Does neuromuscular electrical stimulation improve the absolute walking distance in patients with intermittent claudication (nesic) compared to best available treatment? A multicentre randomised controlled study

Imperial College of Science, Technology and Medicine0 个研究点目标入组 200 人开始时间: 2017年11月28日最近更新: 2023年10月9日

试验速览

2019 Protocol article in https://doi.org/10.1016/j.jvs.2018.10.046 protocol (added 08/03/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37748866/ (added 26/09/2023)

•1. Capacity to provide informed consent
•2. Aged 18 years or above
•3. Positive Edinburgh Claudication Questionnaire
•4. ABPI <0.9 OR positive stress test (fall in ankle pressure >30mmHg, 40 secs post 1 min treadmill at 10% gradient, 4 km/h)

•1. Severe IC requiring invasive intervention as determined by the treating clinician
•2. Critical limb ischaemia as defined by the European Consensus Document
•3. Co-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
•4. Popliteal Entrapment Syndrome
•5. Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
•6. Pregnancy. Participants must be of non-childbearing potential* OR using adequate contraception for the duration of the study period and have a negative urine pregnancy test result
•7. Any implanted electronic, cardiac or defibrillator device
•8. Acute Deep Vein Thrombosis
•9. Broken or bleeding skin including leg ulceration
•10. Peripheral neuropathy
•11. Recent lower limb injury or lower back pain
•* defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for greater than 12 months and has an FSH greater than 40 IU/L

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