Why I decided to brace my daughter with the SpineCor

[concerned dad]

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 and Here 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.

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]

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]

Wow...great summary

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]

Haleysmom

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

That was a good post, wasn't it.

[Pooka1]

Concerned Dad!

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

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

[Pooka1]

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]

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]

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]

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]

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]

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]

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]

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]

(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]

Wow, you're really going to hold my feet over the coals on this.
I like it.
Good points that deserve to be hashed out.
I'm going to need some time though

gotta keep in mind that 10% Utah thing