NESIC Version 1.0
Research type
Research Study
Full title
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.
IRAS ID
229435
Contact name
Becky Ward
Contact email
Sponsor organisation
Joint Research Compliance Office, Imperial College London
Duration of Study in the UK
3 years, 1 months, 24 days
Research summary
Summary of Research
This is a vascular randomised controlled study that will assess the benefit of using a neuromuscular electrical stimulation (NMES) device as an adjunct to the local standard care that is available at the study sites, compared to local standard care alone.
The device is expected to increase the walking distance in patients with intermittent claudication (IC), and therefore have an adjuvant 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).
There will be eight participating centres in England, equally distributed according to local therapy provision between supervised exercise therapy (SET) (4 centres) and exercise advice only (4 centres). Subject to any patient specific restrictions, all patients will also be provided with best medical therapy (BMT) in order to control for any cardiovascular risk factors.
The study is open to all patients at the participating NHS sites with a diagnosis of IC, meeting specific inclusion and exclusion criteria. Treatment will last for 3 months, with follow-up conducted at 3, 6 and 12 months thereafter.
Summary of Results
Why did we conduct this research?
Patients with intermittent claudication present with pain in the lower limbs on exercising, relieved by rest. This negatively impacts on exercise tolerance and quality-of-life.Initially, such patients should be offered best medical therapy, including exercise advice, and a supervised exercise therapy programme. Supervised exercise therapy involves leg and feet exercises supervised by healthcare professionals and, despite evidence favouring supervised versus unsupervised exercise, are underutilised in the UK. Therefore, there remains a significant difference between recommended standard care (best medical therapy and supervised exercise therapy) and ‘real-world’ standard care (best medical therapy only).
Neuromuscular electrical stimulation) devices have emerged as safe, portable and readily accessible with some evidence suggesting they can improve outcomes, including pain-free walking distance and quality-of-life. This study investigated whether a neuromuscular electrical stimulation device improved the walking distance of intermittent claudication patients compared to local standard care available (which may include supervised exercise therapy).
What did we do?
200 patients diagnosed with intermittent claudication at eleven hospitals in England took part. A computer programme randomly assigned half the patients to local standard care only, whilst the other half were given a neuromuscular electrical stimulation device which delivers electrical stimulation to leg and feet muscles through foot-pads, plus local standard care.What did we find?
There was no clear difference in maximal walking distances between those that received a device and those that didn’t. However, neuromuscular electrical stimulation improved walking distances in patients who attended a supervised exercise therapy programme (although not significant), and clearly improved walking distances in those patients with a good baseline upper walking limit. Supervised exercise therapy significantly improved walking distances.REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/1918
Date of REC Opinion
20 Nov 2017
REC opinion
Favourable Opinion