The study initially intended to randomize patients into either a surgical or nonsurgical group and then observe and compare the results of the two groups. Unfortunately, a comparison of the two groups wasn't as easy as hoped. The researchers found that 40 percent of patients crossed over from the group into which they were randomized. That is, members of the nonoperative group chose to have surgery and members of the surgical group decided to forgo surgery for nonsurgical treatments. For that reason, the researchers compared groups based on the treatment they actually received instead of the treatment group to which they were assigned. Because the scientists were also studying similar patients who wanted to select which treatment they would receive (instead of being randomly assigned to a surgical or nonsurgical option), they were able to pool results from both studies, essentially creating a more powerful osbservational study at the expense of information gained from the statistically rigorous study design originally planned.

Patient crossover was also an issue in the first arm of the SPORT trial, which showed that patients who underwent surgery for another common back problem -- herniated discs -- experienced slightly more improvement than those who opted for nonsurgical treatments. Results of that trial were published in the Journal of the American Medical Association last November.


Results from the third major SPORT study, on the effectiveness of surgery vs. nonsurgical options for spinal stenosis without spondylolisthesis, are expected to be released later this year.

NIAMS Director Stephen I. Katz, MD, PhD, applauds the SPORT trial, saying its findings are beneficial for people with these common back problems. "While it is generally not a good idea to rush into back surgery, the SPORT trial shows there are conditions for which surgery clearly is the most effective treatment choice. These findings will help doctors better counsel their patients about treatment options."

Additional support was provided for this research by the NIH Office of Research on Women's Health and the National Institute of Occupational Safety and Health (NIOSH).

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services' National Institutes of Health, 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 research progress in these diseases. For more information about NIAMS, call the information clearinghouse at (301) 495-4484 or (877) 22-NIAMS (free call) or visit the NIAMS Web site at http://www.niams.nih.gov.

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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