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].). Copyright 2008 Massachusetts Medical Society.
RCT Entities:
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].). Copyright 2008 Massachusetts Medical Society.
Authors: James N Weinstein; Jon D Lurie; Tor D Tosteson; Jonathan S Skinner; Brett Hanscom; Anna N A Tosteson; Harry Herkowitz; Jeffrey Fischgrund; Frank P Cammisa; Todd Albert; Richard A Deyo Journal: JAMA Date: 2006-11-22 Impact factor: 56.272
Authors: James N Weinstein; Tor D Tosteson; Jon D Lurie; Anna N A Tosteson; Brett Hanscom; Jonathan S Skinner; William A Abdu; Alan S Hilibrand; Scott D Boden; Richard A Deyo Journal: JAMA Date: 2006-11-22 Impact factor: 56.272
Authors: James N Weinstein; Jon D Lurie; Tor D Tosteson; Brett Hanscom; Anna N A Tosteson; Emily A Blood; Nancy J O Birkmeyer; Alan S Hilibrand; Harry Herkowitz; Frank P Cammisa; Todd J Albert; Sanford E Emery; Lawrence G Lenke; William A Abdu; Michael Longley; Thomas J Errico; Serena S Hu Journal: N Engl J Med Date: 2007-05-31 Impact factor: 91.245
Authors: E A Phelan; R A Deyo; D C Cherkin; J N Weinstein; M A Ciol; W Kreuter; J F Howe Journal: Spine (Phila Pa 1976) Date: 2001-01-15 Impact factor: 3.468
Authors: Nancy J O Birkmeyer; James N Weinstein; Anna N A Tosteson; Tor D Tosteson; Jonathan S Skinner; Jon D Lurie; Richard Deyo; John E Wennberg Journal: Spine (Phila Pa 1976) Date: 2002-06-15 Impact factor: 3.468
Authors: James N Weinstein; Tor D Tosteson; Jon D Lurie; Anna Tosteson; Emily Blood; Harry Herkowitz; Frank Cammisa; Todd Albert; Scott D Boden; Alan Hilibrand; Harley Goldberg; Sigurd Berven; Howard An Journal: Spine (Phila Pa 1976) Date: 2010-06-15 Impact factor: 3.468
Authors: Mitchell K Freedman; Alan S Hilibrand; Emily A Blood; Wenyan Zhao; Todd J Albert; Alexander R Vaccaro; Christina V Oleson; Tamara S Morgan; James N Weinstein Journal: Spine (Phila Pa 1976) Date: 2011-02-15 Impact factor: 3.468
Authors: Anna N A Tosteson; Jon D Lurie; Tor D Tosteson; Jonathan S Skinner; Harry Herkowitz; Todd Albert; Scott D Boden; Keith Bridwell; Michael Longley; Gunnar B Andersson; Emily A Blood; Margaret R Grove; James N Weinstein Journal: Ann Intern Med Date: 2008-12-16 Impact factor: 25.391
Authors: Brook I Martin; Jon D Lurie; Anna N A Tosteson; Richard A Deyo; Tor D Tosteson; James N Weinstein; Sohail K Mirza Journal: Spine (Phila Pa 1976) Date: 2014-04-20 Impact factor: 3.468
Authors: Brook I Martin; Gary M Franklin; Richard A Deyo; Thomas M Wickizer; Jonathan D Lurie; Sohail K Mirza Journal: Spine J Date: 2013-11-07 Impact factor: 4.166