HeEL Pain Pathways Feasibility Study
Feasibility of Developing Personalised Treatment Pathways for Relief of Plantar Heel Pain Using a Sequential Multiple Assignment Randomised Trial (SMART) Study Design
Cardiff and Vale University Health Board
50 participants
Sep 2, 2024
INTERVENTIONAL
Conditions
Summary
At the moment, no-one is sure what the best way to treat heel pain is. The purpose of this research is to try out some study methods to prepare for a future clinical trial, that will assess how helpful combining different treatments are for people with heel pain (plantar fasciitis). At this stage, the aim is only to test the study processes and ask for feedback - that is why this is called a feasibility study. No experimental techniques or devices will be tested. All of the treatments in the study are routinely carried out in NHS clinics, but participants will be allocated to different combinations of treatments. Each participant will be asked to complete questionnaires and a diary for around six months in total. Some people will also be invited to take part in an interview or focus group discussion.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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.
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Interventions
Virtual (telephone) consultation with a podiatrist, who will provide self-management advice to the participant including advice on footwear, massage, and stretching. Supplemented by written advice leaflets.
Self-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
Provision of orthotics following an in-person musculoskeletal assessment by a podiatrist to check foot function, footwear, and position of feet, ankles, knees, and hip. Podiatrists prescribe, produce, and fit orthotic devices to be worn inside footwear. The devices used in this feasibility study will be selected according to individual patient needs. All will have regulatory certification (CE mark) and will be used in accordance with the manufacturer's Instructions For Use.
A 3-week course of Shockwave therapy following an in-person musculoskeletal assessment by a podiatrist to check foot function, footwear, and position of feet, ankles, knees, and hip. Extracorporeal shockwave therapy (ESWT) is delivered by a podiatrist in an outpatient clinic. Most patients lie down during the procedure. The machine passes pulses of energy through the skin towards the injured area of the heel. This encourages the body to respond and aims to stimulate the healing process. Participants will need to attend the clinic approximately once a week for three weeks to complete the course of treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06967168