When the results of a clinical trial are remarkably good, or bad, we end the trial early to translate the findings into action. Today I’m happy to share exciting news about a trial that was stopped early because of a good outcome. This was an NIH-funded clinical trial that investigated the benefits of wearing a back brace for tweens and teens who suffer from a spine curvature called adolescent idiopathic scoliosis (AIS), which affects up to 3% of children and teens between ages 10 and 16. The trial revealed, overwhelmingly, that such a brace stops the progression of curves before they require surgery .
It’s not clear what causes scoliosis, but kids, particularly girls, are at risk during the time they are growing rapidly. In the majority of cases the curve, which can be C or S-shaped, is mild and doesn’t progress. But if the curvature gets more pronounced (greater than 50 degrees), it can distort posture and gait, cause pain, and ultimately require surgery.
A brace has been the standard treatment for AIS. But whether the brace stops the curve from worsening hadn’t been rigorously tested—which is why the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) was launched in 2007. The study leaders enrolled 383 subjects at 25 institutions. Participants either received no treatment (this was the observation group) or a rigid brace that had to be worn for at least 18 hours each day.
The brace contained a sensor that indicated when the participant was wearing it. And although many didn’t keep the brace on for the full 18 hours, it was clear that the longer it was worn, the better the results. The treatment was a success if the patient’s spine matured before the curve progressed to 50 degrees. For 72% of patients wearing the brace the treatment was successful, compared with only 48% who didn’t receive treatment.
These results, published in this week’s issue of the New England Journal of Medicine, don’t mean that all children with curved spines require a brace. Age, the degree of curvature, and whether the spine is still growing are all important considerations when choosing a treatment option for your child. But the findings do prove that bracing is an effective treatment for those children who are at high risk for severe spinal curves.
 Effects of Bracing in Adolescents with Idiopathic Scoliosis. Weinstein SL, Dolan LA, Wright JG, Dobbs, MB. N Engl J Med. 2013 Sep 19 (Epub ahead of print).
Scoliosis in children and adolescents (NIH/NIAMS)
Bracing in Adolescent Idiopathic Scoliosis (clinical trial website—audio starts automatically in some browsers)
NIH support: National Institute of Arthritis and Musculoskeletal and Skin Diseases