CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
Active TENS +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03204825
NCT03204825N/ACompleted

Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID): Feasibility Randomised Controlled Trial

Glasgow Caledonian University·interventional·Posted Jul 2, 2017·Updated Oct 6, 2025

In Brief

A clinical study evaluating Active TENS, Patient-Centred Education, and 1 other intervention for Peripheral Arterial Disease and Intermittent Claudication. Completed, enrolled 95 participants across 1 site.

Detailed Summary

Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise and physical activity (PA) are central to the management of PAD and help to improve walking distances and reduce the risks associated with PAD such as heart attack and stroke. However, exercise and PA in this population is often limited due to pain. Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase walking distance in patients with PAD. Investigators have also shown that educating patients about their condition and helping them to set goals has the potential to increase PA, and quality of life. This study will examine the feasibility of designing a definitive trial that investigates whether TENS can improve the physical activity of patients with PAD when delivered alone and/or alongside a patient education programme.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartAug 1, 2017
Primary CompletionMar 24, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9 years ago

Interventions

Active TENSdevice

TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.

Patient-Centred Educationbehavioral

Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking

Placebo TENSdevice

TENS device use with setting so that the stimulation delivered is ineffective