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Previous Volume 358:794-810 February 21, 2008 Number 8 Next

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ABSTRACT

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. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov] .)

Source Information

From the Departments of Orthopedics (J.N.W., E.B., B.H.), Community and Family Medicine (T.D.T., J.D.L., A.N.A.T.), and Medicine (J.D.L., A.N.A.T.), Dartmouth Medical School, Hanover, NH, and Dartmouth–Hitchcock Medical Center, Lebanon, NH; William H. Beaumont Hospital, Royal Oak, MI (H.H.); Hospital for Special Surgery, New York (F.C.); Rothman Institute at Thomas Jefferson University, Philadelphia (T.A., A.H.); Emory Spine Center, Emory University, Atlanta (S.D.B.); Kaiser Permanente, San Francisco (H.G.); University of California at San Francisco, San Francisco (S.B.); and Rush–Presbyterian–St. Luke's Medical Center, Chicago (H.A.).

Address reprint requests to Dr. Weinstein at the Dartmouth Institute for Health Policy and Clinical Practice, Department of Orthopedics, Dartmouth Medical School, 1 Medical Center Dr., Lebanon, NH 03756, or at sport{at}dartmouth.edu.

Full Text of this Article

This article has been cited by other articles:

• Katz, J. N., Harris, M. B. (2008). Lumbar Spinal Stenosis. NEJM 358: 818-825 [Full Text]  
• (2008). Spinal Stenosis: Surgical vs. Nonsurgical Therapy. JWatch General 2008: 1-1 [Full Text]