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

Imperial College London

Status: Completed

Conditions: Peripheral Vascular Diseases; Intermittent Claudication

Treatments: Device: NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT03446027

17HH4216

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Severe IC requiring invasive intervention as determined by the treating clinician
• Critical limb Ischaemia as defined by the European Consensus Document
• Co-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
• Popliteal entrapment syndrome
• Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
• Pregnancy
• Any implanted electronic, cardiac or defibrillator device
• Acute deep vein thrombosis
• Broken or bleeding skin including leg ulceration
• Peripheral neuropathy
• Recent lower limb injury or lower back pain

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control

No Intervention group

Description:

There will be no change to the local site standard of care for patients with IC attributed to participation in this trial. Those sites with Supervised Exercise Therapy (SET) will continue to provide this intervention as per their normal standard of care and locally agreed protocol.

Device

Experimental group

Description:

Local therapy + Neuromuscular Electrical Stimulation (NMES)

Treatment:

Device: NMES