腰椎管狭窄症的手术治疗与非手术治疗：一项随机试验。
Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial.
作者信息
Delitto Anthony, Piva Sara R, Moore Charity G, Fritz Julie M, Wisniewski Stephen R, Josbeno Deborah A, Fye Mark, Welch William C
出版信息
Ann Intern Med. 2015 Apr 7;162(7):465-73. doi: 10.7326/M14-1420.
BACKGROUND
Primary care management decisions for patients with symptomatic lumbar spinal stenosis (LSS) are challenging, and nonsurgical guidance is limited by lack of evidence.
OBJECTIVE
To compare surgical decompression with physical therapy (PT) for LSS and evaluate sex differences.
DESIGN
Multisite randomized, controlled trial. (ClinicalTrials.gov: NCT00022776).
SETTING
Neurologic and orthopedic surgery departments and PT clinics.
PARTICIPANTS
Surgical candidates with LSS aged 50 years or older who consented to surgery.
INTERVENTION
Surgical decompression or PT.
MEASUREMENTS
Primary outcome was physical function score on the Short Form-36 Health Survey at 2 years assessed by masked testers.
RESULTS
The study took place from November 2000 to September 2007. A total of 169 participants were randomly assigned and stratified by surgeon and sex (87 to surgery and 82 to PT), with 24-month follow-up completed by 74 and 73 participants in the surgery and PT groups, respectively. Mean improvement in physical function for the surgery and PT groups was 22.4 (95% CI, 16.9 to 27.9) and 19.2 (CI, 13.6 to 24.8), respectively. Intention-to-treat analyses revealed no difference between groups (24-month difference, 0.9 [CI, -7.9 to 9.6]). Sensitivity analyses using causal-effects methods to account for the high proportion of crossovers from PT to surgery (57%) showed no significant differences in physical function between groups.
LIMITATION
Without a control group, it is not possible to judge success attributable to either intervention.
CONCLUSION
Surgical decompression yielded similar effects to a PT regimen among patients with LSS who were surgical candidates. Patients and health care providers should engage in shared decision-making conversations that include full disclosure of evidence involving surgical and nonsurgical treatments for LSS.
PRIMARY FUNDING SOURCE
National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases.
背景
有症状的腰椎管狭窄症（LSS）患者的初级保健管理决策具有挑战性，且非手术指导因缺乏证据而受限。
目的
比较LSS患者手术减压与物理治疗（PT）的效果，并评估性别差异。
设计
多中心随机对照试验。（ClinicalTrials.gov：NCT00022776）。
地点
神经外科和骨科手术科室以及PT诊所。
参与者
年龄在50岁及以上且同意手术的LSS手术候选者。
干预措施
手术减压或PT。
测量指标
主要结局是由盲法测试者在2年时评估的简短健康调查问卷36项身体功能得分。
结果
研究于2000年11月至2007年9月进行。共有169名参与者被随机分配，并按外科医生和性别分层（87人接受手术，82人接受PT），手术组和PT组分别有74名和73名参与者完成了24个月的随访。手术组和PT组身体功能的平均改善分别为22.4（95%CI，16.9至27.9）和19.2（CI，13.6至24.8）。意向性分析显示两组之间无差异（24个月差异，0.9 [CI，-7.9至9.6]）。使用因果效应方法进行的敏感性分析考虑到从PT转为手术的比例较高（57%），结果显示两组之间身体功能无显著差异。
局限性
没有对照组，无法判断任何一种干预措施的成功与否。
结论
对于LSS手术候选患者，手术减压与PT方案产生的效果相似。患者和医疗保健提供者应进行共同决策对话，包括充分披露涉及LSS手术和非手术治疗的证据。
主要资金来源
美国国立卫生研究院以及国立关节炎和肌肉骨骼及皮肤病研究所。
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