TSRH research shows that bracing IS effective!

[skevimc]

How do you think this will change how surgeons talk to patients if you think it will change how they talk to patients?

I think people/doctors will read this article and interpret based on their current bias. Your assertion is that the huge variation in the study will not let doctors claim absolute effectiveness. And I'm saying that nothing has absolute effectiveness. Or at least, that's what I was asking, if anything claims absolute effectiveness. (Other than CLEAR of course.)

Yes that is technically true but I think folks think this study provides better predictive power than it does.

No doubt that what you are saying is true. But that's true with most studies, i.e. bias. This study is a pretty good one in that it is a prospective trial that does a great job of controlling for time in brace. They don't do a lot of tricks with their data to get the basic result, which is that the brace seems to have altered progression based on daily wear. Certainly more can be presented. The data can be stratified in a dozen different ways that will have various implications.

I guess my overall point with this study is that, out of a lot of crap that has been published, this study is a good one. It's certainly better than this.

http://scoliosis.org/forum/showthread.php?t=10027

And if everybody is being honest with their opinions and critiques of these two articles, it's clear where our biases are.

However, I will also say that I don't like bracing as an option. Some girls seem to handle it fine but others clearly don't. In fact, the impetus for the doctors funding the torso strength study was to find an alternative to bracing. But I digress.

No I wasn't referring to that bar graph as complex. Bars graphs are simplicity itself. I was referring to your comments and those of the commentary.

I guess I was assuming, based on your comment, you were implying that they needed a complex statistical concept to 'eke' out a small result. The logarithmic curves were definitely complex and to me have fairly little to offer other than identifying future directions, e.g. most effective time of day for bracing.

Isn't that the claim of bracing and the reason why adults are not braced?

I don't know. Certainly growth spurt is a major part of it but I think skeletal maturity gets as much credit. I think overall it's based on the apparent moldability of the bones.

[Pooka1]

I think people/doctors will read this article and interpret based on their current bias. Your assertion is that the huge variation in the study will not let doctors claim absolute effectiveness. And I'm saying that nothing has absolute effectiveness. Or at least, that's what I was asking, if anything claims absolute effectiveness. (Other than CLEAR of course.)

Yes but some results have a lot less variation that that for heavens sake.

LOL on the Clear comment! You rock.

I guess my overall point with this study is that, out of a lot of crap that has been published, this study is a good one. It's certainly better than this.

http://scoliosis.org/forum/showthread.php?t=10027

Is the article available anywhere for free?

ETA: I mean the TSRH article, not the one you linked.

However, I will also say that I don't like bracing as an option. Some girls seem to handle it fine but others clearly don't. In fact, the impetus for the doctors funding the torso strength study was to find an alternative to bracing. But I digress.

Do you think this article is enough to immediately halt BRAIST on ethical grounds? Do you think the authors think so? I suspect not.

I guess I was assuming, based on your comment, you were implying that they needed a complex statistical concept to 'eke' out a small result. The logarithmic curves were definitely complex and to me have fairly little to offer other than identifying future directions, e.g. most effective time of day for bracing.

I haven't seen the article or the log curves but you have peaked my interest. That is going to be an area of scrutiny.

I don't know. Certainly growth spurt is a major part of it but I think skeletal maturity gets as much credit. I think overall it's based on the apparent moldability of the bones.

I apparently don't have these concept clear in my mind. Isn't it the case that skeletal maturity is basically the end of the adolescent growth spurt? I mean what do you think the point of mentioning that was in the commentary?

On another topic, I can't for the life of me find the prevalence of various types of curves in the AIS population. The Lenke study shows the prevalence of surgical curves but we need to know both pieces of information.

For example if half of T curves become surgical but 99% of double majors become surgical then this study might be a worst case given that double majors dominate to study cohort. But we would have to assume the Boston brace addresses both curve types with the same efficiency.

[skevimc]

Is the article available anywhere for free?

ETA: I mean the TSRH article, not the one you linked.

Since I don't think the study was funded by NIH it's not covered under open access. It's possible if you wrote Katz directly he might send you a copy. I know anyone that contacts me I always send my stuff along whether they want it or not. It's my attempt at indoctrination.

BTW, what does ETA mean? I've seen you use it about 1000 times and I've thought and thought and thought about it and I can't figure it out.

Do you think this article is enough to immediately halt BRAIST on ethical grounds? Do you think the authors think so? I suspect not.

I honestly don't know enough about the BRAIST study. I've seen you all talk about it a lot on here but don't know a thing about it.

