Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?
- Conditions
- Peripheral Vascular DiseasesIntermittent Claudication
- Interventions
- Device: NMES
- Registration Number
- NCT03446027
- Lead Sponsor
- Imperial College London
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device NMES Local therapy + Neuromuscular Electrical Stimulation (NMES)
- Primary Outcome Measures
Name Time Method Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups 3 months Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months
- Secondary Outcome Measures
Name Time Method Quality of Life - EuroQoL 5D (EQ5D) Health Scale Baseline, 3 month, 6 month and 12 months Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months Baseline, 3 month, 6 month and 12 months The single fibre laser optical probe of the LDF machine will be positioned on the dorsal aspect of the foot using single use adhesive pads. Flux, as a measure of superficial skin blood flow will be measured to assess whether using the device increases this measurement.
Device Experience Questionnaire - Ease of Use 3 months To report ease of device use and suggest any developments.
Device Experience Questionnaire - Used After Treatment 3 months To report ease of device use and suggest any developments.
Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups 3 months Measured by treadmill testing. ICD in meters at baseline and 3 months
Quality of Life - EuroQoL 5D (EQ5D) Health Index Baseline, 3 months, 6 months, 12 months Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Quality of Life Short Form 36 (SF-36) Mental Component Summary Baseline, 3 months, 6 months, 12 months Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months 3 months Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include time-averaged mean volume (TAMV, cm/s) to assess whether using the device increases this measurement.
Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES) 3 months Compliance with NMES device. NMES compliance data collected from the data logger fitted to device and patient diary will be combined to report overall compliance.
Device Experience Questionnaire - Increased Walk Distance 3 months To report ease of device use and suggest any developments.
Device Experience Questionnaire - Could Have Used More 3 months To report ease of device use and suggest any developments.
Quality of Life - Intermittent Claudication Questionnaire (ICQ) Baseline, 3 months, 6 months, 12 months Patient questionnaire. Used to assess change in disease-specific QoL.
Quality of Life Short Form 36 (SF-36) Physical Component Summary Baseline, 3 month, 6 month and 12 months Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months 3 months Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include volume flow (VF, cc/min) to assess whether using the device increases this measurement.
Health Economic Assessment Baseline, 3 month, 6 month and 12 months The economic analyses will compare local therapy (supervised exercise therapy (SET) or exercise advice (EA) only) versus the intervention (local therapy + Neuromuscular Electrical Stimulation, NMES) in patients with Intermittent Claudication. The analyses will be based on a (i) patient level in-trial cost-effectiveness analysis, (ii) a decision model and (iii) budget impact assessment. The in-trial analysis will calculate quality-adjusted life years (QALYs) over the one year time horizon of the trial.
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months Baseline, 3 months, 6 months and 12 months The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.
Device Experience Questionnaire - Used as Instructed 3 months To report ease of device use and suggest any developments.
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months Baseline, 3 month, 6 month and 12 months The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.
Compliance With Interventions - Exercise Advice (EA) 3 months Comparison of compliance with exercise advice as per local standard of care.
Compliance With Interventions - Supervised Exercise Therapy (SET) 3 months Comparison of compliance with SET classes.
Device Experience Questionnaire - Reduces Leg Pain 3 months To report ease of device use and suggest any developments.
Trial Locations
- Locations (11)
St George's University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
🇬🇧Bournemouth, United Kingdom
Dorset County Hospital NHS Foundation Trust
🇬🇧Dorchester, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Hull and East Yorkshire Hospitals NHS Foundation Trust
🇬🇧Hull, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom