Testing treatment options for heel pain
Feasibility of Developing Personalised Treatment Pathways for Relief of Plantar Heel Pain Using a Sequential Multiple Assignment Randomised Trial (SMART) Study Design
This study is testing different ways to treat heel pain from plantar fasciitis to see which methods work best for people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiff and Vale University Health Board Government |
| Locations | 1 site (Cardiff, Wales) |
| Trial ID | NCT06967168 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to explore the best methods for treating plantar fasciitis by testing different treatment combinations. Participants will be randomly assigned to receive either a virtual consultation with a podiatrist or a self-help video, followed by additional treatment options if necessary. The study will collect feedback through questionnaires, diaries, and interviews to assess the feasibility of a larger clinical trial in the future. The focus is on understanding patient experiences and the acceptability of the proposed treatment pathways.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with symptomatic heel pain who can provide informed consent and have access to the necessary technology.
Not a fit: Patients with certain medical conditions, such as diabetes, chronic pain syndromes, or those who have recently undergone specific treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from heel pain.
How similar studies have performed: While this approach is focused on feasibility, similar studies have shown promise in exploring adaptive treatment pathways for musculoskeletal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Taken part in a prescribed exercise intervention or used prescribed insoles (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/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.
Where this trial is running
Cardiff, Wales
- Podiatry Department, Cardiff Royal Infirmary — Cardiff, Wales, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nia J Jones, PhD — Cardiff and Vale University Health Board
- Study coordinator: Nia J Jones, PhD
- Email: Nia.Jones16@wales.nhs.uk
- Phone: +442921844771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.