Scoliosis Specialists

[Pooka1]

Christine,

Has your daughter had an out of brace xray since starting the Spinecor? Those results are amazing!

Someone made a claim a while back on the Spinecor thread I think that is has been determined that all out of brace progressions are always accompanied by in-brace progressions.

I'd like to see the database for that claim but if true, then out of brace radiographs are not needed. It would be more believable if it is at least published though it could still be false.

[emarismom]

Sharon,

That is exactly what I have been told, that the in brace x-rays should reflect what the curve is doing. While I doubt that there could be any type of progression of a curve when in brace xrays are all getting lower, if after two years of bracing, an out of brace xray is done and the curve is stable or close to its original state, it could be very disheartening.

My ortho has also been insistent that I have an out of brace xray, so I had one 6 months ago and used that with the chiro. This time I had an in brace and used that with the ortho. Next time I get an xray, around late May or June, I will get an out of brace to accomodate the ortho.

[concerned dad]

But how would you know the pill could almost certainly cure the illness without studies? With such stark results, clinical trials are usually halted and the control group is given the pill.
sharon

you mean like this? Emphasis added at the bottom is mine

INTERIM RESULTS OF A PROSPECTIVE RANDOMISED STUDY OF THE NATURAL
HISTORY OF IDIOPATHIC SCOLIOSIS VERSUS TREATMENT WITH THE SPINECOR
BRACE.
The objective of this prospective randomised study was to compare the natural history of Idiopathic Scoliosis patients to
those treated with a SpineCor brace with a Cobb angle between 15 and 30 degrees. A cohort of 65 patients were
randomly assigned to a control non-treated (n=36; age=12 years; Cobb angle:20±5 degrees) or treated group with the
SpineCor brace (n=29; age=12 years; Cobb angle : 22±5 degrees). Inclusion criteria included an initial Cobb angle
between 15 and 30 degrees, Risser 0, 1 or 2, high risk of progression (increase of Cobb angle of 5 degrees or more within
the last 6 months), girl or boy and no significant malformation of the spine. Each patient underwent a comprehensive
evaluation (radiological and clinical) prior to commencing the study, at 4 month intervals during treatment and follow-up.
From both groups there were 3 patients who withdrew. For the remaining 33 control subjects there was a mean Cobb
angle of 26±8 degrees and for the treated group, 20 are still in treatment with a mean Cobb angle in brace of 15±7
degrees. The remaining 6 patients, in the treated group, have been weaned from the brace but for less than 1 year.
Table 7 : Percentage of patients improved, stable and worsened at the last available visit.

..................Improved.......Stable.......Wors ened
Control (n=33) 12.............45...............42
Treated (n=20) 76.............14................5

This is the first prospective randomised study on Scoliosis patients investigating the Cobb angle between 15 and
30 degrees. This interim evaluation reveals a strong tendency where 42 percent of the control group worsen,
compared to the treated group who showed a worsening of only 5 percent. This interim result which shows this large
difference in worsening between treated and non-treated patients questions the logic of continuing this prospective
randomised study.

[Pooka1]

That looks promising but always think about possible flaws in study design. Can you post the source?

Where is this published? Who is doing the study? How long has the study be going on?

The main question I have is are braced angles which show improvement or stability in-brace? I mean of course the curve will be less in a brace. Am I missing something? I realize we have claims that all out of brace progression is always accompanied by an in-brace progression but I don't think that has been shown, rigorously or otherwise.

The main problem I see is why is the treated group at this point so much smaller than the control group? Each group lost three but then another 6 are unaccounted for in the treated group. What happened to them and what is their Cobb angle at the end of the bracing and at the end of the weaning? I can't think of a good scientific reason not to include those subjects in the brace stats. If they had been included, might the results be different? With this small a study, it seems likely those six (about a 1/3 of the present number and about 1/4 of the real total if they didn't go missing) can skew the results towards something else. The lack of inclusion of these 6 subjects is consistent with my conjecture that the bracing stats are in-brace because then it would be apples and oranges to include the weaned patients with the in-brace patients.

If it's in-brace then the study is very limited until we know the course of patients after bracing.

Also, the average of the control subjects is thought to be a stable angle as far as I know. So no treatment is looking pretty good (more than half the subjects).

I also want to know the distribution of angles in each group and if there was any data selection prior to inclusion. That is, although subjects were assigned randomly, I wonder if the angles ended up being randomly distributed between the groups. I want to know how the randomization was done.

I also wonder why the groups didn't start out as the same size or closer than they were. There is some non-randomness being introduced somewhere.

