An interventional study of Virtual consultation and Self-help video in Plantar Fasciitis, sponsored by Cardiff and Vale University Health Board. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Cardiff and Vale University Health Board · Not applicable, Interventional, and Health services research
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.
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.
223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.
This study's enrollment of 32 is below the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.
Browse Fasciitis, Plantar studies →Cardiff and Vale University Health Board is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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 providing self-management advice to the participant including advice on footwear, massage, and stretching. Available online or as a DVD.
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
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
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year.
Estimated effect size and variance
Composite outcome data from validated PROM - Revised Foot Function Index (short)
Time frame: Baseline and Week 26
Acceptability of data collection tools (quantitative)
Completeness of PROM questionnaires and participant diaries/records.
Time frame: Through study completion, an average of 1 year.
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.
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.
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.
Feasibility of collecting health service resource use data (number of appointments)
Participants will be invited to indicate their frequency of use of healthcare services in patient diaries. Each week they will be asked how many appointments they have had.
Time frame: Through study completion, an average of 1 year.
Feasibility of collecting health service resource use data (type of appointment)
Participants be asked which type(s) of healthcare professional they have had appointments with (GP, nurse, physiotherapist, other) in weekly patient diaries.
Time frame: Through study completion, an average of 1 year.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The small outcome groups and qualitative nature of the data mean there is a risk of statistical disclosure.
Ran from Sep 2024 to primary completion in Dec 2025, 14 months.
Of 104 non-industry interventional studies with no phase under Fasciitis, Plantar, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 14 months is above that.
Counting every sponsor, half of 109 studies reached it within 11 months; a quarter within 6 and three quarters within 22.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Sep 2025 → Dec 2025 and completion Nov 2025 → Dec 2025.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Cardiff and Vale University Health Board