Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?

Intermittent Claudication Clinical Trial

— NESIC  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446027
• Other study ID #: 17HH4216
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• NMES
NMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months.

Locations

Country	Name	City	State
United Kingdom	The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust	Bournemouth
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Dorset County Hospital NHS Foundation Trust	Dorchester
United Kingdom	Hull and East Yorkshire Hospitals NHS Foundation Trust	Hull
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Taunton and Somerset NHS Foundation Trust	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites	Subgroup analysis 1: Right censored Tobit regression model for AWD at 3 months to assess the effects SET sites vs non-SET sites (NMES+SET+BMT & SET+BMT vs NMES+BMT & BMT).	3 months
Other	Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT)	Subgroup analysis 2: Right censored Tobit Regression model for AWD at 3 months to assess the effects of NMES in the SET sites (NMES+SET+BMT vs SET+BMT).	3 months
Other	Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT)	Subgroup analysis 3: Right censored Tobit regression model for the AWD at 3 months to assess the effects of NMES in the non-SET sites (NMES+BMT vs BMT).	3 months
Other	Sub-group Analysis 4 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs. SET+BMT)	Subgroup analysis 4: Right censored Tobit regression model for AWD at 3 months to assess the effects of (NMES+BMT) has a similar effect as (SET+BMT).	3 months
Other	Sub-group Analysis 5 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs. NMES+BMT)	Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT).	3 months
Primary	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	3 months
Secondary	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	3 months
Secondary	Quality of Life - Intermittent Claudication Questionnaire (ICQ)	Patient questionnaire. Used to assess change in disease-specific QoL.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 month, 6 month and 12 months
Secondary	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.	Baseline, 3 month, 6 month and 12 months
Secondary	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.	3 months
Secondary	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.	Baseline, 3 month, 6 month and 12 months
Secondary	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.	Baseline, 3 month, 6 month and 12 months
Secondary	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.	Baseline, 3 month, 6 month and 12 months
Secondary	Compliance With Interventions - Exercise Advice (EA)	Comparison of compliance with exercise advice as per local standard of care.	3 months
Secondary	Device Experience Questionnaire - Ease of Use	To report ease of device use and suggest any developments.	3 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	3 months
Secondary	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.	Baseline, 3 months, 6 months and 12 months
Secondary	Compliance With Interventions - Supervised Exercise Therapy (SET)	Comparison of compliance with SET classes.	3 months
Secondary	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.	3 months
Secondary	Device Experience Questionnaire - Reduces Leg Pain	To report ease of device use and suggest any developments.	3 months
Secondary	Device Experience Questionnaire - Increased Walk Distance	To report ease of device use and suggest any developments.	3 months
Secondary	Device Experience Questionnaire - Used as Instructed	To report ease of device use and suggest any developments.	3 months
Secondary	Device Experience Questionnaire - Could Have Used More	To report ease of device use and suggest any developments.	3 months
Secondary	Device Experience Questionnaire - Used After Treatment	To report ease of device use and suggest any developments.	3 months