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Thread: Another Brace Study

  1. #1
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    Another Brace Study

    http://www.ncbi.nlm.nih.gov/pubmed/20516309

    J Bone Joint Surg Am. 2010 Jun;92(6):1343-52.
    Brace wear control of curve progression in adolescent idiopathic scoliosis.

    Katz DE, Herring JA, Browne RH, Kelly DM, Birch JG.

    Department of Orthopaedics, Texas Scottish Rite Hospital for Children, 2222 Welborn Street, Dallas, TX 75219. tony.herring@tsrh.org.
    Abstract

    BACKGROUND: The efficacy of brace treatment for patients with adolescent idiopathic scoliosis remains controversial, and effectiveness remains unproven. We accurately measured the number of hours of brace wear for patients with this condition to determine if increased wear correlated with lack of curve progression. METHODS: Of 126 patients with adolescent idiopathic scoliosis curves measuring between 25 degrees and 45 degrees , 100 completed a prospective study in which they were managed with a Boston brace fitted with a heat sensor that measured the exact number of hours of brace wear. Orthopaedic teams prescribed either sixteen or twenty-three hours of brace wear and were blinded to the wear data. At the completion of treatment, the number of hours of brace wear were compared with the frequency of curve progression of >/=6 degrees and with curve progression requiring surgery. RESULTS: The total number of hours of brace wear correlated with the lack of curve progression. This effect was most significant in patients who were at Risser stage 0 (p = 0.0003) or Risser stage 1 (p = 0.07) at the beginning of treatment and in patients with an open triradiate cartilage at the beginning of treatment. Logistic regression analyses showed a "dose-response" curve in which the greater number of hours of brace wear correlated with lack of curve progression. Brace wear to school and immediately afterward was most successful. Curves did not progress in 82% of patients who wore the brace more than twelve hours per day, compared with only 31% of those who wore the brace fewer than seven hours per day (p = 0.0005). The number of hours of brace wear also correlated inversely with the need for surgical treatment (p = 0.0005). The number of hours of wear were similar for the patients who were advised to wear the brace sixteen or twenty-three hours daily. CONCLUSIONS: The Boston brace is an effective means of controlling curve progression in patients with adolescent idiopathic scoliosis when worn for more than twelve hours per day. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

    PMID: 20516309 [PubMed - in process]

  2. #2
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    And, on the other side of the coin....

    http://www.ncbi.nlm.nih.gov/pubmed/20461027

    Spine (Phila Pa 1976). 2010 Jun 1;35(13):1285-93.
    Braces for idiopathic scoliosis in adolescents.

    Negrini S, Minozzi S, Bettany-Saltikov J, Zaina F, Chockalingam N, Grivas TB, Kotwicki T, Maruyama T, Romano M, Vasiliadis ES.

    ISICO (Italian Scientific Spine Institute), Milan, Italy. stefano.negrini@isico.it
    Abstract

    STUDY DESIGN: Cochrane systematic review. OBJECTIVE: To evaluate the efficacy of bracing in adolescent patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: AIS is a 3-dimensional deformity of the spine. Although AIS can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Braces are traditionally recommended to stop curvature progression in some countries and criticized in others. They generally need to be worn full time, with treatment extending over years. METHODS: The following databases (up to July 2008) were searched with no language limitations: the Cochrane Central Register of Controlled Trials, MEDLINE (from January 1966), EMBASE (from January 1980), and CINHAL (from January 1982), and reference lists of the articles. An extensive handsearch of the gray literature was also conducted. Randomized controlled trials (RCTs) and prospective cohort studies were searched for comparing braces with no treatment, other treatment, surgery, and different types of braces. Two review authors independently assessed trial quality and extracted data. RESULTS: We included 2 studies. There was very low quality evidence from 1 prospective cohort study with 286 girls that a brace curbed curve progression at the end of growth (success rate, 74% [95% confidence interval {CI}: 52%-84%]), better than observation (success rate, 34% [95% CI: 16%-49%]) and electrical stimulation (success rate, 33% [95% CI: 12%-60%]). There is low-quality evidence from 1 RCT with 43 girls that a rigid brace is more successful than an elastic one (SpineCor) at curbing curve progression when measured in Cobb degrees, but there were no significant differences between the 2 groups in the subjective perception of daily difficulties associated with wearing the brace. CONCLUSION: There is very low quality evidence in favor of using braces, making generalization very difficult. Further research could change the actual results and our confidence in them; in the meantime, patients' choices should be informed by multidisciplinary discussion. Future research should focus on short- and long-term patient-centered outcomes, in addition to measures such as Cobb angles. RCTs and prospective cohort studies should follow both the Scoliosis Research Society and Society on Scoliosis Orthopedic and Rehabilitation Treatment criteria for bracing studies.

