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N/A N=56 Randomized Double-blind Other

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

Peripheral Arterial Disease · Intermittent Claudication

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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