June 26, 2008
Contact: Lauren Cruse (505) 272-3690
The Pediatric Orthopaedic Division of the University of New Mexico Carrie Tingley Hospital is participating in a new, multi-center study to find 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 U.S. The Canadian Institute of Health Research will fund two participating Canadian centers and five Shrine Hospital centers will be funded by the Shrine system.
Patrick Bosch, M.D., assistant professor of orthopaedic surgery in the Department of Orthopaedics and Rehabilitation at UNM, is the study’s principal investigator for New Mexico.
Scoliosis causes curvature of the spine and affects about three 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 the child’s torso, are prescribed to limit further curve progression in certain children with curves between 24 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, con-trolled study to say whether they work or not.
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 receive a rigid brace that they will 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 study may have major implications on how we treat scoliosis in the future," said Bosch. "If bracing is proved effective, we can emphasize the likely success with brace use to skeptical teenagers. If it does not work, we can stop spending the resources and wasting these kids efforts on an ineffective treatment."
In the U.S., 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, 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 will also 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 will also measure the effect of the "dose" of bracing to determine if there is a relationship between the amount of time a patient wears a brace and the amount of curve progression. The researchers will also try to determine other risk factors that might contribute to curve progression and provide clues as to why scoliosis becomes worse in some children, but not in others.
"The opportunity to participate in such an important study is very exciting," said Bosch. "Enrolling New Mexicans in national studies improves their applicability to our patients and improves the quality of the studies as well."
Approximately 450 patients will be recruited to the trial. At UNM, approximately 30 patients will participate. 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 Bosch, the Carrie Tingley Hospital research team includes, Brittany Eastlund, RN, study coordinator, Elizabeth Alderete, RN, study co-coordinator, Susana Sweetman, certified orthotist, and Tony Girard, certified orthotist.