The TREADON pilot and feasibility trial (Version I)
Research type
Research Study
Full title
The TREADON (TReatments of Exercise AnD Orthotic devices for plaNtar heel pain) Pilot and Feasibility Trial
IRAS ID
180371
Contact name
Edward Roddy
Contact email
Sponsor organisation
Keele University
Duration of Study in the UK
1 years, 1 months, 16 days
Research summary
Pain under the heel (called plantar heel pain, PHP) is a relatively common condition with up to 1 in 10 adults affected at some point in their lives. PHP can restrict the ability to walk and to complete everyday tasks including work. Only four of every ten patients are referred by GPs to other NHS health professionals, such as physiotherapists or podiatrists, for treatments of adjustable shoe insoles (called prefabricated foot orthoses) and/or exercise. The reason that patients are not routinely referred for these treatments may be because evidence is lacking as to whether exercise or shoe insoles or a combination of both, are better treatment options than usual GP care. To provide an answer to this question we plan to conduct a large, NHS-based trial to test the clinical and cost-effectiveness of individualised exercise or adjustable shoe insoles delivered by physiotherapists and podiatrists compared with self-management advice for patients with PHP. To provide robust data, it is likely that this trial will involve a large number of patients and be both lengthy and costly to complete. As such, ensuring a high degree of methodological rigour is essential. Therefore, in order to help us make final decisions about the design and the number of treatments to be tested within this trial, we first need to carry out a small feasibility and pilot trial. In particular we want to test three different ways to recruit patients, determine the acceptability of the treatments to patients and assess patient’s ability to follow the treatment programmes given to them. We also need to test three different outcome measures to determine which one is best to select as the key outcome for the future main trial to reflect the patients’ goal of pain free walking.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0265
Date of REC Opinion
15 Jul 2016
REC opinion
Further Information Favourable Opinion