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全面非手术治疗与自我护理改善腰椎管狭窄症患者的步行能力:一项随机试验。

Comprehensive Nonsurgical Treatment Versus Self-directed Care to Improve Walking Ability in Lumbar Spinal Stenosis: A Randomized Trial.

机构信息

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Rebecca MacDonald Centre for Arthritis & Autoimmune Disease, Mount Sinai Hospital, Toronto, Ontario, Canada.

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; Faculty of Health Sciences, University of Ontario Institute of Technology and UOIT-CMCC Centre for Disability Prevention and Rehabilitation, Toronto, Ontario, Canada.

出版信息

Arch Phys Med Rehabil. 2018 Dec;99(12):2408-2419.e2. doi: 10.1016/j.apmr.2018.05.014. Epub 2018 Jun 20.

Abstract

OBJECTIVES

To compare the effectiveness of a comprehensive nonsurgical training program to a self-directed approach in improving walking ability in lumbar spinal stenosis (LSS).

DESIGN

Randomized controlled trial.

SETTING

Academic hospital outpatient clinic.

PARTICIPANTS

Participants (N=104) with neurogenic claudication and imaging confirmed LSS were randomized. The mean age was 70.6 years, 57% were women, 84% had leg symptoms for >12 months, and the mean maximum walking capacity was 328.7 m.

INTERVENTIONS

A 6-week structured comprehensive training program or a 6-week self-directed program.

MAIN OUTCOME MEASURES

Continuous walking distance in meters measured by the Self-Paced Walk Test (SPWT) and proportion of participants achieving at least 30% improvement (minimally clinically important difference [MCID]) in the SPWT at 6 months. Secondary outcomes included the Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI), ODI walk score, and the Short-Form General Health Survey subscales.

RESULTS

A total of 48 versus 51 participants who were randomized to comprehensive (n=51) or self-directed (n=53) treatment, respectively, received the intervention and 89% of the total study sample completed the study. At 6 months, the adjusted mean difference in walking distance from baseline was 421.0 m (95% confidence interval [95% CI], 181.4-660.6), favoring the comprehensive program and 82% of participants in the comprehensive group and 63% in the self-directed group achieved the MCID (adjusted relative risk, 1.3; 95% CI, 1.0-1.7; P=.03). Both primary treatment effects persisted at 12 months favoring the comprehensive program. At 6 months, the ODI walk score and at 12 months the ZCQ, Medical Outcomes Study 36-Item Short-Form Health Survey-physical function and -bodily pain scores showed greater improvements favoring the comprehensive program.

CONCLUSIONS

A comprehensive conservative program demonstrated superior, large, and sustained improvements in walking ability and can be a safe nonsurgical treatment option for patients with neurogenic claudication due to LSS.

摘要

目的

比较综合非手术训练计划与自我指导方法在改善腰椎管狭窄症(LSS)患者步行能力方面的效果。

设计

随机对照试验。

地点

学术医院门诊。

参与者

参与者(N=104)患有神经源性跛行和影像学证实的 LSS,并随机分组。平均年龄为 70.6 岁,57%为女性,84%的腿部症状持续时间>12 个月,平均最大步行距离为 328.7 米。

干预措施

6 周的结构化综合训练计划或 6 周的自我指导计划。

主要观察指标

连续步行距离(米),采用自我定速步行测试(SPWT)测量,6 个月时 SPWT 至少改善 30%(最小临床重要差异 [MCID])的参与者比例。次要结局包括苏黎世跛行问卷(ZCQ)、Oswestry 残疾指数(ODI)、ODI 步行评分和简明健康调查量表子量表。

结果

共 48 名参与者随机分配至综合治疗组(n=51),51 名参与者随机分配至自我指导治疗组(n=53),分别接受干预治疗,89%的总研究样本完成了研究。6 个月时,从基线开始的步行距离的调整平均差异为 421.0 米(95%置信区间 [95%CI],181.4-660.6),有利于综合治疗组,82%的综合治疗组和 63%的自我指导治疗组达到 MCID(调整后的相对风险,1.3;95%CI,1.0-1.7;P=.03)。主要治疗效果在 12 个月时仍倾向于综合治疗组。6 个月时,ODI 步行评分和 12 个月时,ZCQ、医疗结局研究 36 项简明健康调查量表-生理功能和-躯体疼痛评分均显示出更大的改善,有利于综合治疗组。

结论

综合保守治疗方案在改善步行能力方面表现出优越、显著且持久的效果,对于因 LSS 导致神经源性跛行的患者来说,可以作为一种安全的非手术治疗选择。

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