Cayton Thomas, Harwood Amy E, Smith George E, Totty Joshua P, Carradice Daniel, Chetter Ian C
Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK.
Trials. 2017 Mar 6;18(1):104. doi: 10.1186/s13063-017-1844-4.
Peripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients' walking ability in terms of maximum walking distance (MWD) and pain-free walking distance (PFWD). Research has suggested extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue; therefore, our objective is to assess the tolerability and efficacy of ESWT as a novel treatment of intermittent claudication.
METHODS/DESIGN: Patients with unilateral claudication will be randomised to receive either ESWT (PiezoWave 2 shockwave system) or sham treatment to the calf muscle bulk three times per week for 3 weeks. All patients are blinded to treatment group, and all assessments will be performed by a masked assessor. Treatment tolerability using a visual analogue scale, ankle-brachial pressure index, MWD, PFWD and safety will all be formally assessed as outcome measures at baseline and at 4, 8 and 12 weeks follow-up.
This trial will be the first of its kind in terms of methodology in relation to ESWT for intermittent claudication. A double-masked randomised controlled trial will provide useful information about the potential for the use of ESWT as a non-invasive treatment option and the need for further robust research.
ClinicalTrials.gov, NCT02652078 . Registered on 17 October 2014.
外周动脉疾病（PAD）在人群中的患病率为4.6%，间歇性跛行（IC）是最早出现且最常见的症状之一。PAD对患者的行走能力在最大行走距离（MWD）和无痛行走距离（PFWD）方面有不利影响。研究表明，体外冲击波疗法（ESWT）可能会在治疗组织中诱导血管生成；因此，我们的目标是评估ESWT作为间歇性跛行新疗法的耐受性和疗效。
方法/设计：单侧跛行患者将被随机分组，接受ESWT（PiezoWave 2冲击波系统）或假治疗，每周对小腿肌肉进行3次治疗，持续3周。所有患者均不知自己所属治疗组，所有评估将由一名盲法评估者进行。使用视觉模拟量表、踝臂压力指数、MWD、PFWD评估治疗耐受性，并在基线以及随访4周、8周和12周时正式评估安全性作为结果指标。
就ESWT治疗间歇性跛行的方法而言，本试验将是同类试验中的首个。一项双盲随机对照试验将提供关于ESWT作为一种非侵入性治疗选择的潜力以及进一步开展有力研究必要性的有用信息。
ClinicalTrials.gov，NCT02652078。于2014年10月17日注册。