I apparently don't have these concept clear in my mind. Isn't it the case that skeletal maturity is basically the end of the adolescent growth spurt? I mean what do you think the point of mentioning that was in the commentary?

You can be done growing, but the growth spurt isn't something that can be prospectively measured. It's only possible to see it in retrospect. Whereas you can look at risser and TRC to see what the so called skeletal age is. This is when you have a 15 year old who is 2 years post menarchal but has a risser 1 or 2 but closed TRC. She's probably not going to grow anymore, but her growth plates haven't closed yet so things are still 'moldable'. So the biomechanical forces that influence scoliosis can still cause problems. Essentially, the risser and TRC are quantifiable from a progression stand point. The growth spurt is only quantifiable in retrospect and thus provides little prognostic value. Unless they keep careful height records at each 4 month visit. In which case you could see the height velocity. But still, there's a lot of variability.

On another topic, I can't for the life of me find the prevalence of various types of curves in the AIS population. The Lenke study shows the prevalence of surgical curves but we need to know both pieces of information.

For example if half of T curves become surgical but 99% of double majors become surgical then this study might be a worst case given that double majors dominate to study cohort. But we would have to assume the Boston brace addresses both curve types with the same efficiency.

The lonstein and carlson paper has progression risk for various curves. There was another study that was discussed on here a few months ago that had progression risk of various curves. I might be able to find it.

[Pooka1]

BTW, what does ETA mean? I've seen you use it about 1000 times and I've thought and thought and thought about it and I can't figure it out.

Edited to add. It alerts the two or three people who read my posts that I made a change.

I honestly don't know enough about the BRAIST study. I've seen you all talk about it a lot on here but don't know a thing about it.

It's a prospective controlled bracing studying with about 20 medical centers participating. That's 20 medical centers who agree it is ethical to randomize kids to a control group.

You can be done growing, but the growth spurt isn't something that can be prospectively measured. It's only possible to see it in retrospect. Whereas you can look at risser and TRC to see what the so called skeletal age is. This is when you have a 15 year old who is 2 years post menarchal but has a risser 1 or 2 but closed TRC. She's probably not going to grow anymore, but her growth plates haven't closed yet so things are still 'moldable'. So the biomechanical forces that influence scoliosis can still cause problems. Essentially, the risser and TRC are quantifiable from a progression stand point. The growth spurt is only quantifiable in retrospect and thus provides little prognostic value. Unless they keep careful height records at each 4 month visit. In which case you could see the height velocity. But still, there's a lot of variability.

Okay I think I understand that (not sure!).

What I'm asking is the following:

1. Did they miss the growth spurt for a majority of the study subjects (determined any way you like)?

2. Is skeletal maturity typically achieved soon after the end of the growth spurt?

The lonstein and carlson paper has progression risk for various curves. There was another study that was discussed on here a few months ago that had progression risk of various curves. I might be able to find it.

What I don't understand is why this study was so loaded with double majors when they are not the most prevalent curve type which thoracic, both in general prevalence and surgical prevalence.

These can't be consecutive cases... they must have selected in a way that over-represented double majors w.r.t. their prevalence in the general population and in the surgical population. Now if double majors have a higher risk then that would make the study stronger given they have so many double majors. But then they have to assume the brace works with the same efficient on double majors and T curves. They would have to show that at some point... maybe they did. Did they show any data where curve type is broken out?

I may toddle over to a medical library and try to get the paper.

[mariaf]

It alerts the two or three people who read my posts that I made a change.

You crack me up, Sharon. I'll go out on a limb and say the number is somewhat higher than two or three - LOL!

[michael1960]

Well, it took some time this morning to read through all the comments on this thread. Very interesting discussion. I would like to add just a few points:

1. My daughter is almost 9 diagnosed when she was 7 1/2 (23 deg) and no treatment started until she was 8 (36 deg). She increased from 23 deg to 36 deg in 4 month period. The worse curve was T4-T12. (OCT 2009)

2. We started with SpineCor brace (recommendation from Children's Hospital pediatric orthopedic surgeon). Couple months later the T4-T12 curve was down to 30 deg. (JAN 2010)

3. We followed up with an intensive 2-week physical therapy session (8 hours per day). The T4-T12 curve was reduced to about 24 deg but the T5-T12 curve remained around 30 deg. (JAN 2010)

4. Couple months later she started wearing the Boston brace (recommendation from a VBS doctor). The T4-T12 was at 24 deg and the T5-T10 was about 30 deg (we maintained the curve improvements from the 2 week intensive physical therapy). My daughter wore the SpineCor to school and all sporting events and the Boston brace at night. This helps with brace compliance. Her "in brace" measurement was about 18 deg in the SpineCor and 13 deg in the Boston brace. (MAR 2010)

