NCT03854682: SOFT

Surgical or Non-surgical Treatment of Plantar Fasciitis

Status unknown NA Last updated 18 May 2022

What this trial tests

NA trial testing Radiofrequency microtenotomy in Fasciitis, Plantar, Chronic in 70 participants. Status unknown.

Timeline

1 May 2020

Primary endpoint
1 June 2024

1 June 2025

Quick facts

Lead sponsor	University of Southern Denmark
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	1 May 2020
Primary completion	1 June 2024
Estimated completion	1 June 2025
Sites	1 location across Denmark

Drugs / interventions tested

• Radiofrequency microtenotomy
• Strength training

Conditions studied

• Fasciitis, Plantar, Chronic — all drugs for Fasciitis, Plantar, Chronic →

Sponsor

University of Southern Denmark

Who can join

18 and older, any sex, with Fasciitis, Plantar, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial.
   Møller S, Riel H, Wester J, Simony A, et al · · 2022 · cited 2× · PMID 36195936 · DOI 10.1186/s13063-022-06785-w
2. Surgical or Non-Surgical Treatment of Plantar Fasciopathy (SOFT). Study protocol for a randomized controlled trial
   Møller S, Riel H, Wester J, Jensen C, et al · · 2022 · DOI 10.21203/rs.3.rs-1522331/v1