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

• ClinicalTrials.gov Identifier: NCT03446027
• Recruitment Status: Active, not recruiting
• First Posted: February 26, 2018
• Last Update Posted: July 16, 2021
• Sponsor: Imperial College London
• Information provided by (Responsible Party): Imperial College London

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Intermittent Claudication; Peripheral Vascular Diseases	Device: NMES	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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?
• Actual Study Start Date: February 16, 2018
• Actual Primary Completion Date: March 31, 2021
• Estimated Study Completion Date: September 30, 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; 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.
Experimental: Device; Local therapy + Neuromuscular Electrical Stimulation (NMES)	Device: NMES; NMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months.

Outcome Measures

Primary Outcome Measures :

1. Absolute walking distance (AWD) [ Time Frame: 3 months ]
   measured by treadmill testing

Secondary Outcome Measures :

1. Initial claudication distance (ICD) [ Time Frame: 3 months ]
   measured by treadmill testing
2. Quality of life - Intermittent Claudication Questionnaire (ICQ) [ Time Frame: Baseline, 3 month, 6 month and 12 months ]
   Patient questionnaire. Used to assess change in disease-specific QoL.
3. Quality of life - EuroQoL 5D (EQ5D) [ Time Frame: 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.
4. Quality of life Short Form 36 (SF-36) [ Time Frame: 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.
5. Haemodynamic assessment - Duplex ultrasonography [ Time Frame: Baseline, 3 month, 6 month and 12 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) and time-averaged mean volume (TAMV, cm/s) to assess whether using the device increases these measurements.
6. Haemodynamic assessment - Laser Doppler Flowmetry (LDF) [ Time Frame: 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.
7. Haemodynamic assessment - Laser Doppler Flowmetry (LDF) [ Time Frame: 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. Skin surface temperature will be measured to assess whether using the device increases this measurement.
8. Haemodynamic assessment - Ankle Brachial Pressure Index (ABPI) [ Time Frame: 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.
9. Health economic assessment [ Time Frame: Baseline, 3 month, 6 month and 12 months ]
   The economic analyses will compare local therapy (SET or 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.
10. Compliance with interventions [ Time Frame: 3 months ]
    Comparison of compliance with NMES device compared to SET classes. NMES compliance data collected from the data logger fitted to device and patient diary will be combined to report overall compliance.
11. Device experience questionnaire [ Time Frame: 3 months ]
    To report ease of device use and suggest any developments.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United Kingdom

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust

Bournemouth, United Kingdom

North Bristol NHS Trust

Bristol, United Kingdom, BS10 5NB

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

Dorset County Hospital NHS Foundation Trust

Dorchester, United Kingdom

Hull and East Yorkshire Hospitals NHS Foundation Trust

Hull, United Kingdom, HU3 2JZ

Imperial College Healthcare NHS Trust

London, United Kingdom, W2 1NY

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom, NE7 7DN

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG7 2RD

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom, SO16 6YD

Taunton and Somerset NHS Foundation Trust

Taunton, United Kingdom, TA1 5DA

Sponsors and Collaborators

Imperial College London

More Information

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03446027
• Other Study ID Numbers: 17HH4216
• First Posted: February 26, 2018
• Last Update Posted: July 16, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vascular Diseases; Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis