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

NCT03204825 | Completed Results DMC

• 1 other identifier: 16 044
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Keywords

Patient education; Pain management; Transcutaneous electrical nerve stimulation; Physical activity; Feasibility

Outcome Measures

Primary Outcomes (5)

• Change in Absolute Claudication Distance (ACD) in Meters From Baseline

  Maximal walking distance on graded treadmill test

  Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)

• Recruitment Rates

  Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log

  Recruitment

• Participant Retention Rate

  Ratio of patients who completed the intervention and outcome assessment to the patient who consented

  End of study (18 weeks)

• Adverse Events

  Record defined adverse events in all groups

  End of study (18 weeks)

• Uptake of Interventions

  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 Outcomes (13)

• Change in Initial Claudication Distance (ICD) in Meters From Baseline

  Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)

• Change in Daily Number of Steps

  Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)

• Change in Total Number of Upright Events Per Day

  Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)

• Change in Total Number of Walking Events Per Day

  Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)

• Change in Event-based Claudication Index

  Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)

Study Arms (4)

Active TENS

EXPERIMENTAL

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

Placebo TENS

PLACEBO COMPARATOR

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

Patient-Centred Education

EXPERIMENTAL

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

Patient-Centred Education + Active TENS

EXPERIMENTAL

Combination of Patient-Centred Education arm and Active TENS arm.

Device: Active TENS; Behavioral: Patient-Centred Education

Interventions

Active TENS DEVICE

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.

Also known as: TENS, TNS, Transcutaneous Nerve Stimulation, Transcutaneous Electrical Nerve Stimulation

Active TENS; Patient-Centred Education + Active TENS

Patient-Centred Education BEHAVIORAL

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

Also known as: Education, SEDRIC, Structured patient-centred education intervention

Patient-Centred Education; Patient-Centred Education + Active TENS

Placebo TENS DEVICE

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

Also known as: P-TENS, Placebo Transcutaneous Electrical Nerve Stimulation

Placebo TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• NHS Greater Glasgow and Clyde: collaborator
• University of Glasgow: collaborator
• Northumbria University: collaborator
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (1)

Clinical Research Facility, Queen Elizabeth University Hospital

Glasgow, Strathcylde, G51 4TF, United Kingdom

Location

Related Publications (7)

• Abaraogu UO, Dall PM, Seenan CA. Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. BMJ Open. 2016 May 20;6(5):e011405. doi: 10.1136/bmjopen-2016-011405.

  PMID: 27207628 BACKGROUND

• Tew GA, Humphreys L, Crank H, Hewitt C, Nawaz S, Al-Jundi W, Trender H, Michaels J, Gorely T. The development and pilot randomised controlled trial of a group education programme for promoting walking in people with intermittent claudication. Vasc Med. 2015 Aug;20(4):348-57. doi: 10.1177/1358863X15577857. Epub 2015 Apr 9.

  PMID: 25858012 BACKGROUND

• Abaraogu UO, Ezenwankwo EF, Dall PM, Seenan CA. Living a burdensome and demanding life: A qualitative systematic review of the patients experiences of peripheral arterial disease. PLoS One. 2018 Nov 15;13(11):e0207456. doi: 10.1371/journal.pone.0207456. eCollection 2018.

  PMID: 30440040 BACKGROUND

• Abaraogu U, Ezenwankwo E, Dall P, Tew G, Stuart W, Brittenden J, Seenan C. Barriers and enablers to walking in individuals with intermittent claudication: A systematic review to conceptualize a relevant and patient-centered program. PLoS One. 2018 Jul 26;13(7):e0201095. doi: 10.1371/journal.pone.0201095. eCollection 2018.

  PMID: 30048501 BACKGROUND

• Abaraogu UO, Dall PM, Seenan CA. The Effect of Structured Patient Education on Physical Activity in Patients with Peripheral Arterial Disease and Intermittent Claudication: A Systematic Review. Eur J Vasc Endovasc Surg. 2017 Jul;54(1):58-68. doi: 10.1016/j.ejvs.2017.04.003. Epub 2017 May 18.

  PMID: 28528678 BACKGROUND

• Seenan C, Abaraogu U, Dall PM, Gilmour L, Tew G, Stuart W, Elders A, Brittenden J. Pain management and patient education interventions to increase physical activity in people with intermittent claudication (PrEPAID): a feasibility randomised controlled trial in the UK. BMJ Open. 2025 Jul 22;15(7):e105563. doi: 10.1136/bmjopen-2025-105563.

  PMID: 40701603 DERIVED

• Abaraogu UO, Dall PM, Brittenden J, Stuart W, Tew GA, Godwin J, Seenan CA. Efficacy and Feasibility of Pain management and Patient Education for Physical Activity in Intermittent claudication (PrEPAID): protocol for a randomised controlled trial. Trials. 2019 Apr 16;20(1):222. doi: 10.1186/s13063-019-3307-6.

  PMID: 30992033 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Agnosia; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation; Educational Status

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr Chris Seenan
• Organization: University of Stirling

christopher.seenan@stir.ac.uk

+441413318151

Study Officials

• Chris Seenan, PT, PhD

  Glasgow Caledonian University

  STUDY DIRECTOR

• UKACHUKWU ABARAOGU, MSc, PT

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

• Julie Brittenden, MD, FRCS

  Queen Elizabeth University Hospital/University of Glasgow

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Primary outcome assessors will be blinded for patient group allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 randomised feasibility controlled trial blinded for primary outcome

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)