Surgical or Non-surgical Treatment of Plantar Fasciitis (SOFT)

  • End date
    Jun 1, 2025
  • participants needed
  • sponsor
    University of Southern Denmark
Updated on 24 May 2022
Accepts healthy volunteers


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)


To be completed later

Condition Fasciitis, Plantar, Chronic
Treatment Strength training, Radiofrequency microtenotomy
Clinical Study IdentifierNCT03854682
SponsorUniversity of Southern Denmark
Last Modified on24 May 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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