    PMID: 20461027 [PubMed - in process]

  3. #3
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    And, the truth probably lies somewhere in the middle

    http://www.ncbi.nlm.nih.gov/pubmed/17728687

    Spine (Phila Pa 1976). 2007 Sep 1;32(19 Suppl):S91-S100.
    Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review.

    Dolan LA, Weinstein SL.

    Department of Orthopaedics and, Rehabilitation, University of Iowa Healthcare, Iowa City, IA, USA. lori-dolan@uiowa.edu
    Abstract

    STUDY DESIGN:: Systematic review of clinical studies. OBJECTIVES:: To develop a pooled estimate of the prevalence of surgery after observation and after brace treatment in patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA:: Critical analysis of the studies evaluating bracing in AIS yields limited evidence concerning the effect of TLSOs on curve progression, rate of surgery, and the burden of suffering associated with AIS. Many patients choose bracing without an evidence-based estimate of their risk of surgery relative to no treatment. Therefore, such an estimate is needed to promote informed decision-making. METHODS:: Multiple electronic databases were searched using the key words "adolescent idiopathic scoliosis," "observation," "orthotics," "surgery," and "bracing." The search was limited to the English language. Studies were included if observation or a TLSO was evaluated and if the sample closely matched the current indications for bracing (skeletal immaturity, age <15 years, Cobb angle between 20 degrees and 45 degrees ). One reviewer (L.A.D) selected the articles and abstracted the data, including research design, type of brace, minimum follow-up, and surgical rate. Additional data concerning inclusion criteria and risk factors for surgery included gender, Risser, age and Cobb angle at brace initiation, curve type, and dose (hours of recommended brace wear). RESULTS:: Eighteen studies were included (observation = 3, bracing = 15). All were Level III or IV clinical series. Despite some uniformity in surgical indications, the surgical rates were extremely variable, ranging from 1 surgery of 72 patients (1%) to 51 of 120 patients (43%) after bracing, and from 2 surgeries of 15 patients (13%) to 18 of 47 patients (28%) after observation. When pooled, the bracing surgical rate was 23% compared with 22% in the observation group. Pooled estimates for surgical rate by type of brace, curve type, Cobb angle, Risser sign, and dose were also calculated. 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.

    PMID: 17728687 [PubMed - indexed for MEDLINE]

  4. #4
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    Quote Originally Posted by LindaRacine View Post
    http://www.ncbi.nlm.nih.gov/pubmed/20516309

    J Bone Joint Surg Am. 2010 Jun;92(6):1343-52.
    Brace wear control of curve progression in adolescent idiopathic scoliosis.

    Katz DE, Herring JA, Browne RH, Kelly DM, Birch JG.

    Department of Orthopaedics, Texas Scottish Rite Hospital for Children, 2222 Welborn Street, Dallas, TX 75219. tony.herring@tsrh.org.
    Abstract

    BACKGROUND: The efficacy of brace treatment for patients with adolescent idiopathic scoliosis remains controversial, and effectiveness remains unproven. We accurately measured the number of hours of brace wear for patients with this condition to determine if increased wear correlated with lack of curve progression. METHODS: Of 126 patients with adolescent idiopathic scoliosis curves measuring between 25 degrees and 45 degrees , 100 completed a prospective study in which they were managed with a Boston brace fitted with a heat sensor that measured the exact number of hours of brace wear. Orthopaedic teams prescribed either sixteen or twenty-three hours of brace wear and were blinded to the wear data. At the completion of treatment, the number of hours of brace wear were compared with the frequency of curve progression of >/=6 degrees and with curve progression requiring surgery. RESULTS: The total number of hours of brace wear correlated with the lack of curve progression. This effect was most significant in patients who were at Risser stage 0 (p = 0.0003) or Risser stage 1 (p = 0.07) at the beginning of treatment and in patients with an open triradiate cartilage at the beginning of treatment. Logistic regression analyses showed a "dose-response" curve in which the greater number of hours of brace wear correlated with lack of curve progression. Brace wear to school and immediately afterward was most successful. Curves did not progress in 82% of patients who wore the brace more than twelve hours per day, compared with only 31% of those who wore the brace fewer than seven hours per day (p = 0.0005). The number of hours of brace wear also correlated inversely with the need for surgical treatment (p = 0.0005). The number of hours of wear were similar for the patients who were advised to wear the brace sixteen or twenty-three hours daily. CONCLUSIONS: The Boston brace is an effective means of controlling curve progression in patients with adolescent idiopathic scoliosis when worn for more than twelve hours per day. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

    PMID: 20516309 [PubMed - in process]
    This is an in-brace study unless by "completion of treatment" they mean several years out. We would have to get the paper but "completion of treatment" could mean shortly after the brace was removed for the last time as it essentially was in another paper posted to the forum a while ago that used similar wording IIRC.

