University of Iowa News
July 19, 2006
UI To Lead Multi-Center Clinical Trial To Evaluate Bracing For Scoliosis
A new, multi-center study led by University of Iowa orthopaedics researchers aims to find out if bracing is effective in treating adolescent idiopathic scoliosis.
A five-year, $4.9 million grant from the National Institutes of Health will fund the study at 13 medical centers in the United States. The Canadian Institute of Health Research will fund two participating Canadian centers, and five Shrine Hospital centers will be funded by the Shrine system.
Stuart Weinstein, M.D., the Ignacio V. Ponseti Chair and Professor of Orthopaedic Surgery in the Department of Orthopaedics and Rehabilitation at the UI Roy J. and Lucille A. Carver College of Medicine, is the study's principal investigator overseeing all 20 centers.
Scoliosis causes curvature of the spine and affects about 3 percent of children 10 to 16 years old. Although the majority of these children do not require treatment, braces -- a corset-like device that straps around a child's torso -- are prescribed to limit further curve progression in certain children with curves between 25 and 40 degrees. Patients wear the brace for an average of three years until they reach skeletal maturity.
"Braces have been the standard, non-operative treatment for scoliosis since they were developed in the 1940s, but there has never been a prospective, randomized, controlled study to say whether they work or not," Weinstein said.
The new study is the first head-to-head comparison between bracing and watchful waiting without treatment for scoliosis. Participants with similar degrees of scoliosis will be randomly assigned to one of two groups. Participants in one group will get a rigid brace that they will be told to wear for 18 hours each day. Participants in the second group will be treated by watchful waiting. Both groups will be closely followed over the study period to track how much the scoliosis progresses.
"The results of this study may have major public health implications," Weinstein said. "If bracing is shown to be effective, then we can be very forceful in our recommendations that children be compliant with their bracing treatment. If it doesn't work, then we are spending a lot of money unnecessarily on school screening and on bracing and doctor visits."
In the United States, scoliosis screening is mandated by state law in 22 states, and many other voluntary screening programs exist. The total annual charges resulting from these programs is approximately $56 million. However, a recent report by the U.S. Preventative Task Force (USPTF), based on a review of the available literature, concluded that there was inadequate evidence that braces work.
If the study finds no benefit to bracing, the resources currently devoted to school screening for scoliosis might be better used for other public health efforts. However, if the study shows that bracing prevents curve progression, then improving screening programs to identify children who would benefit from bracing could produce long-term savings due to a decrease in the number of spine-straightening surgeries performed for spinal curves that progress beyond 50 degrees.
The study also will evaluate several other aspects of the participants' health and functioning. Quality-of-life indicators, including self-image over time, will be measured to compare how bracing affects these factors. For many children, the brace-wearing period often coincides with the junior high and high school years, and some studies have suggested that bracing may have some adverse psychological effects.
The researchers also will measure the effect of the "dose" of bracing to determine if there a relationship between the amount of time a patient wears a brace and the amount of curve progression. Finally, the researchers will try to determine other risk factors that might contribute to curve progression and provide clues as to why scoliosis gets worse in some children but not in others.
"We are really excited to have this opportunity, and it is a natural progression of the type of research we have been doing at the UI for many years on spinal deformities," Weinstein said. "Previously, in a 50-year study, we traced the natural history of scoliosis without treatment. The next question we need to answer is whether the treatments applied to children are effective."
Approximately 450 patients will be recruited to the trial. These participants will have received a diagnosis of scoliosis with curvature between 25 and 40 degrees, and they will be skeletally immature. If a study participant's curve reaches 50 degrees or more during the study, spine-straightening surgery, which is the standard of care for large curves, will be recommended.
In addition to Weinstein the UI research team includes, Lori Dolan, Ph.D., the clinical trial manager and director of the clinical coordinating center; Jose Morcuende, M.D., Ph.D., assistant professor of orthopaedics and rehabilitation, who is director of the radiographic reading center; and William Clarke Ph.D., professor of biostatistics in the UI College of Public Health, who is director of the data and statistical management center.
University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.
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