5. Three months later the T5-T10 (worse curve) was about 22 deg (out of brace 48 hours) and the T4-T12 was down to about 18 deg (out of brace 48 hrs). Her Boston "in brace" measurement was about 9 deg. (JUN 2010)

6. We did another two weeks of intensive physical therapy and the T5-T10 curve was reduced to about 18 deg (out of brace 48 hrs) and her Boston "in brace" measurement was reduced to about 3 deg (JUN 2010)

7. She is now wearing the SpineCor brace during the day, the Boston brace at night, and doing about 1-2 hours of physical therapy (at home) each day. We will continue this for the next 2-3 months until she has her next x-ray.

I assume most of this research discussion is regarding AIS research but for anyone reading this thread curve reduction (not only curve stabilization) is possible for JIS. I was told by several pediatric orthopedic surgeons that curve reduction was not possible.

In February 2010 my daughter was a candidate for VBS (staples with hybrid growing rod) but she is now not even considered a VBS (staples only) candidate anymore because she is below 25 deg and showing continued curve reduction.

We are at a very difficult point because on one hand we wanted VBS. We were working hard to get the curve down to 25 so she would be a VBS (stapling only, no hybrid rod) candidate. Now, being below 25 and showing curve reduction, she is no longer a VBS candidate. We truly felt VBS was the right decision (internal brace through skeleton maturity and maybe some benefits having an internal brace through adult life).

Now, a VBS doctor is suggesting that she do bracing instead (a plan I recommended back in February and was told it would not work). We are going to give bracing a chance, see how much reduction we can get, and monitor it closely so she does not bounce back up to 30+ and no longer be a VBS candidate (staples only). I was wondering whether his recommendation was based on some new study.

Of course, the big concern is that there are very few, if any, studies that support or show a reduction in a JIS curve (from 35+ to 15 deg) will remain stable with part-time/full-time bracing through skeleton maturity and beyond into adult life. The VBS doctor did say there were some studies that showed if a curve is reduced to 15-20 deg at skeleton maturity that it would not progress in adult life. I need to find this study (will be requesting from the VBS doctor). In addition, I wonder if that study was based on any JIS children who had already reached 35+ degrees, before reaching 15-20 deg through bracing. That would make it relevant, otherwise, probably not relevant.

One other comment. While I am a very big supporter of following the doctor's advice, the treatment we are following has not been recommended or suggested by any doctor. One says to wear the SpineCor. One says to wear the Boston brace. None, for the most part, support the wearing of two braces. And none, for the most part, see much benefit in physical therapy. We have seen at least 4 pediatric orthopedic surgeons, two chiropractors, and 4 orthotists (all specializing in scoliosis), who all have a different opinion on what works. And in most cases most of them do not support the other's recommendations.

And it is unfortunate, there are many young children who are at great risk of curve progression, who are following the advice of their doctor or some other scoliosis practitoner, who will never know of any other treatment, because his/her doctor does not believe in it, or is not familiar with it. I recently met two girls, one 9 with a 45 deg curve and another 12 with a 40 deg curve (both with curves progressing since last x-ray). The parents had never heard of VBS as an option and the pediatric orthopedic surgeon and chiropractor treating them never mentioned it to them. These are two girls who are on their way to spinal fusion. If they went to a VBS doctor they would both be considered a high priority.

While I have read many many research papers, I put a lot of trust in other parents who are getting results with different treatments. It is a very difficult balancing all the advice from: pediatric orthopedic surgeons, chiropractors, orthotists, physical therapists, other parents, forums, research papers, etc..

Again, very good discussion regarding bracing.

Thanks
Michael

[Pooka1]

In this study, 50 progressed and 50 were stable.

Wouldn't it potentially be the hot ticket if someone determined a Scoliscore for all these patients?

[Ballet Mom]

skevimc-

I don't think anyone on this site or involved with scoliosis "likes" bracing as an option. In fact, I can't think of a medical procedure or medical device that I like. Unfortunately, people have yucky medical procedures and medical devices used all the time. Fortunately, bracing is not permanent.

The Braist study is trying to prove that bracing doesn't work, so that bracing can no longer be shown as the standard of care in scoliosis treatment. Therefore, insurance companies won't have to pay for braces anymore and the medical profession will just let scoliosis curves continue to increase in size and stop naturally and rely on most curves not reaching surgical level...but at an increased deformity and more likelihood of progressing as an adult.

