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The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial

James N. Weinstein, DO, MSc; Tor D. Tosteson, ScD; Jon D. Lurie, MD, MS; Anna N. A. Tosteson, ScD; Brett Hanscom, MS; Jonathan S. Skinner, PhD; William A. Abdu, MD, MS; Alan S. Hilibrand, MD; Scott D. Boden, MD; Richard A. Deyo, MD, MPH

JAMA. 2006;296:2441-2450.

Context  Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.

Objective  To assess the efficacy of surgery for lumbar intervertebral disk herniation.

Design, Setting, and Patients  The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.

Interventions  Standard open diskectomy vs nonoperative treatment individualized to the patient.

Main Outcome Measures  Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.

Results  Adherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.

Conclusions  Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis.

Trial Registration  clinicaltrials.gov Identifier: NCT00000410

Author Affiliations: Dartmouth Medical School, Hanover, NH (Drs Weinstein, T. Tosteson, Lurie, A. Tosteson, Skinner, and Abdu and Mr Hanscom); Rothman Institute at Thomas Jefferson University, Philadelphia, Pa (Dr Hilibrand); Emory University, Atlanta, Ga (Dr Boden); and Center for Cost and Outcomes Research, University of Washington, Seattle (Dr Deyo).

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