ImportanceIntermittent lower limb claudication limits function and quality of life. Supervised exercise programs are not readily available, and a noninvasive alternative is needed.ObjectiveTo assess extracorporeal corporeal shockwave therapy in improving quality of life in patients with claudication.Design, Setting, and ParticipantsIn this double-blind, placebo-controlled randomized clinical trial, patients in the outpatient setting at a single tertiary center for vascular surgery were randomized in a 1:1 ratio to extracorporeal shockwave therapy or placebo therapy with no shockwaves delivered. Recruitment was between June 2015 and January 2020, with 12-week follow-up ending in March 2020. A convenience sample of patients with claudication and conservative treatment requirements who refused or were unable to participate in supervised exercise were eligible. Patients receiving anticoagulation therapy or with an active cancer were excluded. Of 522 patients screened, 389 were eligible, 138 were enrolled, and 110 completed follow-up and were included in the primary analysis. Statistical analysis was completed by May 2021.InterventionIn the intervention group, patients received 100 impulses of 0.1mJ/mm/cm2 in an area of the gastrocnemius muscle 3 times weekly for 3 weeks. The steps for treatment were replicated for the control group without delivering the treatment.Main Outcomes and MeasuresThe primary outcome was the Physical Functioning domain of the 36-item Short-Form Quality of Life Questionnaire at 12-week follow-up. Secondary outcomes included walking distances, ankle brachial pressure index, and other quality-of-life measures.ResultsOf 138 patients recruited and randomized, 92 (67%) were male, and the mean (SD) age of the study population was 67 (9.6) years. The intervention group had a significantly higher physical function score at 12 weeks (estimated median difference 3.8; 95% CI, 0.0-7.7; P = .03). However, this significance did not remain when adjusting for covariates. At 12 weeks, the intervention group had significantly longer pain-free and maximum walking distances (pain-free estimated median difference, 34.1, 95% CI, 11.4-56.8; P = .004; maximum estimated median difference, 51.4; 95% CI, 10.7-86.5; P = .01).Conclusions and RelevanceTo our knowledge, this is the first double-blind, placebo-controlled, randomized clinical trial to consider extracorporeal shockwave therapy for the management of intermittent claudication. It demonstrated efficacy for walking distances, may have a positive effect on quality of life, and may provide a safe, noninvasive alternative therapy for patients with intermittent claudication.Trial RegistrationClinicalTrials.gov Identifier: NCT02652078

中文翻译：

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体外冲击波治疗间歇性跛行和生活质量

重要性间歇性下肢跛行限制功能和生活质量。有监督的锻炼计划并不容易获得，需要一种无创替代方案。目的评估体外冲击波疗法在改善跛行患者生活质量方面的作用。设计、设置和参与者在这项双盲、安慰剂对照随机临床试验中，患者在单一三级血管外科中心的门诊患者中，患者以 1:1 的比例随机接受体外冲击波治疗或不使用冲击波的安慰剂治疗。招募时间为 2015 年 6 月至 2020 年 1 月，为期 12 周的随访于 2020 年 3 月结束。拒绝或无法参加监督锻炼的跛行和保守治疗要求患者的方便样本符合资格。接受抗凝治疗或患有活动性癌症的患者被排除在外。在筛选的 522 名患者中，389 名患者符合资格，138 名患者入组，110 名患者完成随访并纳入主要分析。统计分析于2021年5月完成。干预干预组患者接受100次0.1mJ/mm/cm脉冲2每周 3 次，持续 3 周。对照组重复治疗步骤，但不进行治疗。主要结果和测量主要结果是 12 周随访时 36 项简短生活质量问卷的身体功能领域。次要结局包括步行距离、踝臂压力指数和其他生活质量指标。 结果 在招募和随机化的 138 名患者中，92 名 (67%) 为男性，研究人群的平均 (SD) 年龄为 67 岁 (9.6 ） 年。干预组在 12 周时的身体功能评分显着较高（估计中位数差异 3.8；95% CI，0.0-7.7；磷= .03)。然而，在调整协变量时，这种显着性并没有保留。第 12 周时，干预组的无痛步行距离和最大步行距离显着更长（无痛估计中位差，34.1，95% CI，11.4-56.8；磷= .004；最大估计中位数差异，51.4； 95% CI，10.7-86.5；磷= .01). 结论和相关性据我们所知，这是第一个考虑体外冲击波疗法治疗间歇性跛行的双盲、安慰剂对照、随机临床试验。它证明了步行距离的有效性，可能对生活质量产生积极影响，并可能为间歇性跛行患者提供安全、无创的替代疗法。试验注册ClinicalTrials.gov 标识符：NCT02652078