A Multicenter Randomised Controlled Study: Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication (NESIC) Compared to Best Available Treatment?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 200
- Locations
- 19
- Primary Endpoint
- Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups
Time Frame: 3 months
Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months
Secondary Outcomes
- Quality of Life - EuroQoL 5D (EQ5D) Health Scale(Baseline, 3 month, 6 month and 12 months)
- Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months(Baseline, 3 month, 6 month and 12 months)
- Device Experience Questionnaire - Ease of Use(3 months)
- Device Experience Questionnaire - Used After Treatment(3 months)
- Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups(3 months)
- Quality of Life - EuroQoL 5D (EQ5D) Health Index(Baseline, 3 months, 6 months, 12 months)
- Quality of Life Short Form 36 (SF-36) Mental Component Summary(Baseline, 3 months, 6 months, 12 months)
- Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months(3 months)
- Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)(3 months)
- Device Experience Questionnaire - Increased Walk Distance(3 months)
- Device Experience Questionnaire - Could Have Used More(3 months)
- Quality of Life - Intermittent Claudication Questionnaire (ICQ)(Baseline, 3 months, 6 months, 12 months)
- Quality of Life Short Form 36 (SF-36) Physical Component Summary(Baseline, 3 month, 6 month and 12 months)
- Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months(3 months)
- Health Economic Assessment(Baseline, 3 month, 6 month and 12 months)
- Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months(Baseline, 3 months, 6 months and 12 months)
- Device Experience Questionnaire - Used as Instructed(3 months)
- Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months(Baseline, 3 month, 6 month and 12 months)
- Compliance With Interventions - Exercise Advice (EA)(3 months)
- Compliance With Interventions - Supervised Exercise Therapy (SET)(3 months)
- Device Experience Questionnaire - Reduces Leg Pain(3 months)