Actively Recruiting
Feasibility of Developing Personalised Treatment Pathways for Relief of Plantar Heel Pain Using a Sequential Multiple Assignment Randomised Trial (SMART) Design
Led by Cardiff and Vale University Health Board · Updated on 2025-05-13
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the best ways to treat heel pain caused by plantar fasciitis through a feasibility study that tests different treatment combinations and study methods. This study aims to prepare for a larger future trial by evaluating whether the research design is practical, if enough people can be recruited, and if the treatments and procedures are acceptable to both patients and healthcare staff. Participants will be randomly assigned to begin with either a virtual consultation with a podiatrist or a self-help video, both providing advice on managing heel pain. After at least four weeks of following this initial advice, those who still have pain will be reassessed and randomly assigned to receive either orthotic devices (shoe insoles) or a course of Shockwave therapy, which uses ultrasound pulses to stimulate healing. These treatment pathways are standard NHS practices, and no experimental devices or techniques will be used. During the six months of participation, individuals will complete questionnaires and keep a diary about their heel pain. Some participants might also join interviews or group discussions to share their experiences. Researchers will monitor recruitment success, treatment adherence, patient and staff acceptance, and retention rates. The study aims to inform whether a full-scale trial can be conducted to test the effectiveness of personalized treatment pathways for heel pain.
CONDITIONS
Brief Title
HeEL Pain Pathways Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or over
- Have symptomatic heel pain (in one or both feet)
- Able to speak, read and understand written and spoken English or Welsh
- Able to provide remote informed consent
- Access to internet and email, or DVD player, with technical support from family, friends or carers if necessary.
You will not qualify if you...
- Taken part in a prescribed exercise intervention or used prescribed insoles in the past 3 months
- History of major trauma or fracture of the lower leg or below ankle surgery
- Heel pain secondary to a systemic condition, syndrome, or malignancy
- Requires ankle-foot orthoses or lower limb device (splint)
- Diabetes or peripheral neuropathy
- History of inflammatory joint disease or autoimmune condition
- Chronic pain syndrome
- Pregnancy
- Pacemaker or other electrical implant
- Blood clotting disorder (haemophilia), blood clot (thrombosis), or current use of anticoagulant medication
- Cortisone injection therapy within the last two weeks
- Unable to complete exercises in self-help resources.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - At least 4 weeks
Participants receive initial treatment either through a virtual consultation with a podiatrist or by watching a self-help video. Both provide self-management advice including footwear, massage, and stretching guidance.
1 virtual consultation visit or self-managed at home with video
Duration - Up to 3 weeks for Shockwave therapy or ongoing use of orthotic devices during recovery
Participants who have not responded to initial treatment receive an in-person musculoskeletal assessment by a podiatrist followed by either orthotic device fitting or a course of Shockwave therapy.
1 assessment visit plus either approximately 3 weekly Shockwave therapy visits or orthotic fitting visit
Duration - 6 months
Participants complete patient-reported outcome measures and share their experiences of the adaptive treatment pathways over a total duration of 6 months.
Follow-up contacts and assessments as part of outcome measurement
Trial Site Locations
Total: 1 location
1
Podiatry Department, Cardiff Royal Infirmary
Cardiff, Wales, United Kingdom, CF24 0SZ
Actively Recruiting
Research Team
N
Nia J Jones, PhD
R
Ruth L Poole, MPhil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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