Besnier Florent, Sénard Jean-Michel, Grémeaux Vincent, Riédel Mélanie, Garrigues Damien, Guiraud Thibaut, Labrunée Marc
Institute of Metabolic and Cardiovascular Diseases (I2MC) team 8, Université de Toulouse National Institute of Health and Medical Research (INSERM), Toulouse, France.
Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Centre, Saint-Orens-de-Gameville, France.
Trials. 2017 Aug 10;18(1):373. doi: 10.1186/s13063-017-1997-1.
In patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic strategies, such as transcutaneous electrical nerve stimulation (TENS), to improve the participation of PAD patients in rehabilitation programmes, and thus improve their quality of life. Our team recently tested the efficacy of a single 45-min session of 10-Hz TENS prior to walking. TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class-II PAD. We now seek to assess the efficacy of a chronic intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in Leriche-Fontaine stage-II PAD patients.
METHODS/DESIGN: This is a prospective, double-blind, multicentre, randomised, placebo-controlled trial. One hundred subjects with unilateral PAD (Leriche-Fontaine stage II) will be randomised into two groups (1:1). For the experimental group (TENS group): the treatment will consist of stimulation of the affected leg (at a biphasic frequency of 10 Hz, with a pulse width of 200 μs, maximal intensity below the motor threshold) for 45 min per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. For the control group (SHAM group): the placebo stimulation will be delivered according to the same modalities as for the TENS group but with a voltage level automatically falling to zero after 10 s of stimulation. First outcome: walking distance without pain.
transcutaneous oxygen pressure (TcPO) measured during a Strandness exercise test, peak oxygen uptake (VO peak), endothelial function (EndoPAT®), Ankle-brachial Pressure Index, Body Mass Index, lipid profile (LDL-C, HDL-C, triglycerides), fasting glycaemia, HbA1c level, and the WELCH questionnaire.
TENS-PAD is the first randomised controlled trial that uses transcutaneous electrical therapy as an adjuvant technique to improve vascular function in the treatment of PAD. If the results are confirmed, this technique could be incorporated into the routine care in cardiovascular rehabilitation centers and used in the long term by patients to improve their walking capacity.
ClinicalTrials.gov, ID: NCT02678403 . Registered on 9 February 2016.
Toulouse University Hospital.
在周围动脉疾病（PAD）患者中，由于血管性间歇性跛行导致的早期疼痛发作常常限制了步行能力的改善。因此，开发非侵入性治疗策略，如经皮电神经刺激（TENS），以提高PAD患者参与康复计划的程度，从而改善他们的生活质量，似乎是很有意义的。我们的团队最近测试了在步行前进行一次45分钟的10赫兹TENS治疗的效果。TENS显著延迟了II级PAD患者的疼痛发作，并增加了无痛步行距离。我们现在试图评估一项长期干预措施的效果，该措施包括对Leriche-Fontaine II期PAD患者每天使用TENS，持续3周（每周5天），观察其对步行距离的影响。
方法/设计：这是一项前瞻性、双盲、多中心、随机、安慰剂对照试验。100名单侧PAD（Leriche-Fontaine II期）患者将被随机分为两组（1:1）。对于实验组（TENS组）：治疗包括每天在运动康复计划前的早晨，对患侧腿部进行刺激（双相频率为10赫兹，脉冲宽度为200微秒，最大强度低于运动阈值），持续45分钟，共3周，每周5天。对于对照组（假刺激组）：安慰剂刺激将按照与TENS组相同的方式进行，但在刺激10秒后电压水平自动降至零。首要结果：无痛步行距离。
在Strandness运动试验中测量的经皮氧分压（TcPO）、峰值摄氧量（VO峰值）、内皮功能（EndoPAT®）、踝臂压力指数、体重指数、血脂谱（低密度脂蛋白胆固醇、高密度脂蛋白胆固醇、甘油三酯）、空腹血糖、糖化血红蛋白水平以及WELCH问卷。
TENS-PAD是第一项将经皮电疗法作为辅助技术来改善PAD治疗中血管功能的随机对照试验。如果结果得到证实，该技术可纳入心血管康复中心的常规护理，并供患者长期使用以提高其步行能力。
ClinicalTrials.gov，标识符：NCT02678403。于2016年2月9日注册。
图卢兹大学医院。
