Plantar FasciitisHELPPNCT06967168
HeEL Pain Pathways Feasibility Study
A study testing Virtual consultation, Self-help video and Orthotics in people with Plantar Fasciitis, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
At the moment, no-one is sure what the best way to treat heel pain is. The purpose of this research was 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Virtual consultation, Self-help video and Orthotics
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2024to 24 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Podiatry Department, Cardiff Royal Infirmary
Cardiff, Wales, CF24 0SZ
About this 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
At the moment, no-one is sure what the best way to treat heel pain is. The purpose of this research was 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 was only to test the study processes and ask for feedback - that is why this is called a feasibility study. No experimental techniques or devices were tested. All of the treatments in the study are routinely carried out in NHS clinics, but participants were allocated to different combinations of treatments.
Each participant was asked to complete questionnaires and a diary for around six months in total. Some people were also invited to take part in an interview or focus group discussion.
Read the detailed description
This single-centre study tested the feasibility of using a SMART design to provide tailored treatment pathways for people with heel pain. The study investigated areas of uncertainty relating to the feasibility of a future full-scale SMART study. Key objectives were 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.
32 people with heel pain were recruited from referrals to the Podiatry department and from a self-referral route. Participants were randomly assigned to two groups initially - half had a virtual consultation with a podiatrist; the other half received a self-help video. After following the advice at home for at least 4 weeks, anyone (in either group) who had not responded to treatment was offered an assessment in an outpatient clinic. They were then 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) were used to talk to patients. They were asked about their experiences of adaptive intervention pathways and of participating in the feasibility study. The researchers also interviewed staff involved in trial design and delivery (clinical members of the study delivery team) about similar topics from a different perspective. Progression criteria were used to help decide whether to continue with the plan to run a full-scale trial to test effectiveness of the treatment pathways.
- Conditions
- Plantar Fasciitis
- Being tested
- Virtual consultation, Self-help video, Orthotics, Shockwave therapy
- Keywords
- pain management, podiatry, musculoskeletal diseases, foot diseases, foot orthoses, extracorporeal shockwave therapy, conservative treatment, self care
- Medical subject headings
- Fasciitis, Plantar, Agnosia, Musculoskeletal Diseases, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual consultationBehavioural
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 videoBehavioural
Self-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
OrthoticsDevice
Also called Shoe inserts
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 therapyDevice
Also called ESWT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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). Receives: Behavioral: Self-help video; Device: Shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment (Progression Criterion 1)
Average number of participants per month. Stop if <2; Change if 2-6; Go if >6.
Measured: 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%.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start27 Sep 2024
- Primary completion24 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Sequential Multiple Assignment Randomised Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nia J Jones, PhD, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967168
- Sponsor's protocol ID
- 8651
- Other IDs
- RfPPB-22-1937 - Dr Nia Jones
- Acronym
- HELPP
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The small outcome groups and qualitative nature of the data mean there is a risk of statistical disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Developing Personalised Treatment Pathways for Relief of Plantar Heel Pain Using a Sequential Multiple Assignment Randomised Trial (SMART) Study Design
- ClinicalTrials.gov ID
- NCT06967168
- Acronym / sponsor ID
- HELPP / 8651
- Conditions
- Plantar Fasciitis
- Keywords
- pain management, podiatry, musculoskeletal diseases, foot diseases, foot orthoses, extracorporeal shockwave therapy, conservative treatment, self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the moment, no-one is sure what the best way to treat heel pain is. The purpose of this research was 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 was only to test the study processes and ask for feedback - that is why this is called a feasibility study. No experimental techniques or devices were tested. All of the treatments in the study are routinely carried out in NHS clinics, but participants were allocated to different combinations of treatments.
Each participant was asked to complete questionnaires and a diary for around six months in total. Some people were also invited to take part in an interview or focus group discussion.
Detailed description
This single-centre study tested the feasibility of using a SMART design to provide tailored treatment pathways for people with heel pain. The study investigated areas of uncertainty relating to the feasibility of a future full-scale SMART study. Key objectives were 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.