A great cost savings for the medical insurance industry.

The great thing about this study by Texas Scottish Rite is that it shows that bracing is effective. It will be much more difficult for insurance companies to abandon the practice of paying for scoliosis bracing, if not impossible.

There is no one that is forcing anyone to brace their child. But there are those who would like to force one treatment on everyone elses children.

[Pooka1]

The Braist study is trying to prove that bracing doesn't work, so that bracing can no longer be shown as the standard of care in scoliosis treatment.

FALSE. And scandalous.

[Pooka1]

Purpose fo Braist

The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.

http://clinicaltrials.gov/ct2/show/NCT00448448

[Pooka1]

You crack me up, Sharon. I'll go out on a limb and say the number is somewhat higher than two or three - LOL!

It gets worse... I refer to these two-three people as my imaginary buddies.

[Ballet Mom]

FALSE. And scandalous.

There are people who disagree with you.

[skevimc]

Edited to add. It alerts the two or three people who read my posts that I made a change.

Got it. Thanks.

It's a prospective controlled bracing studying with about 20 medical centers participating. That's 20 medical centers who agree it is ethical to randomize kids to a control group.

Man, this is huge. I see that the end is August 2010. I'd imagine it will take a year or two for any publications but I bet the conferences will start lighting up with results.

What I'm asking is the following:

1. Did they miss the growth spurt for a majority of the study subjects (determined any way you like)?

2. Is skeletal maturity typically achieved soon after the end of the growth spurt?

1. According to the commentary they did. I'm sure the text discusses it as well. But all patients were still skeletally immature.

2. I'm not sure what the time difference is between the cessation of vertical growth and full skeletal maturity.

I think the overall point is that 60% of patients were on the down slope of their height velocity. So they still had growth (because <1cm of growth in 6 months was an endpoint), but they weren't in their major growth spurt which is usually 6-13 cm/yr.

What I don't understand is why this study was so loaded with double majors when they are not the most prevalent curve type which thoracic, both in general prevalence and surgical prevalence.

These can't be consecutive cases... they must have selected in a way that over-represented double majors w.r.t. their prevalence in the general population and in the surgical population. Now if double majors have a higher risk then that would make the study stronger given they have so many double majors. But then they have to assume the brace works with the same efficient on double majors and T curves. They would have to show that at some point... maybe they did. Did they show any data where curve type is broken out?

The Lonstein paper has double majors progressing at the same rate as single T. And I just found the other study. You actually posted it (Soucacos et al 1998) A 5-year prospective study of 85,622 kids found 1,436 kids with scoliosis.. The incidence of progression for double curves is the same as single T curves as well. Both around 23%

I'm assuming they were consecutive "intent-to-treat" patients that met all of the criteria. If T curves were filtered out it would have been because of any number of exclusion criteria. Mainly, undiagnosed AIS and previous orthotic use.

I could not find if they broke the curve types down based on progression or surgery. This would be very interesting to see.

I may toddle over to a medical library and try to get the paper.

Probably a good idea. Reading the article definitely helps with interpretation.

[Pooka1]

There are people who disagree with you.

There are people who insist they were abducted by aliens also.

[hdugger]

The Braist study is trying to prove that bracing doesn't work, so that bracing can no longer be shown as the standard of care in scoliosis treatment. Therefore, insurance companies won't have to pay for braces anymore and the medical profession will just let scoliosis curves continue to increase in size and stop naturally and rely on most curves not reaching surgical level...but at an increased deformity and more likelihood of progressing as an adult.

I haven't loved that study (I complained in the past that they seemed to be monkeying with some of the requirements), but I have to defend my fellow MPh's and state that they're not *trying* to change the standard of care. They're trying to figure out if the standard of care is effective. That's always a reasonable thing to do, and this kind of research has been tremendously helpful in showing, for example, that physical therapy is just as good as surgery for most common back problems.

BTW, I'm not actually entirely in favor of bracing, personally. But I'd never recommend that someone else's child not be braced if that's what their doctor recommends. If people want to make their own counter-doctor decisions for their own child - well, that's what being a parent is all about. But recommending that *other* children ignore doctor's advice is out of our realm of expertise.

ADDED: "It's (BRAIST) a prospective controlled bracing studying with about 20 medical centers participating. That's 20 medical centers who agree it is ethical to randomize kids to a control group." I don't believe the study is randomized now. I think they changed their protocol part of the way through, and they're still calling it randomized, but it's not really.