Shock therapy for leg pain? tiny trial tests TENS plus coaching to get people moving

NCT ID NCT06114732

Symptom relief Sponsor: Glasgow Caledonian University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a TENS pain-relief device, combined with video coaching sessions from a physiotherapist, can help people with leg pain from peripheral artery disease (PAD) become more active. Forty-eight participants will either get the TENS device plus coaching or usual care. The goal is to see if this approach is practical and acceptable, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Transcutaneous Electrical Nerve Stimulation (TENS) device
What this could lead to: If it works, this approach could offer a practical, home-based way to reduce leg pain and improve walking ability for people with peripheral artery disease.
What could go wrong: This is a very small feasibility trial (48 people) testing whether the methods work, not whether the treatment is effective. The TENS device may not reduce pain enough to make a real difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

agnosia intermittent vascular claudication peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intermittent claudication Peripheral artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Shock therapy for leg pain? tiny trial tests TENS plus coaching to get people moving

What the study statuses mean