On the whole, I see opportunity for data selection at a few points which is going to compromise the results if true.

[concerned dad]

That looks promising but always think about possible flaws in study design. Can you post the source?

Where is this published? Who is doing the study? How long has the study be going on?

I found it buried in the SRS.org website in the professional section.

All your points and questions are valid. It doesnt look like this has been published, it is preliminary (although I dont speak french).

I just wanted to share it as a possible example of a random controlled study on scoliosis bracing that was apparently stopped due to ethical concerns.

You got me interested in looking what we do know about controlled studies.
here is another one. PubMed truncates the abstract at 250 words. That's too bad because the most important conclusion from this "randomized" (I use quotes because it isnt truly randomized) is at the end. Again, emphasis added is mine. This isnt found in its' entirety at Pubmed, i got it from a french website.

Titre du document / Document title
Effectiveness of TLSO bracing in the conservative treatment of idiopathic scoliosis
Auteur(s) / Author(s)
FERNANDEZ-FILIBERTI R. ; FLYNN J. ; RAMIREZ N. ; TRAUTMANN M. ; ALEGRIA M. ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
Univ. Puerto Rico, hosp. Puerto Rico, dep. orthopedic surgery, San Juan Puerto 00936-5067, ETATS-UNIS

Résumé / Abstract
A clear understanding of the effectiveness of the thoracolumbosacral orthosis (TLSO) as a conservative treatment for idiopathic scoliosis is still necessary. In the past few years, the review of pertinent literature has emphasized the lack of properly matched control studies and erroneous interpretations of results due to the use of univariate analysis. Also, in a previous controlled study evaluating the bracing of idiopathic scoliosis, the researchers mixed different types of braces and patients. Therefore, their findings were not specific to any kind of orthosis. In our study, we responded to these criticisms by providing a homogeneous group of patients with a control group and by conducting a multivariate analysis to assess the effectiveness of the TLSO. All the patients at the University Pediatric Hospital Scoliosis Clinic aged 8 through 15 with initial Cobb's angle between 20 and 40° and evidence of progression were assessed. All the patients who used the TLSO and showed full compliance with treatment (n = 54) were compared with a control group. The control group consisted of the patients who needed the treatment with the brace but did not use it for several reasons (n = 47). Neither group showed significant differences in sex, initial age, initial Cobb's angle, menarche, Risser sign, or curve pattern. The mean follow-up period was 3.3 years after skeletal maturity. The results were analyzed using a multivariate analysis because the natural history of scoliosis is determined by multiple factors. The analysis showed that the control group had a threefold increase in the odds of ending with surgery compared to the treatment group (OR = 3.24, 95% CI, 1.09-9.60). The curve was more likely to progress >40° in the control group (OR = 2,83, 95% CI, 0.98-8.17)

[concerned dad]

and it is a good thing Nutty is a good sport because we totally hijacked this thread.

[Pooka1]

Titre du document / Document title
Effectiveness of TLSO bracing in the conservative treatment of idiopathic scoliosis
Auteur(s) / Author(s)
FERNANDEZ-FILIBERTI R. ; FLYNN J. ; RAMIREZ N. ; TRAUTMANN M. ; ALEGRIA M. ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
Univ. Puerto Rico, hosp. Puerto Rico, dep. orthopedic surgery, San Juan Puerto 00936-5067, ETATS-UNIS

Résumé / Abstract
A clear understanding of the effectiveness of the thoracolumbosacral orthosis (TLSO) as a conservative treatment for idiopathic scoliosis is still necessary. In the past few years, the review of pertinent literature has emphasized the lack of properly matched control studies and erroneous interpretations of results due to the use of univariate analysis. Also, in a previous controlled study evaluating the bracing of idiopathic scoliosis, the researchers mixed different types of braces and patients. Therefore, their findings were not specific to any kind of orthosis. In our study, we responded to these criticisms by providing a homogeneous group of patients with a control group and by conducting a multivariate analysis to assess the effectiveness of the TLSO. All the patients at the University Pediatric Hospital Scoliosis Clinic aged 8 through 15 with initial Cobb's angle between 20 and 40° and evidence of progression were assessed. All the patients who used the TLSO and showed full compliance with treatment (n = 54) were compared with a control group. The control group consisted of the patients who needed the treatment with the brace but did not use it for several reasons (n = 47). Neither group showed significant differences in sex, initial age, initial Cobb's angle, menarche, Risser sign, or curve pattern. The mean follow-up period was 3.3 years after skeletal maturity. The results were analyzed using a multivariate analysis because the natural history of scoliosis is determined by multiple factors. The analysis showed that the control group had a threefold increase in the odds of ending with surgery compared to the treatment group (OR = 3.24, 95% CI, 1.09-9.60). The curve was more likely to progress >40° in the control group (OR = 2,83, 95% CI, 0.98-8.17)

Thanks for posting this. What is the year?

