Last updated on March 2018

Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?

Brief description of study

Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation (NMES) in the management of patients with IC exists, further high quality research is required. This proposed study is vital to identify the contribution of clinical change using NMES, compared to the current gold standard recommended practice of supervised exercise therapy (SET) and, actual standard of care offered in the majority of the UK and Ireland, including best medical therapy (BMT). The device is expected to increase the walking distance in patients with intermittent claudication (IC), and therefore have a benefit on the same when provided in addition to supervised exercise programmes. It is also expected to cause a reduction in pain symptoms and reduced likelihood of major intervention in late stage peripheral arterial disease (PAD). The principal research objective is to assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device as an adjunct to the local standard care that is available at the study randomisation sites, in order to improve walking distance in patients with intermittent claudication (IC).

Clinical Study Identifier: NCT03446027

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Robert Hinchliffe

North Bristol NHS Trust
Bristol, United Kingdom
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Manjit Gohel

Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
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Ian Chetter

Hull and East Yorkshire Hospitals NHS Foundation Trust
Hull, United Kingdom
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Alun Davies

Imperial College Healthcare NHS Trust
London, United Kingdom
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Gerry Stansby

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
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Bruce Braithwaite

Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
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Nandita Pal

University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
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James Coulston

Taunton and Somerset NHS Foundation Trust
Taunton, United Kingdom
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