Evaluating the benefits of a neuromuscular electrical stimulation (NMES) device in patients with intermittent claudication
| ISRCTN | ISRCTN18242823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18242823 |
| ClinicalTrials.gov number | NCT03446027 |
| Secondary identifying numbers | CPMS 35485 |
- Submission date
- 27/11/2017
- Registration date
- 28/11/2017
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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 March 2021
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Sasha Smith
sasha.smith@imperial.ac.uk
Contact information
Scientific
Imperial College London
Section of Vascular Surgery
Room 14
4th Floor East Wing
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 0203 311 5208 |
|---|---|
| l.burgess@imperial.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | NESIC Version 1.0 |
| Study objectives | 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(s) | London – Surrey REC, 20/11/2017, ref: 17/LO/1918 |
| Health condition(s) or problem(s) studied | Intermittent claudication |
| Intervention | Participants meeting the eligibility criteria are randomised into two 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 |
| 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 study start date | 01/11/2017 |
| Completion date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 192; UK Sample Size: 192 |
| Total final enrolment | 200 |
| Key inclusion criteria | 1. Capacity to provide informed consent 2. Aged 18 years 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) |
| Key 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 |
| Date of first enrolment | 15/01/2018 |
| Date of final enrolment | 20/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Praed Street
London
W2 1NY
United Kingdom
Bristol Avon
BS1 3NU
United Kingdom
Anlaby Road
Hull North Humberside
Hull
HU3 2JZ
United Kingdom
Mailpoint 18
Tremona Road
Southampton
SO16 6YD
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Freeman Road
High Heaton
Newcastle Upon-Tyne
NE7 7DN
United Kingdom
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Trust Headquarters
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
Kensington
London
SW7 2AZ
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 05/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2019 | 08/03/2021 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 25/09/2023 | 26/09/2023 | Yes | No | |
| Results article | 01/07/2023 | 21/01/2025 | Yes | No |
Editorial Notes
21/01/2025: Publication reference added.
26/09/2023: Publication reference added.
18/10/2022: The intention to publish date was changed from 03/10/2022 to 05/12/2022.
05/08/2022: The intention to publish date has been changed from 22/08/2022 to 03/10/2022.
15/06/2022: The intention to publish date was changed from 20/06/2022 to 22/08/2022.
21/04/2022: The intention to publish date was changed from 01/05/2022 to 20/06/2022.
07/03/2022: The intention to publish date was changed from 01/03/2022 to 01/05/2022.
08/12/2021: The intention to publish date was changed from 30/12/2021 to 01/03/2022.
08/03/2021: The following changes were made to the trial record:
1. The total final enrolment was added.
2. Publication reference added.
3. The ClinicalTrials.gov number was added.
4. The trial website was added.
5. The contact was changed.
16/10/2020: The recruitment end date was changed from 31/03/2020 to 20/03/2020.
06/04/2020: Due to current public health guidance, recruitment for this study has been paused.
11/02/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2020 to 31/03/2020.
2. The overall trial end date was changed from 31/07/2021 to 31/03/2021 and the plain English summary was updated to reflect this change.
3. The intention to publish date was changed from 30/11/2021 to 31/12/2021.
4. The public contact was updated and the plain English summary was updated to reflect this change.
04/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2019 to 31/01/2020.
2. The overall trial end date was changed from 30/12/2020 to 31/07/2021 and the plain English summary was updated to reflect this change.
3. The intention to publish date was changed from 30/09/2021 to 30/11/2021.
06/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2019 to 31/10/2019.
2. The overall end date was changed from 30/09/2020 to 30/12/2020.
3. The plain English summary was updated to reflect these changes.
29/03/2019: The condition has been changed from "Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Diseases of arteries, arterioles and capillaries" to "Intermittent claudication" following a request from the NIHR.
