Plantar FascitisEASE-PNCT05071365
Early Access to Virtual Resources for the Self-management of Plantar Fasciitis
A study testing Early access to virtual resources in people with Plantar Fascitis, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
This proof of concept and feasibility study will adopt a mixed methods approach. The primary objectives will be to assess participants' acceptance and usability of a package of self-help videos for Plantar Fasciitis designed to be accessed shortly after suitable participants are referred to the podiatry service, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Early access to virtual resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2021to 4 Jul 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Diagnosis of Plantar Fasciitis by assessing podiatrist:
- Plantar medial heel pain: most noticeable with initial steps after a period of inactivity (post static dyskinesia) but also worse following prolonged weight bearing
- Pain with palpation of the proximal insertion of the plantar fascia, most commonly the medial calcaneal tubercle, the site of the plantar aponeurosis (Clinical pressure application to locate the most tender spot in order to anatomically describe the site).
- Symptomatic for PF for any time period
- ≥18 years of age
- Able to provide informed consent
- Access to internet
Who cannot join
- Diabetes or neuropathy
- History of systemic diseases such as inflammatory joint disease, rheumatic, autoimmune or neurological conditions.
- Chronic pain syndrome or lumbosacral radiculitis
- Pregnancy
- Orthopaedic surgery (spinal/ lower limb within the last year)
- Corticosteroid injection for plantar fasciitis in the last 6 months (prior to onset)
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- Plantar heel pain related to fractures, tumours, infection, nerve entrapment or in the opinion of the assessing podiatrist confounded by any other medical condition
- Patient unable to complete exercises in self-help resources
- Unable to access internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Access to Virtual Resources for the Self-management of Plantar Fasciitis: A Proof of Concept and Feasibility Study
This proof of concept and feasibility study will adopt a mixed methods approach. The primary objectives will be to assess participants' acceptance and usability of a package of self-help videos for Plantar Fasciitis designed to be accessed shortly after suitable participants are referred to the podiatry service, and also the feasibility of conducting a future randomised controlled trial. The secondary objectives will be to assess the effects of the intervention on pain and quality of life.
Read the detailed description
This proof of concept and feasibility project will investigate the use of a self-help package of virtual resources for the treatment of plantar fasciitis. The research will involve a small group of ten, shortly after participants are referred to Cardiff \& Vale UHB podiatry service and join the waiting list.
The virtual resources will include short videos demonstrating ways of managing symptoms, such as gentle stretching exercises, and footwear recommendations. Participants will be given access to these resources to watch at their convenience. Patient reported outcome measures (foot pain, and quality of life) will be collated at baseline and periodically up to 6 weeks. Participants' acceptability of these resources will be assessed through interviews at the end of the six weeks.
The feasibility of conducting a future randomised controlled trial will be assessed by looking at recruitment rates, retention and any patient safety issues. It is hoped the long term benefit will be that participants joining the waiting list can engage with these resources at the earliest opportunity to help manage their symptoms.
This research is important because it presents an opportunity to work with participants at the start of joining a waiting list, and the benefits of early access to virtual resources could be applicable to a number of different health problems.
- Conditions
- Plantar Fascitis
- Being tested
- Early access to virtual resources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early access to virtual resourcesOther
Single arm study. Participants are given access to self help videos for the management of plantar fasciitis while they are on the waiting list
| Study group | Role | What they receive |
|---|---|---|
| Videos | Experimental | Single Arm study: All participants recruited to the study will be allocated to a single arm- "videos" in which participants will be able to access self help videos for plantar fasciitis Receives: Other: Early access to virtual resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of resources as assessed through semi structured interviews
End of study semi-structured interviews, analysed using a thematic approach.
Measured: 6 weeks
Usability of resources as assessed through semi structured interviews
End of study semi-structured interviews, analysed using a thematic approach
Measured: 6 weeks
Feasibility as assessed through recruitment and retention rates
End of study assessment of feasibility through recruitment and retention rates.
Measured: 6 weeks
Feasibility as assessed through adverse events.
