Clinical trial NCT06967168: HeEL Pain Pathways Feasibility Study
Official title: Feasibility of Developing Personalised Treatment Pathways for Relief of Plantar Heel Pain Using a Sequential Multiple Assignment Randomised Trial (SMART) Study Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fasciitis
Keywords: pain management
podiatry
musculoskeletal diseases
foot diseases
foot orthoses
extracorporeal shockwave therapy
conservative treatment
self care
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2025-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Sequential Multiple Assignment Randomised Trial (SMART)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This single-centre study will test the feasibility of using a SMART design to provide tailored treatment pathways for people with heel pain. The study will investigate areas of uncertainty relating to the feasibility of a future full-scale SMART study. Key objectives are to assess whether the research design is feasible (including whether enough people can be recruited), and to determine whether the proposed adaptive intervention pathways are acceptable to patients and NHS staff.

50 people with heel pain will be recruited from referrals received by the Podiatry department. Participants will be randomly assigned to two groups initially - half will have a virtual consultation with a podiatrist; the other half will receive a self-help video. After following the advice at home for at least 4 weeks, anyone (in either group) who has not responded to treatment will be offered an assessment in an outpatient clinic. They will then be randomised equally again to receive either an orthotic device (shoe insole) or a course of 'Shockwave therapy' (using a non-invasive device to deliver ultrasound to the injured area).

As well as collecting Patient Reported Outcome Measures (PROMs) for a total duration of 6 months for each participant, process evaluation methods (interviews and focus groups) will be used to talk to patients. They will be asked about their experiences of adaptive intervention pathways and of participating in the feasibility study. The researchers will also interview staff involved in trial design and delivery (clinical members of the study delivery team) about similar topics from a different perspective. Progression criteria will be used to help decide whether to continue with the plan to run a full-scale trial to test effectiveness of the treatment pathways.

Eligibility 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.

Primary outcomes:
measure: Feasibility of recruitment (Progression Criterion 1)
timeFrame: Through study completion, an average of 1 year.
measure: Fidelity of clinical delivery of the correct treatment at the correct stage (Progression Criterion 2)
timeFrame: Through study completion, an average of 1 year.
measure: Appropriateness of tailoring criteria and its threshold (Progression Criterion 3)
timeFrame: Through study completion, an average of 1 year.
measure: Rate of retention/loss to follow-up, including withdrawals (Progression Criterion 4)
timeFrame: Through study completion, an average of 1 year.
measure: Acceptability of adaptive intervention pathways amongst patients
timeFrame: Through study completion, an average of 1 year.
measure: Acceptability of adaptive intervention pathways amongst staff
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Estimated effect size and variance
timeFrame: Baseline and Week 26
Other outcomes:
measure: Acceptability of data collection tools (quantitative)
timeFrame: Through study completion, an average of 1 year.
measure: Acceptability of data collection tools (qualitative)
timeFrame: Through study completion, an average of 1 year.
measure: Feasibility of collecting health service resource use data (staff time)
timeFrame: Through study completion, an average of 1 year.
measure: Feasibility of collecting health service resource use data (equipment)
timeFrame: Through study completion, an average of 1 year.
measure: Feasibility of collecting health service resource use data (number of appointments)
timeFrame: Through study completion, an average of 1 year.
measure: Feasibility of collecting health service resource use data (type of appointment)
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Cardiff
country: United Kingdom
facility: Podiatry Department, Cardiff Royal Infirmary
state: Wales
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Nia J Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: