Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
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).

Who can participate?
Adults aged 18 and older who have IC.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard of care in which the treatment plan will be the same as those who decide not to enter the trial and will involve best medical therapy. Those in the second group are additionally provided with a NMES device and patients allocated to this arm are asked to use the device daily for a minimum of 30 minutes for a total period of 3 months thereafter. The device delivers electrical stimulation to create lower limb muscle contractions to improve circulation. Patients will complete diaries to record device usage and exercise attendance. Patients are invited back at 3 months, 6 months and 12 months.

What are the possible benefits and risks of participating?
The device is expected to have a direct benefit for patients with intermittent claudication. Previous studies show that the device increases blood flow in healthy people and it therefore it is expected to do the same for patients with intermittent claudication. The device has been through the national testing process and is safe to use for healthy individuals to improve circulation in the legs. The aim of this study is to look at its effect on people with Intermittent Claudication as the device has not been tested in these individuals. However, additional risks for this patient group are not anticipated.

Where is the study run from?
This study is being run by the Imperial College London (UK) and takes place in NHS trusts in the UK.

When is the study starting and how long is it expected to run for?
November 2017 to September 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Laura Burgess

Trial website

Contact information



Primary contact

Miss Laura Burgess


Contact details

Imperial College London
Section of Vascular Surgery
Room 14
4th Floor East Wing
Charing Cross Hospital
Fulham Palace Road
W6 8RF
United Kingdom
+44 203 311 5208

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific 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


NESIC Version 1.0

Study hypothesis

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).

Ethics approval

London – Surrey REC, 20/11/2017, ref: 17/LO/1918

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Diseases of arteries, arterioles and capillaries


Participants meeting the eligibility criteria are randomised into 2 arms using a computer:
Arm 1 (Control): locally available therapy.
Arm 2 (Intervention): locally available therapy + NMES device

The locally available therapy comprises best medical therapy (BMT) and either exercise advice or supervised exercise therapy (SET), depending on the centre.

Patients randomised to the NMES device are advised to complete at least one pre-programmed 30-minute session daily, to a maximum of 6 sessions for 3 months and record usage in the compliance diary.

Treatment lasts for three months, with follow-up conducted at 3, 6 and 12 months thereafter.

Intervention type



Drug names

Primary outcome measure

Absolute walking distance (AWD) is measured using treadmill testing at 3 months.

Secondary outcome measures

1. Initial claudication distance (ICD) is measured using treadmill testing at baseline, 3 month, 6 month and 12 months
2. Quality of Life (QoL) is measured using validated questionnaires (Intermittent Claudication Questionnaire (ICQ), EuroQoL 5D (EQ5D-5L), Short Form 36 (SF-36)) at baseline, 3 month, 6 month and 12 months
3. Haemodynamics are measured using Duplex ultrasonography*, Laser Doppler Flowmetery (LDF) and Ankle Brachial Pressure Index (ABPI) at baseline, 3 month, 6 month and 12 months
*performed at baseline and 3 months only.
4. Health economic assessment is measured using validated QoL questionnaires and compliance data at baseline, 3 month, 6 month and 12 months
5. Compliance with interventions is measured using patient compliance diaries and data loggers at 3 months
6. Device experience questionnaire is measured using patient device experience questionnaire at 3 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants

Planned Sample Size: 192; UK Sample Size: 192

Participant exclusion criteria

1. Severe IC requiring invasive intervention as determined by the treating clinician
2. Critical limb ischaemia as defined by the European Consensus Document
3. Co-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
4. Popliteal Entrapment Syndrome
5. Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
6. Pregnancy. Participants must be of non-childbearing potential* OR using adequate contraception for the duration of the study period and have a negative urine pregnancy test result
7. Any implanted electronic, cardiac or defibrillator device
8. Acute Deep Vein Thrombosis
9. Broken or bleeding skin including leg ulceration
10. Peripheral neuropathy
11. Recent lower limb injury or lower back pain

* defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for greater than 12 months and has an FSH greater than 40 IU/L

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St. Marys Hospital
Imperial College Healthcare NHS Trust Praed Street
W2 1NY
United Kingdom

Trial participating centre

University Hospitals Bristol Nhs Foundation Trust
Marlborough Street
Bristol Avon
United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull And East Yorkshire Hospitals NHS Trust Anlaby Road Hull North Humberside
United Kingdom

Trial participating centre

Southampton General Hospital
University Hospital Southampton NHS Foundation Trust Mailpoint 18 Tremona Road
SO16 6YD
United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust Hills Road
United Kingdom

Trial participating centre

Freeman Hospital
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
Newcastle Upon-Tyne
United Kingdom

Trial participating centre

Musgrove Park Hospital
Taunton And Somerset NHS Foundation Trust Musgrove Park Hospital
United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham University Hospitals NHS Trust Trust Headquarters Derby Road
United Kingdom

Sponsor information


Imperial College of Science, Technology and Medicine

Sponsor details

United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication and presentation of results at scientific meetings
2. Summaries of results will also be made available to Investigators for dissemination within their clinical areas (where appropriate and according to their discretion)
3. There will also be an online dissemination plan, with participants and healthcare professionals able to access results on a trial website, and appropriate use of social media (Twitter, Facebook, LinkedIn)
4. Trial participants will also be offered a mailed summary of the trial findings

IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes