Background Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials. Methods Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years. Results A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. 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 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. 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. Conclusions In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically.

Study Design Randomized trial and concurrent observational cohort study Objective To compare 4 year outcomes of surgery to non-operative care for spinal stenosis. Summary of Background Data Surgery for spinal stenosis has been shown to be more effective compared to non-operative treatment over two years, but longer-term data have not been analyzed. Methods Surgical candidates from 13 centers in 11 U.S. states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort (RC) or observational cohort (OC). Treatment was standard decompressive laminectomy or standard non-operative care. Primary outcomes were SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability index (ODI) assessed at 6 weeks, 3 months, 6 months and yearly up to 4 years. Results 289 patients enrolled in the RC and 365 patients enrolled in the OC. An as-treated analysis combining the RC and OC and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years, with treatment effects (defined as mean change in surgery group minus mean change in non-op group) for BP 12.6 (95% CI, 8.5 to 16.7); PF 8.6 (95% CI, 4.6 to 12.6); and ODI −9.4 (95% CI, −12.6, to −6.2). Early advantages for surgical treatment for secondary measures such as bothersomeness, satisfaction with symptoms and self-rated progress also were maintained. Conclusions Patients with symptomatic spinal stenosis treated surgically compared to those treated non-operatively maintain substantially greater improvement in pain and function through four years.

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In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.).