Surgical versus nonsurgical treatment of three back disorders will be studied in 1,450 patients at 11 medical centers with funds awarded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH). Researchers at these centers will compare the two treatment approaches in patients who have a herniated (bulging) lumbar disc, spinal stenosis (narrowing of the canal through which the spinal cord passes) or degenerative spondylolisthesis, where a vertebra in the spine slips forward out of place. This project is expected to have a major impact on clinical practice and on the cost of medical services for persons with one of the three back disorders.
The 5-year study, which will cost more than $13.5 million, is being performed under the direction of James N. Weinstein, D.O., M.S., professor in the Department of Community and Family Medicine, Center for the Evaluative Clinical Sciences, and professor of surgery at Dartmouth Medical School. Participating centers include: Case Western Reserve University (Cleveland, Ohio), Dartmouth Medical School (Hanover, N.H.), Emory Spine Center (Decatur, Ga.), the Hospital for Special Surgery (New York, N.Y.), Rothman Institute (Philadelphia, Pa.), Nebraska Spine Surgeons, PC (Omaha, Neb.), Rush-Presbyterian-St. Luke Medical Center (Chicago, Ill.), University of California (San Francisco, Calif.), The Hospital for Joint Diseases (New York, N.Y.), Washington University (St. Louis, Mo.) and William Beaumont Hospital (Royal Oak, Mich.).
Patients enrolled in the study will be randomly assigned to either surgical or nonsurgical treatment. In the nonsurgical group, treatments will be prescribed according to the diagnosis and duration of the condition. Among the nonsurgical treatments included in the study are: 1-3 days of bed rest, physical therapy, home exercise, epidural injections, and oral nonsteroidal anti-inflammatory drugs and other non-narcotic medications. Other nonsurgical treatments may be added by treating physicians as they and the patient deem appropriate. Researchers will collect and evaluate information from participants at 3, 6, 12, and 24 months regarding health-related quality of life, spine-related disability, and the use of resources for help. An additional 1,800 people with back pain will be observed to assess health and resource outcomes.
Pain involving the disorders of the lumbar spine is not only one of the most prevalent health problems for which people seek medical help, it is also one of the most costly in terms of medical treatment and disability involving days lost from work. Estimates of cost of medical care for those disabled by severe back pain range from $30 to $70 billion annually. Data from the preference observation group will be integrated with that from the randomized group to estimate cost-effectiveness of treatment. Dr. Stephen I. Katz, director of the NIAMS, says, "Based on this trial, we shall, for the first time, have scientific evidence regarding the relative effectiveness of surgical versus nonsurgical treatment of these commonly diagnosed lumbar spine conditions."
NIAMS funding for this study is supported by contributions from the NIH Office of Research on Women's Health and the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention.
General information about this study may be obtained by calling 1-888-794-2225. Media inquiries should be directed to Judi Forman, Project Coordinator, at (603) 650-2591.
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on the progress of research in these diseases.