Surgical versus nonsurgical therapy for lumbar spinal stenosis.
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].).
Weinstein
James N
JN
Dartmouth Institute for Health Policy and Clinical Practice, Department of Orthopedics, Dartmouth Medical School, Hanover, NH 03756, USA. sport@dartmouth.edu
Tosteson
Tor D
TD
Lurie
Jon D
JD
Tosteson
Anna N A
AN
Blood
Emily
E
Hanscom
Brett
B
Herkowitz
Harry
H
Cammisa
Frank
F
Albert
Todd
T
Boden
Scott D
SD
Hilibrand
Alan
A
Goldberg
Harley
H
Berven
Sigurd
S
An
Howard
H
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007796:Laminectomy; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019370:Observation; D010146:Pain / Q000209:etiology; D026741:Physical Therapy Modalities; D013130:Spinal Stenosis / Q000601:surgery / Q000628:therapy*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal