Clinical trial NCT03446027: Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Peripheral Vascular Diseases
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility 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

Primary outcomes:
measure: Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups
timeFrame: 3 months
Secondary outcomes:
measure: Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups
timeFrame: 3 months
measure: Quality of Life - Intermittent Claudication Questionnaire (ICQ)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Quality of Life - EuroQoL 5D (EQ5D) Health Scale
timeFrame: Baseline, 3 month, 6 month and 12 months
measure: Quality of Life Short Form 36 (SF-36) Physical Component Summary
timeFrame: Baseline, 3 month, 6 month and 12 months
measure: Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months
timeFrame: 3 months
measure: Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months
timeFrame: Baseline, 3 month, 6 month and 12 months
measure: Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months
timeFrame: Baseline, 3 month, 6 month and 12 months
measure: Health Economic Assessment
timeFrame: Baseline, 3 month, 6 month and 12 months
measure: Compliance With Interventions - Exercise Advice (EA)
timeFrame: 3 months
measure: Device Experience Questionnaire - Ease of Use
timeFrame: 3 months
measure: Quality of Life - EuroQoL 5D (EQ5D) Health Index
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Quality of Life Short Form 36 (SF-36) Mental Component Summary
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months
timeFrame: 3 months
measure: Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Compliance With Interventions - Supervised Exercise Therapy (SET)
timeFrame: 3 months
measure: Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)
timeFrame: 3 months
measure: Device Experience Questionnaire - Reduces Leg Pain
timeFrame: 3 months
measure: Device Experience Questionnaire - Increased Walk Distance
timeFrame: 3 months
measure: Device Experience Questionnaire - Used as Instructed
timeFrame: 3 months
measure: Device Experience Questionnaire - Could Have Used More
timeFrame: 3 months
measure: Device Experience Questionnaire - Used After Treatment
timeFrame: 3 months
Other outcomes:
measure: Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites
timeFrame: 3 months
measure: Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT)
timeFrame: 3 months
measure: Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT)
timeFrame: 3 months
measure: Sub-group Analysis 4 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs. SET+BMT)
timeFrame: 3 months
measure: Sub-group Analysis 5 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs. NMES+BMT)
timeFrame: 3 months
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
Study officials:
affiliation: Chief Investigator
name: Professor Davies
role: PRINCIPAL_INVESTIGATOR
References: