A new, multi-center study led by University of Iowa orthopaedic researcher Stuart Weinstein, MD, aims to find out if bracing is effective in treating adolescent scoliosis, which causes curvature of the spine and affects about three percent of children ages 10 to 16 years old.
"The current standard treatment for scoliosis is use of a plastic-type brace for curves between 25 and 40 degrees in a patient who is skeletally immature," Weinstein says. "Bracing has been the standard of care since 1948, yet no one has ever really determined whether it is effective or not. In other words, there's never been a randomized, prospective trial on bracing versus no bracing. So our hope is to determine is bracing really an effective treatment for scoliosis."
Weinstein says eligible study participants will be children between 10 and 16 years old who have a curvature of the spine between 25 and 40 degrees and who are skeletally immature. "The first aspect of the study is agreeing to be randomized-in other words, to have us flip a coin, so to speak, to determine are they in the bracing treatment group versus the observation group," Weinstein says. "Otherwise, the children will be followed just as we normally follow every patient with scoliosis. They will be asked to come back for regular visits on a six-month basis with follow-up x-rays until maturity, at which time we'll be able to tell of braces really are effective or they're not effective."
Weinstein says that aside from the treatment of the spine, "We also want to find out are there any psychological effects of wearing a brace. There have been some studies to imply that there are. We want to look at the quality of life, how does it affect self-image? We also want to know about a dosing of brace ... in other words, if you wear the brace for a longer period of time, does that make a difference in outcome or success?"
Researchers will also explore what other risk factors might contribute to curve progression. This might provide them clues as to why scoliosis gets worse in some children and not in others, Weinstein says.
"The study-a nationwide trial involving thirteen U.S. centers, two Canadian centers, and five Shrine hospitals-will probably take five years to determine the outcome of whether bracing is effective or not," Weinstein says. "We will follow everyone who enrolls in the study until they reach skeletal maturity."
Weinstein believes the study will have a profound impact on public health policy. "For example, if the study finds that bracing is of no benefit at all, the amount of resources that are currently devoted to school screening programs might be better put to use in other public health efforts," he says. "If, however, the study does show that bracing is effective and we can stop the progression of scoliosis and prevent surgery, then it has the tremendous dollar and financial and public health policy implications of supporting school screening and making it a nationwide effort to prevent the need for surgery." |
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