HeEL Pain Pathways Feasibility Study
ConditionPlantar Fasciitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiff and Vale University Health Board
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Factorial
Treatments tested in this trial
Virtual consultation
BehavioralVirtual (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
BehavioralSelf-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
Orthotics
DeviceProvision 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.
Shockwave therapy
DeviceA 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.
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Adaptive Intervention 1 (outcome subgroups A+B)Active comparator 2 interventions
Group B: Adaptive Intervention 2 (outcome subgroups A+C)Active comparator 2 interventions
Group C: Adaptive Intervention 3 (outcome subgroups D+E)Active comparator 2 interventions
Group D: Adaptive Intervention 4 (outcome subgroups D+F)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Feasibility of recruitment (Progression Criterion 1)
Average number of participants per month. Stop if \<2; Change if 2-6; Go if \>6.
Time frame
Through study completion, an average of 1 year.2
Fidelity of clinical delivery of the correct treatment at the correct stage (Progression Criterion 2)
Proportion of participants who receive the treatments they are allocated to after each randomisation. Stop if \<50%; Change if 50-80%; Go if \>80%.
Time frame
Through study completion, an average of 1 year.3
Appropriateness of tailoring criteria and its threshold (Progression Criterion 3)
Minimum number of participants in any of the SMART outcome subgroups (A-F) at the end of the study. Stop if \<1; Change if 1-4; Go if \>4.
Time frame
Through study completion, an average of 1 year.4
Rate of retention/loss to follow-up, including withdrawals (Progression Criterion 4)
Proportion of participants who fail to complete the study. Stop if \>50%; Change if 20-50%; Go if \<20%.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
Estimated effect size and variance
Composite outcome data from validated PROM - Revised Foot Function Index (short)
Time frame
Baseline and Week 26Other outcomes
1
Acceptability of data collection tools (quantitative)
Completeness of PROM questionnaires and participant diaries/records.
Time frame
Through study completion, an average of 1 year.2
Acceptability of data collection tools (qualitative)
Qualitative information from staff and participant interviews/focus groups.
Time frame
Through study completion, an average of 1 year.3
Feasibility of collecting health service resource use data (staff time)
Any deviations from the usual amount of staff time required will be reported in narrative form by the delivery team.
Time frame
Through study completion, an average of 1 year.4
Feasibility of collecting health service resource use data (equipment)
Any deviations from standard care with respect to the equipment required will be reported in narrative form by the delivery team.
Time frame
Through study completion, an average of 1 year.Sponsors and contacts
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Source ClinicalTrials.gov