Intermittent ClaudicationNESICNCT03446027
Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?
A study testing NMES in people with Intermittent Claudication and Peripheral Vascular Diseases, run by Imperial College London at 11 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Peripheral Vascular Diseases
- What is being tested?
- NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 16 Feb 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Bournemouth
North Bristol NHS Trust
Bristol, BS10 5NB
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Dorset County Hospital NHS Foundation Trust
Dorchester
Hull and East Yorkshire Hospitals NHS Foundation Trust
Hull, HU3 2JZ
Imperial College Healthcare NHS Trust
London, W2 1NY
St George's University Hospitals NHS Foundation Trust
London
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2RD
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA
About this study
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?
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).
- Being tested
- NMES
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
NMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Device | Experimental | Local therapy + Neuromuscular Electrical Stimulation (NMES) Receives: Device: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups
Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months
Measured: 3 months
Secondary outcomes (21)
Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups
Measured by treadmill testing. ICD in meters at baseline and 3 months
Measured: 3 months
Quality of Life - Intermittent Claudication Questionnaire (ICQ)
Patient questionnaire. Used to assess change in disease-specific QoL.
Measured: Baseline, 3 months, 6 months, 12 months
Quality of Life - EuroQoL 5D (EQ5D) Health Scale
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Measured: Baseline, 3 month, 6 month and 12 months
Quality of Life Short Form 36 (SF-36) Physical Component Summary
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Measured: Baseline, 3 month, 6 month and 12 months
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 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.
Measured: 3 months
Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline 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.
Measured: Baseline, 3 month, 6 month and 12 months
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline 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.
Measured: Baseline, 3 month, 6 month and 12 months
Health Economic Assessment
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.
Measured: Baseline, 3 month, 6 month and 12 months
Compliance With Interventions - Exercise Advice (EA)
Comparison of compliance with exercise advice as per local standard of care.
Measured: 3 months
Device Experience Questionnaire - Ease of Use
To report ease of device use and suggest any developments.
Measured: 3 months
Quality of Life - EuroQoL 5D (EQ5D) Health Index
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Measured: Baseline, 3 months, 6 months, 12 months
Quality of Life Short Form 36 (SF-36) Mental Component Summary
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Measured: Baseline, 3 months, 6 months, 12 months
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 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.
Measured: 3 months
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline 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.
Measured: Baseline, 3 months, 6 months and 12 months
Compliance With Interventions - Supervised Exercise Therapy (SET)
Comparison of compliance with SET classes.
Measured: 3 months
Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)
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.
Measured: 3 months
Device Experience Questionnaire - Reduces Leg Pain
To report ease of device use and suggest any developments.
Measured: 3 months
Device Experience Questionnaire - Increased Walk Distance
To report ease of device use and suggest any developments.
Measured: 3 months
Device Experience Questionnaire - Used as Instructed
To report ease of device use and suggest any developments.
Measured: 3 months
Device Experience Questionnaire - Could Have Used More
To report ease of device use and suggest any developments.
Measured: 3 months
Device Experience Questionnaire - Used After Treatment
To report ease of device use and suggest any developments.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start16 Feb 2018
- Primary completion31 Mar 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Davies, Principal investigator, Chief Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446027
- Sponsor's protocol ID
- 17HH4216
- Acronym
- NESIC
- Status last verified
- Apr 2024
- First submitted
- 8 Jan 2018
- Last updated
- 11 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03446027
- Acronym / sponsor ID
- NESIC / 17HH4216
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Posted 10 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Device | Experimental | Device: NMESLocal therapy + Neuromuscular Electrical Stimulation (NMES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESNMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months. | Device | Device |
Primary outcome
Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups
Time frame: 3 months
Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months
21 secondary outcomes
Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups
Time frame: 3 months
Quality of Life - Intermittent Claudication Questionnaire (ICQ)
Time frame: Baseline, 3 months, 6 months, 12 months
Quality of Life - EuroQoL 5D (EQ5D) Health Scale
Time frame: Baseline, 3 month, 6 month and 12 months
Quality of Life Short Form 36 (SF-36) Physical Component Summary
Time frame: Baseline, 3 month, 6 month and 12 months
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months
Time frame: 3 months
Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months
Time frame: Baseline, 3 month, 6 month and 12 months
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months
Time frame: Baseline, 3 month, 6 month and 12 months
Health Economic Assessment
Time frame: Baseline, 3 month, 6 month and 12 months
Compliance With Interventions - Exercise Advice (EA)
Time frame: 3 months
Device Experience Questionnaire - Ease of Use
Time frame: 3 months
Quality of Life - EuroQoL 5D (EQ5D) Health Index
Time frame: Baseline, 3 months, 6 months, 12 months
Quality of Life Short Form 36 (SF-36) Mental Component Summary
Time frame: Baseline, 3 months, 6 months, 12 months
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months
Time frame: 3 months
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months
Time frame: Baseline, 3 months, 6 months and 12 months
Compliance With Interventions - Supervised Exercise Therapy (SET)
Time frame: 3 months
Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)
Time frame: 3 months
Device Experience Questionnaire - Reduces Leg Pain
Time frame: 3 months
Device Experience Questionnaire - Increased Walk Distance
Time frame: 3 months
Device Experience Questionnaire - Used as Instructed
Time frame: 3 months
Device Experience Questionnaire - Could Have Used More
Time frame: 3 months
Device Experience Questionnaire - Used After Treatment
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Davies principal investigator
Chief Investigator
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES in people with Intermittent Claudication and Peripheral Vascular Diseases, run by Imperial College London at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.