I realize it is just an abstract but there are far more troubling aspects in this study than in the previous one. Taking a criteria of being having actually had surgery is obviously problematic. There are people here with double curves over 60* who don't have surgery and some who have a single 50* angle who have surgery. Surgery is a nonsense criteria in scoliosis studies in my opinion.

Also, the likelihood of progression to >40* is going to be controlled largely by the angle at the beginning of study, not any bracing or not bracing. Your point about this not being a true randomized study comes into play here. I would want to see the actual distribution of angles in each group when the group is this small. Unless the groups are large, this matters.

[concerned dad]

Sharon, earlier we discussed:
Quote:
Originally Posted by concerned dad
There are very very few controlled studies (where the control is Sharon's definition of an unbraced group).

I would say it's the general definition for a control group;

You are correct, it would make sense that an unbraced group would be a control group, This Fernandez paper shows in part what I was trying to say. There was a control group here, but it was made up of people who refused treatment. Obvious potential problems w/that (although they say the two groups were similar in many characteristics) Another paper used as their "control" (and got "points" in the meta analysis for being randomized) two groups of patients who were randomly assigned two different braces. I know thats not what you mean when you call for a randomized controlled trial.

There is very little information out there about unbraced scoliosis progression.

This Fernandez paper was from 1995. I cant get the full text online unfortunately, my online access to that journal is only available after 1996.

But there is something else I want to share with you and solicit your opinion on. The meta analysis paper we discussed had a real interesting comment in the discussion about what happens to their results if they exclude just ONE study (I think the Ireland study). It's pretty interesting, but will have to wait till tomorrow.

[Pooka1]

I'm coming to realize you are correct about very little data for natural history. These unbraced folks are out there... I don't know why someone doesn't capture those data.

I have read recently at least one study with a control group of over 70 people. That's getting to be real numbers but still should be much, much larger.

Happy Holidays to everyone. Here's hoping the next year brings forth oodles of dispositive research studies!

[FixScoliosis]

sorry for jumping in like this.

here is an abstract of a article that might be of intrest in the discussion of bracing

Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review.

Dolan LA, Weinstein SL.
Spine. 2007 Sep 1;32(19 Suppl):S91-S100. Review.


CONCLUSION.: Comparing the pooled rates for these two interventions shows no clear advantage of either approach. Based on the evidence presented here, one cannot recommend one approach over the other to prevent the need for surgery in AIS. This recommendation carries a grade of D, indicating that the use of bracing relative to observation is supported by "troublingly inconsistent or inconclusive studies of any level." The decision to brace for AIS is often difficult for clinicians and families. An evidence-based estimate of the risk of surgery will provide additional information to use as they weigh the costs and benefits of bracing.

[Pooka1]

Hey FixScoliosis, you are welcome to jump in anytime in any thread in my book. You are data- and evidence-driven. That is not so common.

Thanks for posting that. I think that has been posted upthread.

The only proven treatment modality as far as I know is fusion surgery. Some of the other non-fusion surgical techniques are gathering data and look promising.

[concerned dad]

The paper that fixscoliosis referenced is the one I wanted to discuss with Sharon.
I thought it best to post my comments on the

other thread

[txmarinemom]

10/08 1 degree!!! or as Dr Rivard said "it might as well be 0"

Christine, I have to ask, why are you - and Rivard - even bracing a child with a 1° curve?

[christine2]

Because she is only 8 yrs old. The Spinecor reduced her curve and we (her father & I) have chosen to keep her in brace thru her growth spurt. We could prob. take her out for a few years. But because it is so easy to wear & It has had no emotional effects on her, we are going to play it safe. We have given my daughter more flexability but she wants to still wear it full time.

[concerned dad]

......but she wants to still wear it full time.

Wow!
correcting from 33 degrees to 1 degree with a brace a child not only tolerates but prefers to wear. What a success story. I know each child is different but that is very inspiring.
Is it fair to say that this would not have happened w/o a brace?
Is it also fair to say that this correction would not have happened with a different brace?

I am guessing you're not out of the woods yet as she still has several years to go before her major growth spurt. But I bet you feel pretty good about the decisions you've made along the way.
May all our children be as fortunate.