    Short term results from brace studies even a few years out may not be meaningful as I am coming to realize. The mean is one thing... the variability is another. There are two crapshoots, not one as I suggest most are lead to believe.
    Last edited by Pooka1; 06-07-2010 at 06:36 PM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
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  5. #5
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    I'm going to try to get that paper but hopefully they will discuss the issue of delaying surgery vice avoiding it with brace wear. Thus unless this study has been run out several years, the results are something you can measure (avoiding surgery in the immediate post-brace period) but means little if surgery is only delayed for the same percentage of kids who wore the brace more.
    Last edited by Pooka1; 06-07-2010 at 07:23 AM.
    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."

  6. #6
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    Here's a long term study that I think would go far to answer the bracing efficacy question...

    All patients are in the 30* range or below at maturity.

    Compare the surgical rates in the out years for the following:

    1. people who never wore a brace
    2. people who wore a brace prior to maturity

    Is there a difference in surgical rates in the out years in people whose curves might have been artificially held with a brace versus those whose curves held on their own?

    There may be no difference which is consistent with the brace not affecting the long term. If the braced patients have lower surgical rates then we might surmise the brace somehow affects scoliosis neurology and biochemistry which seems hard to believe.
    Last edited by Pooka1; 06-10-2010 at 06:11 AM.
    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."

  7. #7
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    I don't think there is any way to accurately tell bracing efficacy unless they follow the people through their whole lives. I would be the the "watch and wait" category. My curves didn't start to progress until I was 39 years old. I will eventually need surgery. They really need to follow these people for their life spans. I know that is nearly impossible because the kids live longer than the researchers, but it just wouldn't be accurate to much degree if they didn't. So the whole truth will never be known. My opinion.

  8. #8
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    This is an interesting article about the criteria for surgical intervention that has followed some people up to 50 years. It doesn't have anything to do with bracing, but because of my previous comment I thought it was appropriate. Is it worth waiting until middle age or later years to fuse? If the bracing just puts off the inevitable, the consequenses could be worse due to the fact that people end up needing surgery when they are not young and healthy. I have seen many people end up having surgery on this forum that were braced as children. Here it is:

    http://www.scoliosisjournal.com/content/3/1/6

  9. #9
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    Quote Originally Posted by rohrer01 View Post
    Is it worth waiting until middle age or later years to fuse? If the bracing just puts off the inevitable, the consequenses could be worse due to the fact that people end up needing surgery when they are not young and healthy.
    I am SO glad I waited until 39 to have surgery: Technology came a long way in the years since I was diagnosed. Just my opinion, but without evidence of curve progression, surgery should always be the last option ... not a preemptive move.

    The exception to that, for me, is VBS - primarily due to the small window of opportunity.

    Pam
    Fusion is NOT the end of the world.
    AIDS Walk Houston 2008 5K @ 33 days post op!


    41, dx'd JIS & Boston braced @ 10
    Pre-op 53, Post-op < 20
    Fused 2/5/08, T4-L1 ... Darrell S. Hanson, Houston


    VIEW MY X-RAYS
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  10. #10
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    I agree as surgery being the last option when everything else has been tried. However, if bracing just puts off a progression that is going to happen anyway, we need to weigh the consequensed of having surgery in our middle or later years vs. "hoping" technology comes up with a better solution. You were fortunate in that something better was offered, but not everyone falls into that frame of time where something better may be offered.

  11. #11
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    Quote Originally Posted by rohrer01 View Post
    You were fortunate in that something better was offered, but not everyone falls into that frame of time where something better may be offered.
    rohrer,

    I think maybe I wasn't clear in my previous post ...

    I had full on fusion surgery 30 years after I was initially braced as a kid. My "better" option was simply improved surgical techniques and hardware ... but essentially the same surgery vs. something new.
    Fusion is NOT the end of the world.
    AIDS Walk Houston 2008 5K @ 33 days post op!


    41, dx'd JIS & Boston braced @ 10
    Pre-op 53, Post-op < 20
    Fused 2/5/08, T4-L1 ... Darrell S. Hanson, Houston


    VIEW MY X-RAYS
    EMAIL ME

  12. #12
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    I am about the same age as you. I was diagnosed at age 16 with a curve that could not be braced due to it's location. I had no choice but to be put into the watch and wait category. "IF" they would have done surgery when I went over the 40* mark (at around 30 yrs of age), I could have had only a 5 or 6 level fusion. Waiting for my curve to progress has caused more harm as I developed a second major curve due to the first one being present. I am now looking at a 12 to 14 level fusion. This is why I, personally, wished they would have done it sooner. I felt much healthier to undergo such a procedure 12 years ago than I do now as I have developed arthritis and heart problems. I can only imagine how it will be if I wait longer. I know everyone is different. That is why we need to have options about bracing and surgical intervention and we need to weigh them and consider very carefully what is right for ourselves. It would be really nice if they could accurately predict the outcome, but since we are all individuals we have to rely on data from studies of other people. It seems to me that bracing has become a vain attempt to put off the inevitable, and that's okay. If a person chooses to wait, there is nothing wrong with that. It's just that younger bodies heal faster and better.

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