In the first large-scale test of whether wearing a brace helps to prevent an already-curved childhood spine from twisting further, bracing was nearly twice as effective as a watch-and-wait approach at preventing kids from needing corrective surgery.
But the study also found that too many children with scoliosis are being given a brace when they don't need one. Data from the new research may help doctors identify which children need to wear the brace and when it is better to just keep tabs on the child.
The study "really answers the question that parents raise - 'If you're going to prescribe a brace for my child, does it work?'" said Dr. Stuart Weinstein, lead author of the study, which was published online by the New England Journal Medicine and reported Thursday at the Scoliosis Research Society's annual meeting in Lyon, France. "The answer is that braces have a very high success rate," he said.
"We also found that the longer the child wore the brace, the more likely you were to achieve success," he said. "Children who wore it more than 13 hours a day had a 90 percent to 93 percent chance of success for avoiding having the curve progressing to a surgical threshold."
The results were so pronounced, the test of 242 youngsters in the U.S. and Canada was halted early.
"It certainly reinforces our present approach to bracing in these at-risk adolescents," Dr. Allan Beebe, an orthopedic specialist at Nationwide Children's Hospital in Columbus, Ohio, who was not connected with the research, said in an email. "This study appears to be better science" than the previous research on bracing.
About 2 to 3 percent of children have some degree of spine curvature, but only 0.3 to 0.5 percent have progressively worsening curves that make them candidates for treatment aimed at avoiding the need for surgery.
Once the spinal curve gets beyond 50 degrees, there's a high risk it will continue worsening into adulthood unless corrected surgically. So treating the problem early is preferable, and less expensive.
Weinstein and his colleagues point out in their report that there were more than 3,600 spinal surgeries to correct adolescent scoliosis in the U.S. in 2009. At a total cost of $514 million, the procedure "ranked second only to appendicitis" for children 10 to 17 years old.
"Bracing has been the standard method of trying to protect patients from needing surgery ever since a brace was developed in the 1940s, said Weinstein, of the University of Iowa. "But it was never really proven if it was effective. There was never a randomized trial where some children were braced and some weren't. The data were inconsistent."
The original plan for the study was to randomly assign some children to a brace and to simply watch others to see whether the curve of the spine became too severe. In either case, progression of the curve to 50 degrees or more indicated that the assigned treatment had not worked.
But many parents had strong feelings about how they wanted their child treated and declined to allow a treatment to be randomly selected for them. So the research team let those parents choose a treatment; 70 percent chose a brace.
"The interesting fact was that when you looked at both the randomized children and those who chose their preference, bracing produced an overwhelming 72 percent success rate when it came to preventing the need for surgery," Weinstein said. The success rate in the observation group was 48 percent.
The success rate among children randomly assigned to bracing was even higher, at 78 percent.
A temperature sensor logged the amount of time the child wore the brace.
"The study provided pretty overwhelming evidence that braces are effective," Weinstein said.
But it was also clear from the results that many bracing treatments are unnecessary.
Nearly half of the participants in the watch-and-wait group during the trial did not have curve progression to the point of needing surgery. The same was true for 41 percent of kids in the bracing group who actually spent very little time wearing their braces.
"We're unnecessarily bracing two patients to get the one patient who actually needs it. We are still overtreating patients," Weinstein said.
A further analysis of the data might prevent some of that unnecessary treatment, he said.
"We will probably, in the next year or so, be analyzing all the factors so we can hone down better who the ideal candidate for bracing is," Weinstein said.