.

Pooka1
02-19-2009, 06:05 PM
Rate of curvature is a hard thing to measure. To get a rate (as you know) requires two measurements (accurate measurements BTW and COBB angles aren’t inherently accurate to measure – and then you have the inbrace and out of brace thing going on).

Surgery is pretty easy. Either you had it or you didn’t.

When you don't have the the protocol of not doing out of brace radiographs, rate of curvature is FAR FAR FAR more robust than whether or not someone has had surgery. This is a self-inflicted problem and is a penetrating glimpse into the obvious.

I don't mean to keep repeating myself but I will... just in this little group we have folks pulling the trigger with a single curve below 50* and folks with double 60+* curves who have had a surgeon suggest they don't need surgery.

If at this point anyone thinks recommendation for, or having, surgery isn't an obvious confound then either you or I am missing some major piece of understanding.


And, to round things out, throw in the number of patients who progressed beyond 45 degrees (just to rule out any trickery or deception).

This is really the only robust criterion among the ones being discussed in this subpart of the thread.


The INTENT of these numbers is to assess brace effectiveness. I think these reporting criteria are easier to measure and more meaningful than “rate of curvature”.

Completely disagree. :D


Dr. Dolan makes the case that rate of surgery is the only meaningful assessment of bracing effectiveness. So meaningful in fact, that her systematic review excluded the Nachemson study (“failed” 1995 SRS Bracing Study) because it did not include surgical rates. (Yes, there may be other problems with Nachemson, but the surgery thing is why she did not include it).


Does she defend that in print?

concerned dad
02-19-2009, 06:53 PM
Does she defend that in print?

Yes, Dolan does. I dont have the paper in front of me but I'll try to quote it.
She says "who the heck cares if the curve progresses beyond a number. What people really care about is will bracing prevent surgery".

Not sure if that is a totally accurate quote :o but I'll amend it tomorrow if necessary.

She discusses at some length WHY the indication for surgery is important in assessing bracing efficacy. Heck, look at the title of her paper.

Regarding the robustness of "rate of curvature". Just how many xrays do you think it would take to determine the variation in that rate?

Pooka1
02-19-2009, 07:18 PM
Yes, Dolan does. I dont have the paper in front of me but I'll try to quote it.
She says "who the heck cares if the curve progresses beyond a number. What people really care about is will bracing prevent surgery".

Not sure if that is a totally accurate quote :o but I'll amend it tomorrow if necessary.

Yes but how valuable is that information if there is no objective standard for surgery? How do you explain the wide range in angles that trigger surgery?


She discusses at some length WHY the indication for surgery is important in assessing bracing efficacy. Heck, look at the title of her paper.


I'd like to see how she fields the issues I brought up. Maybe I'm missing something. This is her field, not mine.


Regarding the robustness of "rate of curvature". Just how many xrays do you think it would take to determine the variation in that rate?

AFAIK, a common protocol is twice a year. Isn't Spinecor three times a year?

That would be enough or at least far, far, far better than the number of folks who had surgery, some of whom had a single 50* curve and some of whom had double 70* curves. I consider the percentage who have surgery a worthless statistic unless all surgeons are using the identical standard which we know a priori just from this little group they are not.

concerned dad
02-20-2009, 09:18 AM
OK, maybe my quote above wasnt entirely verbatim. Funny, she doesnt use the word 'heck' anywhere.

Here is what Dolan has to say about it in her 2007 Spine paper.

Patients and families don’t generally fear curve progression; they fear curve progression to the point where surgery is the only option to improve or maintain an acceptable level of cosmesis. Therefore, it is not surprising that many opt for orthotic treatment without seriously considering the approach of watchful waiting advocated by Dickson and Weinstein in England56 and Goldberg et al57 in Ireland. Unfortunately, orthotic treatment is not necessarily benign in terms of the psychosocial and body image concerns it causes for many families.

Therefore, we think that such a treatment decision should be based on the best evidence available concerning the rate of surgery with and without treatment, including the patient and treatment characteristics that contribute to higher rates of surgery. This evidence is an integral part of informed choice and should be available to clinicians, patients, and their parents as they contemplate bracing. To date, no systematic review has synthesized this evidence.

The objective of this review is to develop a pooled estimate of the incidence of surgery in untreated patients (treated by observation only) and in brace-treated patients with AIS, as well as for specific risk factors that may significantly affect the prevalence of surgery. Ultimately, the objective of this review is to help clinicians, patients, and parents make informed choices concerning treatment for AIS.

