I had the opportunity to hear Dr. Stuart Weinstein present the results of the BRAIST Randomized Control Trial for scoliosis bracing here at the Scoliosis Research Society (SRS) conference in Lyon France. Also today, the study is published in the New England Journal of Medicine (NEJM) and you can read the whole article online by clicking here: http://www.nejm.org/doi/full/10.1056/NEJMoa1307337?query=featured_home#t=article.
Dr. Weinstein was able to show that bracing was able to allow 75% of the children/adolescents who were braced were able to keep a curve below 50 degrees, with 50 degrees at time of skeletal maturity being considered a “failure” and all others considered a “success.”
After the session was over, I got a chance to go up and speak to Dr. Weinstein, and to Dr. Lori Dolan, his co-author for U. Iowa to discuss the paper in greater depth. Both were very gracious with their time, and I got a chance to talk to Lori at greater length. Several key points from our dialogue emerged:
1) Current indications for scoliosis bracing is far too broad and needs to be narrowed. We are bracing too many children and adolescents who are not benefiting from treatment.
2) Scoliosis Bracing does benefit a subgroup of patients, but the children/adolescents must be willing to wear the brace for 13-18 hours per day to have a reasonable chance to see any benefit.
3) Lori agreed that we can’t fully declare “success” with no surgery or curve less than 50 degrees at skeletal maturity, since some of those patients will continue to progress and/or have pain in adulthood and may eventually need surgery.
4) The emotional/family effect of wearing a brace during adolescent growth period should be considered when making the decision and personalized for each situation.
I also had some time this afternoon to see a couple of good science blogs talk about the article as well:
http://www.science20.com/news_articles/back_braces_work_adolescents_idiopathic_scoliosis-120784.
Here’s an extended quote from the ScientificBlogging Site that gives a nice summary of the paper and some quotes from Dr. Weinstein: For the study, investigators enrolled 383 subjects at 25 institutions in the United States and Canada between March 2007 and Feb 2011. Although the study began as a completely randomized clinical trial, the team eventually added a “preference cohort,” where patients and families could choose their own treatment. About 40 percent of study participants were randomly assigned to bracing or to close observation without bracing. The remaining participants made their own choice regarding bracing or observation.
Patients in the observation arm received no specific treatment, while those in the bracing arm were instructed to wear a brace for 18 hours per day. Treatment was considered to be unsuccessful when a curve progressed to 50 degrees or greater – a point at which surgery is typically recommended. Treatment was considered a success when the child reached the age of skeletal maturity without this degree of curve progression.
In January 2013, the trial was stopped early after finding that bracing significantly reduced the risk of curve progression and the need for surgery, and that more hours of brace wear was associated with higher success rates. Among both the randomized and preference cohorts, 72 percent in the bracing group, and 48 percent in the observation group achieved success. In addition, the results suggest that the more a patient wore the brace, the better the results; wearing a brace more than 13 hours per day was associated with success rates of 90 to 93 percent.
“This study definitely shows braces work and are effective in preventing the need for surgery,” Weinstein says. “Children who are at risk should be treated with a brace, and they should wear it at least 13 hours a day for it to be effective.”
According to the researchers, the findings are clinically relevant to patients for whom bracing would typically have been recommended. But until now, that recommendation had not been based on solid data. “This study presents important evidence addressing the fundamental question facing families and clinicians dealing with the diagnosis of AIS – does bracing prevent the need for surgery? The answer is clearly ‘yes’,” Weinstein says.
The investigators also suggest that current bracing indications may be too broad, since 48 percent of patients in the observation group and 41 percent of patients in the bracing group who wore the brace infrequently also achieved success. “Further analysis will help us identify those AIS patients for whom bracing may be the most beneficial,” Weinstein concludes.
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I liked Dr. Weinstein’s comments in the blog above, but would probably be cautious about concluding that bracing prevents the need for surgery altogether, since the endpoint for their current study is only until skeletal maturity — the game isn’t over when you are done growing. In our natural history study that we are preparing for publication now, as many as 38-40% of patients with scoliosis as a teen continued to progress during adulthood. Lori did say that they are planning to do a 2 year follow-up on their cohort to see if there is any further progression. We both agreed that even long-term follow-up would be helpful — even lifetime!! Certainly my hundreds and hundreds of adults over the years with progressive painful scoliosis would encourage us to consider such a long-term, full life approach.
In any case, it is a wonderful study and may encourage some of our guests to consider bracing, but it is a decision that requires dialogue with all parties — especially the young lady or gentleman who needs to commit to wear the brace for at least 13 hours a day for possibly several years.
Getting new guidelines for scoliosis bracing will also be important to look for in the future motivated by this study.
Dr. Lloyd Hey
Hey Clinic for Scoliosis and Spine Surgery
http://www.heyclinic.com
