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 children and teens who suffer from a spine curvature called adolescent idiopathic scoliosis (AIS), which affects up to 3% of children between ages 10 and 16. The trial revealed, overwhelmingly, that such a brace stops the progression of curves before they 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.
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.