Feasibility of personalised HeEL Pain Pathways (HELPP Study)
Research type
Research Study
Full title
Feasibility of developing personalised treatment pathways for relief of plantar heel pain using a sequential multiple assignment randomised trial (SMART) study design
IRAS ID
331876
Contact name
Rachel Norman
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
Clinicaltrials.gov Identifier
UID: 159323, Researchfish
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
The plantar fascia is a thick band of tissue in the bottom of the foot that attaches to the heel bone. Inflammation of the plantar fascia can cause heel pain. This hurts so much that it limits movement and activities. It is very common - almost 1 in 10 middle-aged or older adults have experienced plantar heel pain. Each year around 1,200 people with heel pain are referred to Cardiff and Vale University Health Board (CAVUHB); the total number of people with heel pain across Wales is likely to be many more.
Treatments for heel pain include exercise advice, shoe insoles, and shockwave (ultrasound) therapy. A patient-centred approach adapts treatments to suit individual people's needs. We want to work with patients and NHS staff to find out which treatment pathways work best. This initial feasibility study is funded by Health and Care Research Wales. It will help us to decide if a full-scale trial should go ahead.
We are actively partnering with patients and clinicians to co-produce this research. Our feasibility study uses a relatively new design that looks at whole patient pathways instead of separate treatments. We will recruit 50 people referred to CAVUHB with ongoing heel pain. They will be allocated at random to one of 4 different treatment pathways (known as adaptive interventions). All treatments are currently available in the NHS. We will collect study data from participants and staff using surveys, interviews, and focus groups, with a follow-up of 6 months.
Outcome measures include whether these personalised treatment pathways are acceptable to patients. Staff will also provide their views about tailoring the adaptive interventions. We will learn how well our study design works, and will investigate factors that affect whether we are able to recruit and retain enough study participants.
REC name
Wales REC 1
REC reference
24/WA/0061
Date of REC Opinion
17 Apr 2024
REC opinion
Further Information Favourable Opinion