End of study assessment of feasibility through adverse events
Measured: 6 weeks
Secondary outcomes (2)
Assess effects of intervention on pain using Visual Analogue Scale with higher scores indicating a worse outcome
Patient reported outcome measures recorded at baseline, 2 4 and 6 weeks
Measured: 6 weeks
Assess effects of intervention on quality of life using EQ5D (EuroQol) with higher scores indicating a worse outcome
Patient reported outcome measures at baseline, 2 4 and 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start27 Sep 2021
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071365
- Sponsor's protocol ID
- 8125
- Acronym
- EASE-P
- Status last verified
- Mar 2022
- First submitted
- 3 Aug 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Access to Virtual Resources for the Self-management of Plantar Fasciitis: A Proof of Concept and Feasibility Study
- ClinicalTrials.gov ID
- NCT05071365
- Acronym / sponsor ID
- EASE-P / 8125
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 8 Oct 2021 (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.
This proof of concept and feasibility study will adopt a mixed methods approach. The primary objectives will be to assess participants' acceptance and usability of a package of self-help videos for Plantar Fasciitis designed to be accessed shortly after suitable participants are referred to the podiatry service, and also the feasibility of conducting a future randomised controlled trial. The secondary objectives will be to assess the effects of the intervention on pain and quality of life.
Detailed description
This proof of concept and feasibility project will investigate the use of a self-help package of virtual resources for the treatment of plantar fasciitis. The research will involve a small group of ten, shortly after participants are referred to Cardiff \& Vale UHB podiatry service and join the waiting list.
The virtual resources will include short videos demonstrating ways of managing symptoms, such as gentle stretching exercises, and footwear recommendations. Participants will be given access to these resources to watch at their convenience. Patient reported outcome measures (foot pain, and quality of life) will be collated at baseline and periodically up to 6 weeks. Participants' acceptability of these resources will be assessed through interviews at the end of the six weeks.
The feasibility of conducting a future randomised controlled trial will be assessed by looking at recruitment rates, retention and any patient safety issues. It is hoped the long term benefit will be that participants joining the waiting list can engage with these resources at the earliest opportunity to help manage their symptoms.
This research is important because it presents an opportunity to work with participants at the start of joining a waiting list, and the benefits of early access to virtual resources could be applicable to a number of different health problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videos | Experimental | Other: Early access to virtual resourcesSingle Arm study: All participants recruited to the study will be allocated to a single arm- "videos" in which participants will be able to access self help videos for plantar fasciitis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -
- Diagnosis of Plantar Fasciitis by assessing podiatrist:
- Plantar medial heel pain: most noticeable with initial steps after a period of inactivity (post static dyskinesia) but also worse following prolonged weight bearing
- Pain with palpation of the proximal insertion of the plantar fascia, most commonly the medial calcaneal tubercle, the site of the plantar aponeurosis (Clinical pressure application to locate the most tender spot in order to anatomically describe the site).
- Symptomatic for PF for any time period
Key exclusion criteria (9 listed)
- Diabetes or neuropathy
- History of systemic diseases such as inflammatory joint disease, rheumatic, autoimmune or neurological conditions.
- Chronic pain syndrome or lumbosacral radiculitis
- Pregnancy
- Orthopaedic surgery (spinal/ lower limb within the last year)
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 |
|---|---|---|
| Early access to virtual resourcesSingle arm study. Participants are given access to self help videos for the management of plantar fasciitis while they are on the waiting list | Other | Videos |
Primary outcome
Acceptability of resources as assessed through semi structured interviews
Time frame: 6 weeks
End of study semi-structured interviews, analysed using a thematic approach.
Usability of resources as assessed through semi structured interviews
Time frame: 6 weeks
End of study semi-structured interviews, analysed using a thematic approach
Feasibility as assessed through recruitment and retention rates
Time frame: 6 weeks
End of study assessment of feasibility through recruitment and retention rates.
Feasibility as assessed through adverse events.
Time frame: 6 weeks
End of study assessment of feasibility through adverse events
2 secondary outcomes
Assess effects of intervention on pain using Visual Analogue Scale with higher scores indicating a worse outcome
Time frame: 6 weeks
Assess effects of intervention on quality of life using EQ5D (EuroQol) with higher scores indicating a worse outcome
Time frame: 6 weeks
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 9 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early access to virtual resources in people with Plantar Fascitis, 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 8 inclusion and 9 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 9 Feb 2023. 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?
Acceptability of resources as assessed through semi structured interviews (time frame: 6 weeks). The study lists 4 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 9 Feb 2023.