Seattle's Children's Hospital Contributes to International Research Examining Bracing Treatment Protocols for Adolescent Scoliosis
May 07, 2007
A multi-center study by orthopedic researchers hopes to discover if torso bracing is actually effective in treating adolescent idiopathic scoliosis (AIS).
A multi-center study by orthopedic researchers hopes to discover if torso bracing is actually effective in treating adolescent idiopathic scoliosis (AIS). Children’s has received NIH funding to participate along with 19 other sites, including hospitals in the United States and Canada. Children’s will provide part of the data looking at an aggregate of 450 subjects aged 11-14 from all sites. Approximate funding total is $6 million for the entire project over five years. This study marks the first NIH randomized, controlled trial grant for pediatric orthopedics.
Scoliosis causes spine curvature, affecting 3 percent of children 10 to 16 years old. Although many cases do not require treatment, scoliosis braces which strap around a child’s torso are often prescribed to decrease spine curves in certain children. Typically the braces are made from rigid plastic and resemble a laced corset designed to keep the spine in a specific position, worn under clothing. Patients wear braces for an average of three years until skeletal maturity is reached. Unfortunately, bracing can cause social stigma and awkwardness for patients, many of whom are adolescent girls at a key time during puberty.
Bracing has been the standard non-surgical treatment since developed in the 1940’s and gaining popularity in the 1960’s, but until now there has not been a conclusive, controlled study looking at efficacy. Currently, patients undergo this treatment without knowing the probability of success or failure.
It is hoped this study will clarify the efficacy of bracing as well as secondarily shed light on related issues such as correct brace “dosing,” psychosocial aspects of bracing, quality of life, self-image and functioning of braced patients, brace wear and compliance, and even public policies affecting scoliosis screening. Better understanding of risk factors that may contribute to spine curve progression and why scoliosis worsens in some children but not others may be an additional study benefit.
This is the first 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 from one group will receive a rigid brace to wear for 18 hours daily. The second group will be treated simply by watchful waiting. Both groups will be closely followed to track scoliosis progression.
“This trial could significantly change how we approach AIS patients. Until now we’ve used bracing as a default treatment without fully understanding what it means to our young patients, and how it actually compares with a more conservative watch-and-wait approach,” said Kit M. Song, MD, Assistant Director, Department of Orthopedics at Children’s. “Impacts to care protocol as well as policies of scoliosis screening might forever change depending on study outcomes.”
Currently scoliosis screening is mandatory in the state of Washington for 5th and 7th graders, and 21 other states are similarly required to screen for the condition. National health care costs resulting from screening programs reaches approximately $41 million. A recent report by the U.S. Preventative Task Force (USPTF) concluded there has been inadequate evidence that braces work. This research may therefore have direct bearing on scoliosis testing requirements, affecting national policy and funding allocation for screening. If bracing is confirmed to prevent curve progression, the improvement of screening programs could potentially decrease the number of spine-straightening surgeries that occur, reducing health care costs. Conversely, if bracing show little or no efficacy, funds for screening programs may be better spent on other public health programs.
Those seeking information about participating in the study can contact the research coordinator for this project at Children’s Hospital: (206) 987-3077.
About Seattle Children’s Research Institute
Located in downtown Seattle’s biotech corridor, Seattle Children’s Research Institute is pushing the boundaries of medical research to find cures for pediatric diseases and improve outcomes for children all over the world. Internationally recognized investigators and staff at the research institute are advancing new discoveries in cancer, genetics, immunology, pathology, infectious disease, injury prevention and bioethics, among others. As part of Seattle Children’s Hospital, the research institute brings together leading minds in pediatric research to provide patients with the best care possible. Seattle Children’s serves as the primary teaching, clinical and research site for the Department of Pediatrics at the University of Washington School of Medicine, which consistently ranks as one of the best pediatric departments in the country. For more information, visit http://www.seattlechildrens.org/research.