A multi-center study, led by the University of Iowa, was conducted to determine if wearing a back brace could prevent the need for spinal correction surgery in children and adolescents suffering from idiopathic scoliosis (AIS). The study was cut short when early results overwhelmingly favored the notion.

Stuart Weinstein, MD, Ignacio V. Ponseti Chair and Professor of Orthopaedic Surgery and Professor of Pediatrics at University of Iowa Children’s Hospital, and Lori Dolan, PhD, a research scientist in The Department of Orthopaedics and Rehabilitation at the UI Carver College of Medicine, led a research team in comparing the risk of curve progression in patients with AIS who wore a brace to patients who did not.  Patients who were at risk for continued worsening of their spinal curves based on age, skeletal immaturity and curve severity were recruited for the study.

Weinstein has worked with scoliosis patients for almost 40 years, and although bracing has been used as a treatment for curvature of the spine since 1948, he says its ability to prevent surgery has always been questioned.

“The efficacy of bracing was never really proven,” he says. “I wasn’t sure if braces really worked or not, and I’ve treated thousands of patients.”

Nearly 400 subjects at 25 institutions in the U.S. and Canada were enrolled in the study from March 2007 to February 2011. The study originally began as a randomized clinical trial, but a preference cohort was later added in which patients and their families could choose their own treatment. Around 40 percent of the participants were randomly assigned braces or to be closely observed without them. The rest of the participants made their own choice between bracing or observation.

Participants under observation received no specific treatment, but those in braces were instructed to wear the brace for 18 hours each day. Treatment was considered unsuccessful if a spinal curve progressed to 50 degrees or more, the point at which surgery is usually recommended. Treatment was considered successful when the child reached the age of skeletal maturity without such a degree of curve progression.

The trial was stopped in January 2013 after 72 percent in the bracing group and 48 percent in the observation group achieved success. Wearing a brace more than 13 hours per day was found to be associated with a success rate of 90 to 93 percent in participants.

“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.”

The study is published in the New England Journal of Medicine.