Surgical versus nonsurgical therapy for lumbar spinal stenosis.
Surgical versus nonsurgical therapy for lumbar spinal stenosis.
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DOI：
10.1056/nejmoa0707136
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发表时间：
2008-02-21
影响因子：
158.5
通讯作者：
An, Howard
中科院分区：
文献类型：
--
作者：
Weinstein, James N.;Tosteson, Tor D.;An, Howard
BackgroundSurgery for spinal stenosis is widely performed，but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.MethodsSurgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolithesis（as confirmed on imaging）were enrolled in either a randomized cohort or a observational cohort at 13 U.S. spine clinics.治疗方法为减压手术或常规非手术治疗。主要结果是在6周，3个月，6个月，1和2 years.ResultsA共289例患者参加了随机队列，365例患者参加了观察队列中的身体疼痛和身体功能的措施的医疗结果研究36项简表一般健康调查（SF-36）和修改后的奥斯韦斯特里残疾指数。在2年时，67%的随机分配到手术组的患者接受了手术，而43%的随机分配到非手术治疗组的患者也接受了手术。尽管不依从性水平较高，但随机队列的意向治疗分析显示，SF-36量表上的躯体疼痛治疗效果显著支持手术，较基线变化的平均差异为7.8（95%置信区间，1.5 - 14.1）;然而，身体功能或奥斯韦斯特里残疾指数评分无显著差异。作为治疗分析，合并两个队列，并调整潜在的混杂因素，显示了一个显着的优势，手术3个月的所有主要成果，这些变化仍然显着在2 years.ConclusionsIn相结合的治疗分析，接受手术的患者表现出显着更多的改善，在所有的主要成果比谁是非手术治疗的患者。（ClinicalTrials.gov编号，NCT 00000411。）
BackgroundSurgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.MethodsSurgical 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.ResultsA 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.ConclusionsIn 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.)