Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID) (PrEPAID)
Peripheral Arterial Disease, Intermittent Claudication
About this trial
This is an interventional other trial for Peripheral Arterial Disease focused on measuring Patient education, Pain management, Transcutaneous electrical nerve stimulation, Physical activity, Feasibility
Eligibility Criteria
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
Sites / Locations
- Clinical Research Facility, Queen Elizabeth University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Active TENS
Placebo TENS
Patient-Centred Education
Patient-Centred Education + 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'').
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.
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.
Combination of Patient-Centred Education arm and Active TENS arm.