Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
Department of Medical Rehabilitation, Faculty of Health Science and Technology, College of Medicine, University of Nigeria, Enugu, Nigeria.
Trials. 2019 Apr 16;20(1):222. doi: 10.1186/s13063-019-3307-6.
Physical activity (PA) improves functional capacity and quality of life and provides secondary prevention benefits in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC). However, pain and patient lack of knowledge are key barriers to the uptake of, and adherence to, PA recommendations. This trial will test the efficacy and feasibility of a non-invasive pain management intervention with and without patient education to improve PA in individuals with PAD and IC.
This is a randomised, controlled assessor-blinded feasibility trial with four parallel groups. Eighty adults with PAD and IC will be randomly assigned 1:1:1:1 to Active TENS (transcutaneous electrical nerve stimulation), Placebo TENS, Active TENS + Patient education or Placebo TENS + Patient education groups. All groups will continue to receive usual care over the intervention period. Participants randomised to Active TENS will receive a TENS device (preset at 120 Hz, 200 μs) and will be instructed to use the device daily at home or elsewhere for 6 weeks with a patient-determined intensity of "strong but comfortable". Placebo TENS group participants will receive the same model of TENS device and instructions for use as those in the active group, except that the stimulation dose will be safely altered to produce non-therapeutic, ineffective stimulation. Participants randomised to patient education will receive a one-off 3-h workshop of structured group education (four to five persons in each group) and three sets of twice-weekly phone calls. Efficacy outcomes will be assessed at baseline, after 6 weeks of intervention and at 3 months follow-up. Absolute claudication distance using the Gardner treadmill protocol will be assessed as the primary outcome. Secondary outcomes will assess initial claudication distance, daily PA and patient-reported outcomes including quality of life, pain self-efficacy, depression, disease perception and walking impairment pain intensity and quality. Feasibility outcomes will assess rates of recruitment, retention and adherence. Focus groups with participants at the end of the trial will explore the acceptability of the interventions.
This trial will determine the efficacy and feasibility of using a low-cost, CE-marked non-invasive pain management modality delivered with or without a patient-centred education intervention to improve PA in individuals with PAD and IC.
ClinicalTrials.gov, NCT03204825 . Registered on 2 July 2017.
体力活动（PA）可改善功能能力和生活质量，并为外周动脉疾病（PAD）和间歇性跛行（IC）患者提供二级预防益处。然而，疼痛和患者缺乏知识是接受和坚持 PA 建议的关键障碍。本试验将测试一种非侵入性疼痛管理干预措施，结合和不结合患者教育，以改善 PAD 和 IC 患者的 PA 的疗效和可行性。
这是一项随机、对照、评估者盲法的可行性试验，有四个平行组。80 名 PAD 和 IC 成人将被随机分配 1:1:1:1 至主动经皮神经电刺激（TENS）、安慰剂 TENS、主动 TENS + 患者教育或安慰剂 TENS + 患者教育组。所有组将在干预期间继续接受常规护理。随机分配至主动 TENS 组的参与者将接受 TENS 设备（预设 120Hz，200μs），并将被指示每天在家或其他地方使用该设备 6 周，使用患者确定的“强但舒适”强度。安慰剂 TENS 组参与者将接受与主动组相同型号的 TENS 设备和使用说明，只是刺激剂量将被安全地改变以产生非治疗性、无效的刺激。随机分配至患者教育组的参与者将接受一次 3 小时的结构化小组教育（每组 4-5 人）和三次每周两次的电话随访。疗效结果将在基线、干预 6 周后和 3 个月随访时进行评估。使用 Gardner 跑步机方案评估绝对跛行距离作为主要结局。次要结局将评估初始跛行距离、日常 PA 和患者报告的结果，包括生活质量、疼痛自我效能、抑郁、疾病感知和行走障碍疼痛强度和质量。可行性结局将评估招募、保留和依从性的发生率。试验结束时的焦点小组将探讨干预措施的可接受性。
本试验将确定使用低成本、CE 标记的非侵入性疼痛管理方式与或不与以患者为中心的教育干预相结合，以改善 PAD 和 IC 患者 PA 的疗效和可行性。
ClinicalTrials.gov，NCT03204825。于 2017 年 7 月 2 日注册。
