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Remote physiotherapy and a TENS device for intermittent claudication

Tests remote physiotherapy and TENS in people with intermittent claudication.

Key facts

Who runs it
Glasgow Caledonian University
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication
Status
Recruiting
People taking part
48 people, planned
Started
29 Jan 2024
Expected to end
1 Dec 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Walking exercise behaviour change intervention + TENS
Record updated
2 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral arterial disease (narrowed leg arteries) who get leg pain when walking (intermittent claudication). It tests phone or video physiotherapy sessions plus a TENS pain device, compared with usual care.

Age
18 Years and older
Sex
All
Disease stage
Symptomatic peripheral arterial disease with resting ABPI <0.9 in at least one leg. Claudication must be stable for ≥3 months and must be the main thing limiting walking.
Earlier treatment
People who have used TENS for PAD before cannot join.
Biomarker or test result
Resting ABPI (ankle-brachial pressure index, a blood pressure test comparing ankle and arm) <0.9 in at least one leg.

Main reasons for not taking part

  • Surgery or a procedure inside the arteries planned for PAD within the next 3 months
  • Critical limb ischaemia (severe loss of blood flow to the leg)
  • Reasons TENS cannot be used, such as epilepsy, skin conditions, pacemakers or implanted electrical pumps, or not being able to apply TENS yourself
  • Needing walking aids, including artificial limbs
  • Major surgery, heart attack, stroke or TIA in the previous 6 months

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI <0.9 in at least one leg
  • Stable IC for ≥3 months
  • Walking limited primarily by claudication
  • Able to read and speak English to a level allowing satisfactory completion of the study procedures
  • Able to provide written informed consent for participation

Who cannot take part

  • Planned surgical or endovascular intervention for PAD within the next 3 months
  • Previous experience of using TENS for PAD
  • Major surgery, myocardial infarction or stroke/ TIA in the previous 6 months
  • Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS independently
  • Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis, respiratory conditions)
  • Critical limb ischaemia
  • The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
  • Patients who require walking aids including artificial limbs
  • Severe peripheral neuropathies above the ankle
  • Participation in another research protocol

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Peripheral Arterial Disease (PAD) is a common vascular disease which commonly causes limb pain and reduced exercise tolerance termed Intermittent Claudication (IC). People with PAD and IC have impaired quality of life, reduced walking ability, and increased mortality compared to those who do not have the condition.

Read full original descriptionShow less

Improving physical activity (PA) is important in individuals with IC it can improve function, morbidity and mortality rates. While supervised exercise classes are recommended by healthcare authorities they are geographically sparse, and not always accessible due to individuals walking limitations. While home-based exercise can be accessible and improve walking ability, it can be challenging for people with IC to initially plan, conduct, and stay motivated to complete a walking program unsupported, especially when they experience limb pain when walking.

Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive pain management device, with aims to improve pain and walking distances in patients with IC may be an acceptable modality alongside advice and support from a physiotherapist to overcome these challenges. Investigators have also shown that motivational interviewing, education, and goal-setting with a physiotherapist (physical therapist) has the potential to increase PA, and quality of life.

This study aims to conduct a feasibility trial of four telehealth physiotherapy sessions, alongside the provision of a CE-marked TENS device to reduce limb pain during physical activity. This will be compared to the usual care offered in NHS Lanarkshire

The 2 groups in the trial

  • Walking exercise behaviour change intervention + TENSTreatment being tested

    Participants in the Intervention groups will be asked to attend four telehealth appointments with a physiotherapist. They will also be provided with a TENS machine and training at the baseline appointment on how to use it. They will be instructed to use it daily as their symptoms require for 12 weeks. The device will be set at High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').

  • Usual Care controlNo study treatment, for comparison

    Usual Care at NHS Lanarkshire Vascular Services and/or Intermittent Claudication service.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial
Plain-language title
Remote physiotherapy and a TENS device for intermittent claudicationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
2 September 2025