Early Access to Virtual Resources for the Self-management of Plantar Fasciitis

Not Applicable

Completed

• Conditions: Plantar Fascitis
• Interventions: Other: Early access to virtual resources

• Registration Number: NCT05071365
• Lead Sponsor: Cardiff and Vale University Health Board

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.

Study Timeline

• Study First Submitted: 2021-08-03
• Study Start: 2021-09-27
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-08
• Status Verified: 2022-03
• Primary Completion: 2022-07-04
• Study Completion: 2022-07-04
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Videos	Early access to virtual resources	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

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed through recruitment and retention rates	6 weeks	End of study assessment of feasibility through recruitment and retention rates.
Acceptability of resources as assessed through semi structured interviews	6 weeks	End of study semi-structured interviews, analysed using a thematic approach.
Feasibility as assessed through adverse events.	6 weeks	End of study assessment of feasibility through adverse events
Usability of resources as assessed through semi structured interviews	6 weeks	End of study semi-structured interviews, analysed using a thematic approach

Secondary Outcome Measures

Name	Time	Method
Assess effects of intervention on pain using Visual Analogue Scale with higher scores indicating a worse outcome	6 weeks	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	6 weeks	Patient reported outcome measures at baseline, 2 4 and 6 weeks

Trial Locations

Locations (1)

Clinical research facility; 🇬🇧 Cardiff, United Kingdom