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Why I decided to brace my daughter with the SpineCor

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  • #61
    Concerned Dad;

    How is your daughter adjusting to the brace?
    from Boston, MA, USA

    9 y.o. daughter
    07/08 - diagnosed with L23
    10/08 - wait and see: L25
    11/08 - Spinecor: L15
    01/09 - Spinecor: L15
    06/09 - Spinecor: L14
    11/09 - Spinecor: L14
    04/10 (Out-of-brace): L30-T30
    08/10 - out of Spinecor
    01/11 (Out-of-brace): L42-T30
    02/11 - Rigo-Cheneau and Schroth

    Comment


    • #62
      Just wondering...

      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!
      71 and plugging along... but having some problems
      2007 52° w/ severe lumbar stenosis & L2L3 lateral listhesis (side shift)
      5/4/07 posterior fusion T2-L4 w/ laminectomies and osteotomies @L2L3, L3L4
      Dr. Kim Hammerberg, Rush Univ. Medical Center in Chicago

      Corrected to 15°
      CMT (type 2) DX in 2014, progressing
      10/2018 x-rays - spondylolisthesis at L4/L5 - Dr. DeWald is monitoring

      Click to view my pics: pics of scoli x-rays digital x-rays, and pics of me

      Comment


      • #63
        Recent study on quality of life, brace compliance

        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

        Comment


        • #64
          Welcome back, Concerned Dad

          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.

          Originally posted by concerned dad View Post
          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.
          Last edited by Pooka1; 01-22-2009, 06:28 PM.
          Sharon, mother of identical twin girls with scoliosis

          No island of sanity.

          Question: What do you call alternative medicine that works?
          Answer: Medicine


          "We are all African."

          Comment


          • #65
            The "right" direction

            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.
            Sharon, mother of identical twin girls with scoliosis

            No island of sanity.

            Question: What do you call alternative medicine that works?
            Answer: Medicine


            "We are all African."

            Comment


            • #66
              Originally posted by Susie*Bee View Post
              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.
              Sharon, mother of identical twin girls with scoliosis

              No island of sanity.

              Question: What do you call alternative medicine that works?
              Answer: Medicine


              "We are all African."

              Comment


              • #67
                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
                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

                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.

                Comment


                • #68
                  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.
                  Sharon, mother of identical twin girls with scoliosis

                  No island of sanity.

                  Question: What do you call alternative medicine that works?
                  Answer: Medicine


                  "We are all African."

                  Comment


                  • #69
                    I thought you would like those web pages. I had to do a double take to be sure it wasnt your webpage.

                    Comment


                    • #70
                      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. )

                      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.
                      Sharon, mother of identical twin girls with scoliosis

                      No island of sanity.

                      Question: What do you call alternative medicine that works?
                      Answer: Medicine


                      "We are all African."

                      Comment


                      • #71
                        Originally posted by concerned dad View Post
                        (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.
                        Sharon, mother of identical twin girls with scoliosis

                        No island of sanity.

                        Question: What do you call alternative medicine that works?
                        Answer: Medicine


                        "We are all African."

                        Comment


                        • #72
                          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?

                          Comment


                          • #73
                            Same guy

                            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.

                            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.
                            Sharon, mother of identical twin girls with scoliosis

                            No island of sanity.

                            Question: What do you call alternative medicine that works?
                            Answer: Medicine


                            "We are all African."

                            Comment


                            • #74
                              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.

                              Comment


                              • #75
                                Originally posted by concerned dad View Post
                                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?
                                Sharon, mother of identical twin girls with scoliosis

                                No island of sanity.

                                Question: What do you call alternative medicine that works?
                                Answer: Medicine


                                "We are all African."

                                Comment

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