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

NCT05071365 | Completed

• 1 other identifier: 8125
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (4)

• Acceptability of resources as assessed through semi structured interviews

  End of study semi-structured interviews, analysed using a thematic approach.

  6 weeks

• Usability of resources as assessed through semi structured interviews

  End of study semi-structured interviews, analysed using a thematic approach

  6 weeks

• Feasibility as assessed through recruitment and retention rates

  End of study assessment of feasibility through recruitment and retention rates.

  6 weeks

• Feasibility as assessed through adverse events.

  End of study assessment of feasibility through adverse events

  6 weeks

Secondary Outcomes (2)

• Assess effects of intervention on pain using Visual Analogue Scale with higher scores indicating a worse outcome

  6 weeks

• Assess effects of intervention on quality of life using EQ5D (EuroQol) with higher scores indicating a worse outcome

  6 weeks

Study Arms (1)

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

Other: Early access to virtual resources

Interventions

Early access to virtual resources OTHER

Single arm study. Participants are given access to self help videos for the management of plantar fasciitis while they are on the waiting list

Videos

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Clinical research facility

Cardiff, CF14 4XW, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: October 8, 2021
• Study Start: September 27, 2021
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: February 9, 2023

Record last verified: 2022-03

Locations

GB (1)