Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.
BACKGROUND
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.


METHODS
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.


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


METHODS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00000410.
Weinstein
James N
JN
Dartmouth Medical School, Hanover, NH, USA. james.n.weinstein@dartmouth.edu
Tosteson
Tor D
TD
Lurie
Jon D
JD
Tosteson
Anna N A
AN
Hanscom
Brett
B
Skinner
Jonathan S
JS
Abdu
William A
WA
Hilibrand
Alan S
AS
Boden
Scott D
SD
Deyo
Richard A
RA
D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D018592:Cross-Over Studies; D017586:Diskectomy; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000628:therapy*; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009989:Orthotic Devices; D011843:Radiculopathy; D012585:Sciatica; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D000893:Anti-Inflammatory Agents