TReatments of Exercise AnD Orthotics for plaNtar heel pain: TREADON
Research type
Research Study
Full title
Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: a randomised multi-arm multi-stage (MAMS) adaptive trial
IRAS ID
314272
Contact name
Joanne Simon
Contact email
Sponsor organisation
Keele University
Duration of Study in the UK
3 years, 4 months, 31 days
Research summary
Pain under the heel (called plantar heel pain, PHP) is a common condition affecting 1 in 10 adults during their lifetime. It makes walking and completing everyday tasks, including going to work, difficult. Most patients who consult in general practice are given pain medication and advice, yet the problem often continues. In our successful pilot and feasibility trial, foot orthoses and exercises showed promise for improving pain and function, but a large, high-quality main trial is needed to confirm this.
The aim of the TREADON trial is to show whether exercises and/or foot orthoses (shoe insoles) provide more pain relief for adults with plantar heel pain (PHP) than a self-management advice booklet alone, and whether this is good value for money.
Up to 696 adults, 18 years and over, with Plantar Heel Pain (PHP) will be recruited to this trial. Participants will be randomly allocated to receive one of the following four treatments: 1) Self-management advice (SMA) booklet only (control arm), 2) SMA booklet plus individualised exercises, 3) SMA booklet plus prefabricated foot orthoses, 4) SMA booklet plus individualised exercises and prefabricated foot orthoses.
Patients will be involved in the trial for a duration of 12 months follow up. During this period, all participants will be sent a weekly text-message/ phone call to collect pain scores for up to 12 weeks and then monthly from 3 to 12 months. All participants will be asked to complete a questionnaire at baseline, 3, 6 and 12 months. Half-way through the trial, only treatments that appear to be reducing pain will continue to be offered and the trial will stop recruiting any further participants into this treatment. Patients already randomised to this treatment will continue with this treatment until their participation finishes.
In addition to the text message/phone calls and questionnaire, the participants who are allocated into arms 2 to 4 will receive the trial interventions which will be delivered by site clinicians. These participants will receive up to a total of 6 sessions over 12 weeks. The first session is anticipating to be approx. 1 hour and subsequent visits will be approx. 30 minutes.REC name
West of Scotland REC 5
REC reference
22/WS/0165
Date of REC Opinion
22 Nov 2022
REC opinion
Favourable Opinion