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Clinical Trials/NCT03854682
NCT03854682
Recruiting
N/A

Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial

University of Southern Denmark1 site in 1 country70 target enrollmentMay 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fasciitis, Plantar, Chronic
Sponsor
University of Southern Denmark
Enrollment
70
Locations
1
Primary Endpoint
Change in the Foot Health Status Questionnaire (FHSQ)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Plantar fasciitis (PF) is one of the most common causes of heel pain in 40-60 year old people. Approximately 10% of the population is affected by the disorder and the PF prevalence is 3.6-7.0%. The risk factors include decreased ankle dorsiflexion, overweight (BMI> 27), pronated foot position, and prolonged work and activity-related weight bearing. The condition affects both active and less active people.

The typical symptoms are pain around the attachment of the foot's tendon mirror (fascia plantaris), especially the medial part. The pain is well defined and occurs during weight bearing activities or during the first steps after rest. The walking pattern is changed to relieve pain. Ultrasound scan is used to confirm the diagnosis (thickened tendon mirror> 4 mm). The condition is described as inflammatory, but the relationship between the initial inflammatory condition and the chronic tendon mirror overload injury (fasciopathy) is unknown and marked by degenerative changes.

Although the majority of people improve within 1-2 years, the long-term prognosis is unknown. People with symptoms lasting > 7 months have poor prognosis and should be offered other treatment. Non-surgical treatment is often first line of treatment followed by surgical treatment.

In this clinical trial investigators compare pain levels (FHSQ-DK) in people, who receive surgical treatment (radiofrequency microtenotomy, shoe inserts and patient education) and people who receive non-surgical treatment (strength training, shoe inserts and patient education) with a primary end-point at 6 months. The hypothesis is that surgical treatment is better than non-surgical treatment measured by FHSQ-DK (pain)

Detailed Description

To be completed later

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
June 1, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carsten Jensen

Associate professor

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • VAS pain score \> 30 within last 7 days
  • Plantar heel pain\> 7 months
  • Palpation soreness fascia plantaris at heel
  • Plantar heel pain during first steps (First-step sign)
  • Read and understand Danish

Exclusion Criteria

  • Systemic diseases or neuropathy
  • Previous heel surgery on same foot
  • Cortisone injections within past 3 months
  • Bilateral symptom onset within past 7 days
  • Signs of tarsal tunnel
  • Facia plantaris thickness of less than 4 mm
  • Performed message / head recovery / stretching within the past month
  • Any treatment for plantar pain within the past 3 months
  • Other reasons

Outcomes

Primary Outcomes

Change in the Foot Health Status Questionnaire (FHSQ)

Time Frame: Change from baseline at 6 months

Subdomain foot pain score range 0-100, low values represent worse conditions

Secondary Outcomes

  • The Foot Health Status Questionnaire (FHSQ)(Change from baseline at 6 months)
  • Visual Analog Scale (VAS)(Change from baseline at 6 months)
  • Global Percieved Effect (GPE)(1,3,6,12 months post-intervention)
  • Physical Activity Questionnaire (IPAQ)(Change from baseline at 6 months)

Study Sites (1)

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