Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID) (PrEPAID)

September 16, 2025 updated by: Glasgow Caledonian University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Peripheral Arterial disease (PAD) affects 2.7 million people in the United Kingdom (UK). The most common symptom that patients experience is Intermittent Claudication (IC), which is pain in the buttock, calf or thigh precipitated by exercise and relieved by rest. The underlying cause of PAD is atherosclerosis, which leads to arterial stenosis, inadequate blood flow and build-up of lactic acid during exercise. Patients with IC have impaired quality of life due to reduced physical capacity. Furthermore, due to the diffuse nature of atherosclerosis and the involvement of other arterial beds, they have 3-4 times increased mortality compared to age and sex matched controls.

Patients with symptomatic PAD should receive the same secondary prevention management as patients with symptomatic coronary artery disease. Improving daily physical activity (PA) is particularly important in individuals with IC as lower PA levels have been recognised as a strong predictor of increased morbidity and mortality in this population. Current National Institute for Health and Care Excellence (NICE) guidelines recommend the use of supervised exercise programmes (SEPs), encouraging patients "to exercise to the point of maximal pain", as first line treatment. SEPs has been shown to be cost-effective when compared to other treatment options such as endovascular intervention and surgical revascularisation. However, while systematic reviews show that SEPs lead to a significant improvement in the absolute walking distances of patients with IC on a treadmill, it is unclear if this is sustained or leads to improvement in daily PA. Furthermore, due to the considerable extra resources required to deliver the recommended 3 months exercise programme (30-45 minutes 3x weekly), SEPs are not always routinely available to National Health Service (NHS) patients, and time and travel costs tend to lead to low patient uptake and high attrition rates. Therefore, investigating the feasibility of using low-cost, patient-centred interventions that can support increased PA is warranted.

Lack of self-efficacy, attributed to poor understanding of the disease and uncertainty regarding the importance of exercise, has been shown to be a major barrier to exercise uptake in this population. Educating patients with IC about their disease pathology and the benefits of walking is key to enhancing success of secondary prevention strategies for people with IC. Investigators recently piloted a structured, patient-centred education intervention (SEDRIC) with the specific aim of educating patients with IC about their condition, improving patient ownership, and promoting self-managed walking. In addition to improved treadmill walking distances, investigators found out that there was a trend for patients to increase their daily PA.

For patients with IC to gain benefits of secondary prevention, exercising beyond the point when pain occurs is recommended, representing another barrier to engagement in PA. Despite this, investigators' systematic review found that pain management as a route to facilitate exercise and PA has rarely been explored. Recent interest has focused on the use of TENS (a low-cost, non-invasive pain management device) to improve angiogenesis, muscle function, pain and walking distances in patients with IC. TENS has a strong placebo effect in pain conditions, and testing effectiveness against placebo is advocated. In a proof-of-concept pilot study, Investigators demonstrated that TENS could significantly improve pain and increase treadmill walking distances above placebo levels. Our exploratory study also established that home use of TENS was both acceptable and provided self-reported improvement in PA in individuals with IC.

Although patient-centred education (SEDRIC) and TENS have both demonstrated potential to improve daily PA in people with IC, the use of these components in combination has not previously been evaluated. Investigators therefore propose a 2 x 2 (TENS versus placebo TENS x SEDRIC versus no additional education) feasibility Randomised Controlled Trial (RCT) that will compare use of TENS against placebo TENS with and without a patient-centred education programme.

Investigators have conducted a series of pilot studies underpinning both aspects of the intervention. Investigators have demonstrated in an experimental lower limb ischaemic pain model in healthy volunteers (n=28) that TENS significantly reduced onset of pain (by 29 seconds; 23%), tolerance of pain (by 203 seconds; 53%) and the pain endurance (by 173 seconds; 67%), compared to placebo TENS. Following this, in a proof-of-concept pilot study, investigators demonstrated that TENS when applied to patient with IC exercising on a treadmill (n=40) significantly improved absolute claudication distance (ACD) above placebo levels (approx. mean individual increase in ACD of 40%, p=.025, r= .53). Our phase 2 study also established that home use of TENS was both acceptable and provided self-reported improvement in PA in individuals with IC. Investigators have not assessed the ability of TENS to improve ACD when used during daily life.

Similarly, this research group developed and piloted SEDRIC, a structured, patient-centred education intervention with the specific aim of educating patients about their condition, improving patient ownership, and promoting self-managed walking. Investigators found that in patients with PAD (n=14), treadmill walking distances (30%) and quality of life (32%) improved from baseline after 6 weeks of structured education, and there was a trend for patients to increase their daily PA (approx. 8% change from baseline).

The aim is to determine the feasibility of electrical stimulation via a low-cost CE-marked device used within a patient centred education programme to improve walking distances in patients with PAD.

