Plantar Heel Pain Mechanisms of Action Study Evaluation
Research type
Research Study
Full title
Plantar Heel Pain Mechanisms of Action Study Evaluation
IRAS ID
312459
Contact name
Chris Drake
Contact email
Sponsor organisation
The University of Leeds
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Plantar heel pain (PHP) is one of the most common causes of foot pain, affecting one in ten people over the age of 50. While this pain may reduce after getting up and walking around, for many people the pain remains, limiting their physical activity and impacting their quality of life. There are a number of treatments for PHP but no single treatment has been shown to be more effective than the others.
The National Institute for Health and Care Research (NIHR) has funded the TREADON trial (Treatments of exercise and orthotic devices for plantar heel pain NIHR 131638), to compare the effect of commonly used PHP treatments (interventions)- (i) self-management advice; (ii) exercises; (iii) shoe insoles; and (iv) a combination of exercises and insoles. TREADON will recruit people with PHP from England and Scotland, including sites in Yorkshire/Humber.
The PHASE study is a sub-study which will recruit 120 participants from TREADON’s Yorkshire and Humber sample. The aim of the research is to understand how the trial interventions actually work- known as the mechanism of action. This is important as the information can help us design future treatments and can be used for other conditions, helping a wide range of people.
PHASE will use a scan (MRI) of the foot, a detailed assessment of how a person walks and the strength and movement in the foot and ankle to see what the important changes are during treatment. Participants will be asked to attend two study visits at Chapel Allerton Hospital, Leeds, which will last approximately 2 hours. The first visit will be before treatment in the TREADON trial and the second visit should be 12 weeks after treatment starts.
This project is funded through a NIHR research fellowship (NIHR 302199, IRAS 314272) and sponsored by the University of Leeds. PHASE is an entirely self contained University of Leeds study. It is not an NHS based study although the Leeds BRC facilities are within an NHS site. No care or intervention is being provided in this study.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0018
Date of REC Opinion
16 Feb 2023
REC opinion
Further Information Favourable Opinion