Pittsburgh, June 15, 2007 -- Eighty percent of individuals will have at least one episode of low back pain in their lifetimes. Lower extremity radicular pain, or sciatica, lasting at least two weeks occurs in almost 2% of the adult population each year. Back problems are the fifth leading cause of medical visits in the United States and the leading cause of work-related disability. However, ninety percent of patients with back pain recover without any intervention within four weeks.

Lumbar discectomy surgery is the most common surgical procedure performed for back and leg symptoms in the United States, but the efficacy of the procedure relative to nonoperative care has remained unknown. The National Institutes of Health therefore initiated a trial in March 2000 called the Spine Patient Outcomes Research Trial (SPORT) at 13 centers throughout the United States in order to compare outcomes after two years of surgical versus nonoperative treatment for patients suffering from lumbar disc herniation.

Five hundred patients with pain caused by a herniated disc for at least six weeks were enrolled in this trial and randomized to either surgery or nonsurgical therapy. An additional 743 patients, who declined to be randomized for the trial, were enrolled in an observational cohort investigation and followed for two years as well. The results of both of these studies were recently published in the Journal of the American Medical Association (JAMA 296(20):2441, 2007).

In the randomized clinical trial, the results favored the group which underwent surgery at all follow-up time points. The study concluded, “Between-group differences in outcomes were consistently in favor of surgery for all outcomes and at all time periods.” In addition, the rate of complications in the surgical group was exceedingly low. Significant controversy has surrounded this study because of the “intention-to-treat” analysis that decreased the true positive effect that surgery had on outcome. Furthermore, there was a significant degree of crossover of patients in both arms with 40% of patients assigned to surgery not getting surgery and 45% of patients assigned to nonsurgery ultimately undergoing discectomy. In the “as-treated” statistical analysis, the results even more heavily favored surgery.

In the observational cohort portion of the study, patients who declined to be randomized were followed and allowed to choose between surgery and non-surgical therapies. The patients in this group overall were more likely to have more significant pain or a neurological deficit than the patients in the randomized clinical trial group. Interestingly, 22% of patients who entered into this group because they did not want to be randomized to having surgery because they wanted to try nonsurgical therapies first ultimately underwent a discectomy during the two year follow-up.

In this study, there was a statistically significant difference in all primary and secondary outcomes, favoring surgery. “In this nonrandomized evaluation of patients with persistent sciatica from lumbar disk herniation who had operative or usual care, both treatment groups improved considerably over two years....patients who underwent discectomy had significantly better self-reported outcomes than those who had usual care.”

The SPORT Trial was the largest, best designed, most costly, and most important clinical trial ever performed to study a spinal disorder and its surgical management. This information will be of great benefit to our patients who suffer from sciatica. We can now inform them with the highest level of scientific evidence possible that lumbar discectomy surgery is safe, it is not necessary with patients with mild symptoms, and it is highly effective for patients with severe symptoms. In the near future, we will have available to us the results of the trial that evaluated the surgical treatment of lumbar stenosis and degenerative spondylolisthesis.