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Shock therapy for leg pain? tiny device may help PAD patients move more

NCT ID NCT03204825

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a small device called TENS, which sends mild electrical pulses to the skin, could reduce leg pain during walking in people with peripheral artery disease (PAD). It also looked at adding a patient education program to encourage more physical activity. The trial enrolled 95 participants and focused on whether a larger study is feasible, not on proving the treatment 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 and patient education program
What this could lead to
If this works, it could offer a simple, non-drug way to reduce leg pain and help people with PAD become more active.
What could go wrong
This is a small feasibility study, not a large trial. It is designed to see if a bigger study is possible, not to prove the treatment works. Results may not apply to everyone.

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

95 people

The number who actually took part.

Started

Aug 2017

Finished

Mar 2020

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 Ankle Brachial Pressure Index (ABPI) \<0.9 in at least one leg * Stable IC for ≥3 months * Walking limited primarily by claudication * Able to exercise on a treadmill * 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/ structured patient education 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/ Transient Ischaemic Attack (TIA) in the previous 6 months * Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis) * \>20% variation in baseline ACD on treadmill * 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 Motor Activity peripheral arterial disease

As listed by the trial registrant

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

Intermittent claudication Peripheral arterial disease

Contacts and locations

Locations

  • Clinical Research Facility, Queen Elizabeth University Hospital

    Glasgow, Strathcylde, G51 4TF, United Kingdom

More trials for these conditions

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