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

NCT03446027 | Completed Results DMC

• 1 other identifier: 17HH4216
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 11

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).

Conditions

Intermittent Claudication; Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups

  3 months

• Quality of Life - Intermittent Claudication Questionnaire (ICQ)

  Baseline, 3 months, 6 months, 12 months

• Quality of Life - EuroQoL 5D (EQ5D) Health Scale

  Baseline, 3 month, 6 month and 12 months

• Quality of Life Short Form 36 (SF-36) Physical Component Summary

  Baseline, 3 month, 6 month and 12 months

• Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months

  3 months

Other Outcomes (5)

• Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites

  3 months

• Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT)

  3 months

• Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT)

  3 months

Study Arms (2)

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)

Device: NMES

Interventions

NMES DEVICE

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

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (11)

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust

Bournemouth, United Kingdom

Location

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Dorset County Hospital NHS Foundation Trust

Dorchester, United Kingdom

Location

Hull and East Yorkshire Hospitals NHS Foundation Trust

Hull, HU3 2JZ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2RD, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We did not stratify by baseline absolute walking distance AWD for the primary outcome analysis. Only 160 patients had analysable primary outcome data due to missing treadmill data. Absence of a sham device comparator.

Results Point of Contact

• Title: Laura Burgess
• Organization: Imperial College London

l.burgess@imperial.ac.uk

0203 311 5208

Study Officials

• Professor Davies

  Chief Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 26, 2018
• Study Start: February 16, 2018
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: April 11, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (11)