Condition category
Circulatory System
Date applied
27/11/2017
Date assigned
28/11/2017
Last edited
28/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
l.burgess@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Laura Burgess

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35485

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Intervention

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

Other

Phase

Drug names

Primary outcome measures

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

01/11/2017

Overall trial end date

30/09/2020

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

15/01/2018

Recruitment end date

31/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

University Hospitals Bristol Nhs Foundation Trust
Marlborough Street
Bristol Avon
BS1 3NU
United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull And East Yorkshire Hospitals NHS Trust Anlaby Road Hull North Humberside
Hull
HU3 2JZ
United Kingdom

Trial participating centre

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

Trial participating centre

Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Freeman Hospital
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
Newcastle Upon-Tyne
NE7 7DN
United Kingdom

Trial participating centre

Musgrove Park Hospital
Taunton And Somerset NHS Foundation Trust Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham University Hospitals NHS Trust Trust Headquarters Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Imperial College of Science, Technology and Medicine

Sponsor details

Kensington
London
SW7 2AZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

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

30/09/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes