PAIN MANAGEMENT AND PATIENT EDUCATION IN INTERMITTENT CLAUDICATION
Research type
Research Study
Full title
PAIN MANAGEMENT AND PATIENT EDUCATION FOR PHYSICAL ACTIVITY IN INTERMITTENT CLAUDICATION (PREPAID): FEASIBILITY RANDOMISED CONTROLLED TRIAL
IRAS ID
222460
Contact name
Ukachukwu O Abaraogu
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Summary of Research
Patients with Peripheral arterial diseases (PAD), commonly experience pain in the buttock, thigh or calf on walking which is relieved by rest. This is caused by narrowing of the arteries, caused by fatty deposits, which lead to inadequate blood flow during exercise resulting in the build-up of lactic acid in the muscles. Patients are advised to exercise regularly and increase their physical activity (PA), but this is often limited due to pain. We have previously shown that the use of a Transcutaneous Electrical Nerve Stimulation (TENS) machine leads to a reduction in pain and increases the walking distance. Evidence also suggests that educating patients about their condition and helping them to set PA goals with feedback, has the potential to increase PA. This study will determine if the TENS machine can improve the physical activity of patients with PAD when delivered alone and/or within a patient centred education programme.
Summary of Report
Feasibility of recruiting participants, adherence and collecting outcome measures The study team reviewed the medical records of 1030 people with PAD and IC, and the 267 people who met the inclusion criteria were invited to participate. Of those, 95 individuals with PAD and IC attended for eligibility screening, including treadmill walking assessment. Although we screened 95 people for eligibility, the study did not meet the target of 80 participants for randomisation. This was because many people (n=38) had a greater than 20% variability in maximal treadmill walking distance, the primary outcome measure and an exclusion criteria.
The 56 participants who were randomised all received their allocated intervention (42 (75%) male, mean age 66 years).Retention and outcome measure completion:
91% of participants (n=51) completed outcome measures at end of intervention and 80% at 3-month follow-up (n=45). The data collected was of good quality for all outcome measures. These data indicate that the trial procedures and design of the interventions are largely successful. Participants were willing to participate and kept returning for the assessment visits.Adverse events:
Three participants reported ‘Itching’ as a defined adverse event related to use of TENS. No other adverse events were reported throughout the study indicating that the interventions and testing procedures are generally safe for this group of participants.Uptake of interventions:
Participant compliance with TENS use (30 mins per day 3 times per week for at least 3 weeks) was 70% according to participant completed logbooks but only 28% according to objective record of the TENS machines. Although the TENS machine internal log objectively measured use, problems with batteries and study procedures meant that there were fewer of these records. The discrepancy between participant-reported and objective rates of adherence with TENS may indicate social desirability bias in reporting but may also be an artefact of the issues with collecting objective data from the devices. Attendance at the group education session was 96% and overall compliance with intervention was 63% (attendance at the session, and answering to at least one of the 2-weekly phone calls). Education sessions were very well-attended and the drop-off in adherence to the follow-up phone calls could be addressed by agreeing the timing of the phone calls with the participants, rather than the ad hoc approach used in the study.Acceptability of interventions:
Eighteen participants agreed to be interviewed about their experience of the study and interventions. Nine completed the interviews and were generally positive about the interventions and the trial procedures. The quotes below are representative examples of the participant responses.REC name
West of Scotland REC 4
REC reference
17/WS/0094
Date of REC Opinion
17 May 2017
REC opinion
Favourable Opinion