N/A
N=56
Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID)
Peripheral Arterial Disease · Intermittent Claudication
Bottom Line
View on ClinicalTrials.gov: NCT03204825 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in Absolute Claudication Distance (ACD) in Meters From Baseline — -16.8; -6.7; 76.2; -0.9 metres
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active TENS (Device); Patient-Centred Education (Behavioral); Placebo TENS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Glasgow Caledonian University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Absolute Claudication Distance (ACD) in Meters From Baseline |
-16.8; -6.7; 76.2; -0.9; 25.0; -17.6 | — |
| PRIMARY Recruitment Rates |
95 | — |
| PRIMARY Participant Retention Rate |
13; 10; 12; 10 | — |
| PRIMARY Adverse Events |
1; 0; 0; 0 | — |
| PRIMARY Uptake of Interventions |
39; 27; 18 | — |
| SECONDARY Change in Initial Claudication Distance (ICD) in Meters From Baseline |
37.8; 23.2; 107.6; 52.2; 55.2; 77.1 | — |
| SECONDARY Change in Daily Number of Steps |
-1568; -237; 1076; 442; -1942; -183 | — |
| SECONDARY Change in Total Number of Upright Events Per Day |
-1.1; -2.3; -3.9; 1.7; -2.1; 2.5 | — |
| SECONDARY Change in Total Number of Walking Events Per Day |
-27.7; -22.1; -27.6; 16.3; -53.5; 0.1 | — |
| SECONDARY Change in Event-based Claudication Index |
-0.4; -0.4; 0.9; -0.2; -1.2; -0.7 | — |
| SECONDARY Intermittent Claudication Questionnaire (ICQ) |
4.5; 5.6; 8.5; 9.6; 4.4; 2.3 | — |
| SECONDARY Short-Form 36 Questionnaire- Physical Component |
1.4; 0.0; -5.2; -4.5; -0.6; 1.0 | — |
| SECONDARY McGill Pain Questionnaire (MPQ) Pain Rating Index (PRI) |
4.3; 3.5; -5.9; -6.5; 2.5; 2.6 | — |
| SECONDARY Visual Analogue Scale (VAS) |
-0.7; -1.0; -2.0; -1.5; -1.2; -1.4 | — |
| SECONDARY Brief Illness Perception Questionnaire (IPQ) |
-1.7; 0.6; -7.7; -8.1; -1.5; 1.0 | — |
| SECONDARY Geriatric Depression Scale (Short Form) (GDS-SF) |
-1.5; -0.8; -1.8; -1.2; -0.9; 0.2 | — |
| SECONDARY Pain Self-Efficacy Questionnaire (PSEQ) |
1.0; 0.8; 5.2; 6.9; 1.9; 0.4 | — |
| SECONDARY SF-36 Mental Component Score |
-2.8; 0.5; -3.0; -1.8; -0.1; 0.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting Ankle Brachial Pressure Index (ABPI) 20% variation in baseline ACD on treadmill
- Severe peripheral neuropathies above the ankle.
- Participation in another research protocol
Data sourced from ClinicalTrials.gov (NCT03204825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.