Early Access to Virtual Resources for the Self-management of Plantar Fasciitis (EASE-P)
Primary Purpose
Plantar Fascitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Early access to virtual resources
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fascitis
Eligibility Criteria
Inclusion Criteria:
-
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Clinical research facility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Videos
Arm Description
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
Outcomes
Primary Outcome Measures
Acceptability of resources as assessed through semi structured interviews
End of study semi-structured interviews, analysed using a thematic approach.
Usability of resources as assessed through semi structured interviews
End of study semi-structured interviews, analysed using a thematic approach
Feasibility as assessed through recruitment and retention rates
End of study assessment of feasibility through recruitment and retention rates.
Feasibility as assessed through adverse events.
End of study assessment of feasibility through adverse events
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05071365
First Posted
August 3, 2021
Last Updated
February 8, 2023
Sponsor
Cardiff and Vale University Health Board
1. Study Identification
Unique Protocol Identification Number
NCT05071365
Brief Title
Early Access to Virtual Resources for the Self-management of Plantar Fasciitis
Acronym
EASE-P
Official Title
Early Access to Virtual Resources for the Self-management of Plantar Fasciitis: A Proof of Concept and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
July 4, 2022 (Actual)
Study Completion Date
July 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff and Vale University Health Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videos
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Early access to virtual resources
Intervention Description
Single arm study. Participants are given access to self help videos for the management of plantar fasciitis while they are on the waiting list
Primary Outcome Measure Information:
Title
Acceptability of resources as assessed through semi structured interviews
Description
End of study semi-structured interviews, analysed using a thematic approach.
Time Frame
6 weeks
Title
Usability of resources as assessed through semi structured interviews
Description
End of study semi-structured interviews, analysed using a thematic approach
Time Frame
6 weeks
Title
Feasibility as assessed through recruitment and retention rates
Description
End of study assessment of feasibility through recruitment and retention rates.
Time Frame
6 weeks
Title
Feasibility as assessed through adverse events.
Description
End of study assessment of feasibility through adverse events
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assess effects of intervention on pain using Visual Analogue Scale with higher scores indicating a worse outcome
Description
Patient reported outcome measures recorded at baseline, 2 4 and 6 weeks
Time Frame
6 weeks
Title
Assess effects of intervention on quality of life using EQ5D (EuroQol) with higher scores indicating a worse outcome
Description
Patient reported outcome measures at baseline, 2 4 and 6 weeks
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
Facility Information:
Facility Name
Clinical research facility
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Early Access to Virtual Resources for the Self-management of Plantar Fasciitis
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