Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-09-02
2025-11-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Adaptive Intervention 1 (outcome subgroups A+B)
First-line treatment: Virtual consultation. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Orthotics.
Virtual consultation
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.
Orthotics
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.
Adaptive Intervention 2 (outcome subgroups A+C)
First-line treatment: Virtual consultation. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Shockwave therapy (ESWT).
Virtual consultation
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.
Shockwave therapy
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.
Adaptive Intervention 3 (outcome subgroups D+E)
First-line treatment: Self-help video. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Orthotics.
Self-help video
Self-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
Orthotics
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.
Adaptive Intervention 4 (outcome subgroups D+F)
First-line treatment: Self-help video. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Shockwave therapy (ESWT).
Self-help video
Self-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
Shockwave therapy
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.
Interventions
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Virtual consultation
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
Self-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
Orthotics
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.
Shockwave therapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cardiff and Vale University Health Board
OTHER_GOV
Responsible Party
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Principal Investigators
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Nia J Jones, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiff and Vale University Health Board
Locations
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Podiatry Department, Cardiff Royal Infirmary
Cardiff, Wales, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RfPPB-22-1937 - Dr Nia Jones
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
8651
Identifier Type: -
Identifier Source: org_study_id
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