I said earlier that this paper was used to demonstrate that there was not a difference between bracing and observation wrt surgery rates and that this evidence was then used in support of the RCT. This paper was not intended to investigate if bracing affected the curve size. It just looked at whether or not the curve progressed to surgery.

Maybe I'm wrong, but I think if a similar systematic review was performed to assess if bracing affected curve SIZE then the results would have been YES.

So, if Sharon is correct when she says surgery is a poor measure of bracing efficacy, does that mean that the BrAIST RCT is proceeding on weak grounds?

concerned dad
02-20-2009, 01:08 PM
So, if Sharon is correct when she says surgery is a poor measure of bracing efficacy, does that mean that the BrAIST RCT is proceeding on weak grounds?

Here is an interesting viewpoint that I agree with. A fellow made the following post here about 6 years ago.


The early detection and treatment of scoliosis is essential to minimize the affects of this condition and provide patients with healthcare options that are less expensive, less painful and less invasive. Most scoliosis spine specialists agree that surgery should be a last resort and efforts should be taken to keep the curve from reaching 45 degrees.

We need a much more aggressive standard however. It is in the best interest of our adolescent patients to replace the generally accepted wait and see approach with an effective non-operative treatment intervention plan. While there are many unknowns and questions about the effect of, and treatment for, scoliosis there certainly is no evidence to suggest that there is a benefit to a curve getting larger. Furthermore, if bony vertebral deformity begins to develop around 30 degrees, and the probability of continued curve progression in adulthood begins to rise at this level as well, then our focus should be on minimizing the magnitude of the curve in the early stages with a goal of keeping it as much below 30 degrees as possible. In order to achieve this goal however we need significantly more multidisciplinary research and coordination to develop and validate a more effective early intervention treatment plan.
__________________
Best Regards,

JOB

This post (from our host Joe O'Brien) would seem to counter the logic of using Dolans paper as support for BrAIST. Should the goal of intervention be escaping surgery or should the goal be stabilizing (or perhaps w/SpineCor, reducing) curve amplitude?
:confused:

Pooka1
02-20-2009, 01:15 PM
Patients and families don’t generally fear curve progression; they fear curve progression to the point where surgery is the only option to improve or maintain an acceptable level of cosmesis.

Well if that's the concern then they should seek out very, very, very conservative surgeons who pull the trigger only at very, very, very high angles and forget the research on curve progression both before and after maturity.

Primitives fear thunder because they think the gods are angry. This is not best addressed by showing them how to placate the gods. Rather this is best addressed by explaining the actual science behind thunder.

I disagree that there is any problem with most folks understanding the connection between curve progression and curve progression to the point of surgery.

Pooka1
02-20-2009, 01:19 PM
Should the goal of intervention be escaping surgery or should the goal be stabilizing (or perhaps w/SpineCor, reducing) curve amplitude?
:confused:

The goal is to stabilize or reduce the curve to a point that will obviate surgery over the life of a patient in my opinion.

We aren't there yet. We aren't even close.

Pooka1
02-20-2009, 01:29 PM
Look, it's fine to pick a criterion like having surgery. But you first have to make sure all the surgeons you are dealing with have the IDENTICAL protocols for that recommendation.

We know FOR A FACT surgeons differ on this point.

Therefore we know FOR A FACT this criterion introduces noise. A lot of noise. I think it's unpublishable.

If scientists started tailoring their approaches to those that lay people think is important then we would have half the biology/geology journals publishing young earth creationist nonsense (pardon that redundancy).*

* Most polls show about half the US population thinks the earth is a few thousand years old. We are the laughing stock of the world.

concerned dad
02-20-2009, 02:14 PM
Dr. Dolan makes the following statement in her concluding remarks of her Equipoise paper.


It has been suggested that progression to surgery indicates the ultimate failure of bracing treatment. The key question of any future study of bracing, randomized or not, must be: How many patients avoided surgery because of bracing treatment?

I guess I haven’t really given this surgery vs curve progression thing much thought. Are we bracing our kids to avoid surgery or are we bracing our kids to stabilize/reduce their curve? Is there a difference?

The BrAIST study has as its primary outcome measure a Cobb angle of 50 degrees which they use as a proxy for surgery. So, correct me if I am wrong, but consider the following simplification. What if, when all is said and done, the braced kids have an average COBB angle of 30 degrees and the observed kids have an average COBB angle of 48 degrees. And equal numbers from both groups progress to surgery (or over 50 degrees). Would they then conclude that bracing is ineffective?

Is the point of the BrAIST study that, while we indeed have enough scientific information to show bracing ALTERS the natural history of AIS. The question is, does it ALTER the need for surgery?

