HeEL Pain Pathways Feasibility Study

NCT06967168 | Recruiting

• 2 other identifiers: 8651RfPPB-22-1937 - Dr Nia Jones
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

pain management; podiatry; musculoskeletal diseases; foot diseases; foot orthoses; extracorporeal shockwave therapy; conservative treatment; self care

Outcome Measures

Primary Outcomes (6)

• Feasibility of recruitment (Progression Criterion 1)

  Average number of participants per month. Stop if \<2; Change if 2-6; Go if \>6.

  Through study completion, an average of 1 year.

• 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%.

  Through study completion, an average of 1 year.

• 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.

  Through study completion, an average of 1 year.

• 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%.

  Through study completion, an average of 1 year.

• Acceptability of adaptive intervention pathways amongst patients

  Qualitative interviews and/or focus groups will be carried out with participants to determine the acceptability of adaptive interventions and the study design, including barriers and facilitators to following self-management advice.

  Through study completion, an average of 1 year.

• Acceptability of adaptive intervention pathways amongst staff

  Qualitative interviews will be carried out with study staff to determine acceptability of adaptive interventions, including barriers and facilitators to delivering the SMART study.

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• Estimated effect size and variance

  Baseline and Week 26

Other Outcomes (6)

• Acceptability of data collection tools (quantitative)

  Through study completion, an average of 1 year.

• Acceptability of data collection tools (qualitative)

  Through study completion, an average of 1 year.

• Feasibility of collecting health service resource use data (staff time)

  Through study completion, an average of 1 year.

Study Arms (4)

Adaptive Intervention 1 (outcome subgroups A+B)

ACTIVE COMPARATOR

First-line treatment: Virtual consultation. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Orthotics.

Behavioral: Virtual consultation; Device: Orthotics

Adaptive Intervention 2 (outcome subgroups A+C)

ACTIVE COMPARATOR

First-line treatment: Virtual consultation. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Shockwave therapy (ESWT).

Behavioral: Virtual consultation; Device: Shockwave therapy

Adaptive Intervention 3 (outcome subgroups D+E)

ACTIVE COMPARATOR

First-line treatment: Self-help video. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Orthotics.

Behavioral: Self-help video; Device: Orthotics

Adaptive Intervention 4 (outcome subgroups D+F)

ACTIVE COMPARATOR

First-line treatment: Self-help video. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Shockwave therapy (ESWT).

Behavioral: Self-help video; Device: Shockwave therapy

Interventions

Virtual consultation BEHAVIORAL

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.

Adaptive Intervention 1 (outcome subgroups A+B); Adaptive Intervention 2 (outcome subgroups A+C)

Self-help video BEHAVIORAL

Self-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.

Adaptive Intervention 3 (outcome subgroups D+E); Adaptive Intervention 4 (outcome subgroups D+F)

Orthotics DEVICE

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.

Also known as: Shoe inserts

Adaptive Intervention 1 (outcome subgroups A+B); Adaptive Intervention 3 (outcome subgroups D+E)

Shockwave therapy DEVICE

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.

Also known as: ESWT

Adaptive Intervention 2 (outcome subgroups A+C); Adaptive Intervention 4 (outcome subgroups D+F)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Podiatry Department, Cardiff Royal Infirmary

Cardiff, Wales, CF24 0SZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar; Agnosia; Musculoskeletal Diseases; Foot Diseases

Interventions

Braces; Foot Orthoses; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nia J Jones, PhD

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nia J Jones, PhD

CONTACT

+442921844771; Nia.Jones16@wales.nhs.uk

Ruth L Poole, MPhil

CONTACT

+442921844771; Ruth.Poole@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Sequential Multiple Assignment Randomised Trial (SMART)

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: May 13, 2025
• Study Start: September 2, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 28, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)