A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment

Abstract

Objective: To assess the clinical efficacy of an NMES device to improve the absolute walking distance (AWD) in patients with IC, as an adjunct to the local standard care available at the study sites compared to local standard care alone. Methods: An open, multicentre, randomised controlled trial including eight participating centres in England. Sites are equally distributed between those that provide SET programmes and those that do not. Patients with IC meeting the inclusion and exclusion criteria, and providing consent will be randomised, depending on the centre type, to either NMES and locally available standard care or standard care alone. The primary endpoint, AWD, will be measured at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life assessment, compliance with the interventions, economic evaluation of the NMES device, and lower limb haemodynamic measures to further the understanding of underlying mechanisms. Recruitment is due to commence in February 2018 and will continue for a total of 15 months. The NESIC trial is funded by the UK Efficacy and Mechanism Evaluation (EME) Programme, Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. ISRCTN 18242823.