My dad used to say you didn’t understand a contentious issue unless you could make good arguments from both perspectives. I think I may be heading back to the drawing board with my understanding of this whole thing.

Sharon, you convinced me that we didn’t know if bracing alters the natural history of AIS. Part of that ‘convincing’ was seeing the BrAIST study was underway and me reading (and only partially understanding) the relevant papers. Now, looking back at the papers it seems that they are not arguing that bracing alters the natural history of AIS (in fact, they sort of concede that it does). They argue that bracing doesn’t necessarily reduce the need for surgery.

Wow, I could use a cigarette now. (3 weeks this afternoon)

and yes, that is a very freightening statistic you cite.

Pooka1
02-20-2009, 02:21 PM
I really like your thought processes in this last post. You are synthesizing and coming around to the bottom line in my opinion.

concerned dad
02-20-2009, 02:29 PM
Maybe the Spinecor thread does have something to worry about.

It may just take me 250+ pages to figure this out.

:D

Pooka1
02-20-2009, 04:11 PM
Maybe the Spinecor thread does have something to worry about.

It may just take me 250+ pages to figure this out.

:D

Well you have clarified some things for me with your literature analyses. So maybe we just don't need 250+ pages to crack this nut. :D

That's going to be my excuse if we don't achieve this all-important goal. :cool:

concerned dad
03-12-2009, 12:01 PM
For anyone following along, some of the issues (like weaning) discussed earlier in this thread are discussed in the research forum starting
here (http://www.scoliosis.org/forum/showthread.php?t=8537).

Cat Eyes
03-16-2009, 06:27 AM
right now i am a boston brace wearer and it is correcting my spine but is not comfortbale and does not allow me to wear clothes that are 'COOL'. I want to go with the spinecor but I want to learn the perks, plesures, and the disadvantages. Becuase although non of us want to hear it, there are many disadvantages in EVERY brace, no matter what way we look at it!!!!! so please send me a message back and just talk about the spinecor. I am doing alot of research because i take charge more then my parents do!!

Cat Eyes
Katelyn
13 8th grade
Degree= 30
in brace= 5
Boston brace
Want spine cor

Pooka1
03-16-2009, 08:50 AM
Cat eyes,

I just want to say I admire your spunk. I hope you have ambitious dreams because I think you will do big things in life. :)

sharon

concerned dad
03-16-2009, 09:22 AM
Cat eyes
Dont believe ANYTHING you read on these forums. Everything here is just personal opinions, and they often change.

Having said that,

For you to have a correction to 5 degrees "in brace" suggests that the Boston Brace is doing its' job. I really dont think you could hope for an initial correction like that with the SpineCor.

You are correct, every brace has its' disadvantages, and the SpineCor is no different. There is a lot of marketing hype on the internet for the Spinecor. It is difficult to discern the truth.

Good luck!

Pooka1
03-16-2009, 09:31 AM
Cat eyes
Dont believe ANYTHING you read on these forums. Everything here is just personal opinions, and they often change.

I just want to emphatically agree with CD here.

There are no orthopedic surgeons on this forum. Those are the ONLY people you can hope to get any straight dope from. We have some chiros here but no orthotists. No matter because neither of these groups can be counted on to have any straight dope. They don't have the requisite training.

And given that orthopedic surgeons disagree among themselves, that should alert you to the fact that sometimes, NOBODY knows the right answer. Unfortunately, much of scoliosis treatment is in the category.

AILEA
03-16-2009, 12:18 PM
AILEA - I would be curious to hear why your daughter switched away from the SpineCor. Maybe you could reply here or perhaps more appropriately at the end of the “Why I decided to brace my Daughter with the Spinecor” thread.

C.DAD
A little late, but here you are....

We stopped with the spinecor, because when my dd was wearing it for 15 months, she had an in-brace x-rays, and her curve was as big as in the out of brace x-rays when she was diagnosed . She was 15 years old.
She didn’t have a great reduction when she was fitted(from 38º to 25º), but I think that as my dd was growing and her curve was becoming less flexible, the spinecor wasn’t able to support the spine. That’s why that day we chose to try with the Cheneau.

jillw
03-17-2009, 02:24 PM
Ailea, Just curious, when the in brace xrays showed the in brace curve had increased to approx 38 degrees what were the corresponding out of brace xrays? (I'm guessing they had to take an out of brace xray to fit the cheneaux brace?) Also, how much time passed between the in brace xray of approx 38 and the next out of brace? How is the cheneaux working so far? Good luck with it. Thanks!