32 people with heel pain were recruited from referrals to the Podiatry department and from a self-referral route. Participants were randomly assigned to two groups initially - half had a virtual consultation with a podiatrist; the other half received a self-help video. After following the advice at home for at least 4 weeks, anyone (in either group) who had not responded to treatment was offered an assessment in an outpatient clinic. They were then 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) were used to talk to patients. They were asked about their experiences of adaptive intervention pathways and of participating in the feasibility study. The researchers also interviewed staff involved in trial design and delivery (clinical members of the study delivery team) about similar topics from a different perspective. Progression criteria were used to help decide whether to continue with the plan to run a full-scale trial to test effectiveness of the treatment pathways.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Sequential Multiple Assignment Randomised Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Adaptive Intervention 1 (outcome subgroups A+B) | Active comparator | Behavioral: Virtual consultation, Device: OrthoticsFirst-line treatment: Virtual consultation. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Orthotics. |
| Adaptive Intervention 2 (outcome subgroups A+C) | Active comparator | Behavioral: Virtual consultation, Device: Shockwave therapyFirst-line treatment: Virtual consultation. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Shockwave therapy (ESWT). |
| Adaptive Intervention 3 (outcome subgroups D+E) | Active comparator | Behavioral: Self-help video, Device: OrthoticsFirst-line treatment: Self-help video. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Orthotics. |
| Adaptive Intervention 4 (outcome subgroups D+F) | Active comparator | Behavioral: Self-help video, Device: Shockwave therapyFirst-line treatment: Self-help video. Those whose pain is not resolved after 4 weeks will progress onto second-line treatment: Shockwave therapy (ESWT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual consultationVirtual (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. | Behavioural | Adaptive Intervention 1 (outcome subgroups A+B), Adaptive Intervention 2 (outcome subgroups A+C) |
| Self-help videoSelf-help video providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD. | Behavioural | Adaptive Intervention 3 (outcome subgroups D+E), Adaptive Intervention 4 (outcome subgroups D+F) |
| OrthoticsAlso: Shoe insertsProvision 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. | Device | Adaptive Intervention 1 (outcome subgroups A+B), Adaptive Intervention 3 (outcome subgroups D+E) |
| Shockwave therapyAlso: ESWTA 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. | Device | Adaptive Intervention 2 (outcome subgroups A+C), Adaptive Intervention 4 (outcome subgroups D+F) |
Primary outcome
Feasibility of recruitment (Progression Criterion 1)
Time frame: Through study completion, an average of 1 year.
Average number of participants per month. Stop if <2; Change if 2-6; Go if >6.
Fidelity of clinical delivery of the correct treatment at the correct stage (Progression Criterion 2)
Time frame: Through study completion, an average of 1 year.
Proportion of participants who receive the treatments they are allocated to after each randomisation. Stop if <50%; Change if 50-80%; Go if >80%.
Appropriateness of tailoring criteria and its threshold (Progression Criterion 3)
Time frame: Through study completion, an average of 1 year.
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.
Rate of retention/loss to follow-up, including withdrawals (Progression Criterion 4)
Time frame: Through study completion, an average of 1 year.
Proportion of participants who fail to complete the study. Stop if >50%; Change if 20-50%; Go if <20%.
Acceptability of adaptive intervention pathways amongst patients
Time frame: Through study completion, an average of 1 year.
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.
Acceptability of adaptive intervention pathways amongst staff
Time frame: Through study completion, an average of 1 year.
Qualitative interviews will be carried out with study staff to determine acceptability of adaptive interventions, including barriers and facilitators to delivering the SMART study.
1 secondary outcome
Estimated effect size and variance
Time frame: Baseline and Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Summary of the HELPP studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The small outcome groups and qualitative nature of the data mean there is a risk of statistical disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nia J Jones, PhD principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual consultation, Self-help video and Orthotics in people with Plantar Fasciitis, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (Progression Criterion 1) (time frame: Through study completion, an average of 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.