The following research questions will be answered by this project:

  1. What is the feasibility (i.e. recruitment and retention rates, adherence, safety, sample size for a definitive trial, potential for effectiveness) of conducting a definitive RCT comparing TENS with and without patient-centred education?
  2. How acceptable are TENS and patient-centred education as interventions on their own or in combination in patients with IC?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Strathcylde
      • Glasgow, Strathcylde, United Kingdom, G51 4TF
        • Clinical Research Facility, Queen Elizabeth University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active TENS
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Device: Active TENS
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.
Other Names:
  • TENS
  • TNS
  • Transcutaneous Electrical Nerve Stimulation
  • Transcutaneous Nerve Stimulation
Placebo Comparator: Placebo TENS
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Device: Placebo TENS
TENS device use with setting so that the stimulation delivered is ineffective
Other Names:
  • P-TENS
  • Placebo Transcutaneous Electrical Nerve Stimulation
Experimental: Patient-Centred Education
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Behavioral: Patient-Centred Education
Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Other Names:
  • Education
  • SEDRIC
  • Structured patient-centred education intervention
Experimental: Patient-Centred Education + Active TENS
Combination of Patient-Centred Education arm and Active TENS arm.
Device: Active TENS
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.
Other Names:
  • TENS
  • TNS
  • Transcutaneous Electrical Nerve Stimulation
  • Transcutaneous Nerve Stimulation
Behavioral: Patient-Centred Education
Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Other Names:
  • Education
  • SEDRIC
  • Structured patient-centred education intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Absolute Claudication Distance (ACD) in Meters From Baseline
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Maximal walking distance on graded treadmill test
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Recruitment Rates
Time Frame: Recruitment
Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Recruitment
Participant Retention Rate
Time Frame: End of study (18 weeks)
Ratio of patients who completed the intervention and outcome assessment to the patient who consented
End of study (18 weeks)
Adverse Events
Time Frame: End of study (18 weeks)
Record defined adverse events in all groups
End of study (18 weeks)
Uptake of Interventions
Time Frame: End of study (18 weeks)
Measure uptake of intervention via log of TENS use and attendance at education session and follow up phone calls
End of study (18 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Initial Claudication Distance (ICD) in Meters From Baseline
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Onset distance of claudication pain on graded treadmill test
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Change in Daily Number of Steps
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Change in daily number of steps (activpal step counts)
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Change in Total Number of Upright Events Per Day
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Total number of upright events per day (activpal upright even count)
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Change in Total Number of Walking Events Per Day
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Total number of walking events per day (activpal walking event counts)
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Change in Event-based Claudication Index
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Event-based claudication index (ratio of walking events to upright events) participants undertake in a day.
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Intermittent Claudication Questionnaire (ICQ)
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Disease specific quality of life questionnaire. ICQ scores range from 0 to 100, with lower scores representing better health status and less impact of claudication
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Short-Form 36 Questionnaire- Physical Component
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Generic quality of life questionnaire, physical domain. The SF-36 Physical Component Summary (PCS) ranges from 0-100, with higher scores representing better outcomes.
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
McGill Pain Questionnaire (MPQ) Pain Rating Index (PRI)
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Pain quality questionnaire. The MPQ-PRI ranges from 0-78, with lower scores representing less pain and higher scores representing worse pain.
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Visual Analogue Scale (VAS)
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Average Pain intensity in the past 7 days. The average pain intensity VAS ranges from 0-100 mm, with lower scores indicating less pain and better outcomes.
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Brief Illness Perception Questionnaire (IPQ)
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
The Brief IPQ uses 0-10 scales. Higher scores indicate worse perceptions (greater perceived consequences, concern, emotional impact, chronicity).
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Geriatric Depression Scale (Short Form) (GDS-SF)
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Depression questionnaire. The GDS-SF ranges 0-15, with higher scores reflecting more depressive symptoms.
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
The PSEQ total score ranges from 0-60, with higher scores indicating better pain self-efficacy and more positive outcomes.
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
SF-36 Mental Component Score
Time Frame: Baseline, end of intervention and follow-up
SF-36 Quality of life scale - mental component. The SF-36 MCS ranges 0-100 (or norm-based mean 50, SD 10), with higher scores representing better outcomes.
Baseline, end of intervention and follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glasgow Caledonian University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northumbria University
NHS Greater Glasgow and Clyde
University of Glasgow
Chief Scientist Office of the Scottish Government

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chris Seenan, PT, PhD, Glasgow Caledonian University
  • Principal Investigator: UKACHUKWU ABARAOGU, MSc, PT, Glasgow Caledonian University
  • Study Chair: Julie Brittenden, MD, FRCS, Queen Elizabeth University Hospital/University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16 044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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