SPORT: Significantly better outcomes from surgical vs. nonsurgical spinal stenosis treatment
The as-treated analysis showed a significant advantage in all primary outcomes for patients treated with surgery.
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Patients who undergo surgery for spinal stenosis experience significantly better improvements in pain and function compared to patients treated nonsurgically, according to new results from the Spine Patient Outcomes Research Trial.
James N. Weinstein, DO, MS, and colleagues at several U.S. centers, evaluated outcomes for 654 spinal stenosis patients enrolled in either a randomized cohort (289 patients) or an observational cohort (365 patients). They published their results in The New England Journal of Medicine.
Among patients in the randomized cohort, investigators randomly assigned 138 patients to undergo standard posterior decompressive laminectomy and 151 to receive nonsurgical interventions.
"The nonsurgical protocol was 'usual care,' which was recommended to include at least active physical therapy, education or counseling with home exercise instruction, and the administration of [NSAIDs], if tolerated," the authors reported.
Among patients in the observational cohort, 219 patients initially chose surgery and 146 patients initially chose nonsurgical care, according to the study.
At 2 years follow-up for the randomized cohort, investigators found that 67% of patients randomly assigned to surgery had undergone surgery, while 43% of patients randomly assigned to nonsurgical care also had undergone surgery.
For the observational cohort, 96% of patients who initially elected to undergo surgery had received surgery at 2 years follow-up. Also at 2 years, 22% of patients who had initially elected for nonsurgical treatments had received surgery, according to the study.
"In the two cohorts combined, 400 patients received surgery at some point during the first 2 years, and 254 received nonsurgical treatment," the authors wrote.
"Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 (Short Form-36) scale for bodily pain, with a mean difference in change from baseline of 7.8," they wrote.
However, investigators found no significant differences in physical function scores or Oswestry Disability Index scores.
"The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years," the authors noted.
"In patients with imaging-confirmed spinal stenosis without spondylolisthesis and leg symptoms persisting for at least 12 weeks, surgery was superior to nonsurgical treatment in relieving symptoms and improving function," they wrote.
However, "it is notable that the condition of patients in the nonsurgical group improved only moderately during the 2-year period," they added.
For more information:
- Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical versus nonsurgical therapy for spinal stenosis. N Engl J Med. 2008;358:794-810.