Clinical trial NCT03854682: Surgical or Non-surgical Treatment of Plantar Fasciitis
Official title: Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasciitis, Plantar, Chronic
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, blinded, parallel-group trial with balanced randomization \[1:1\], in accordance with CONSORT
Primary purpose: TREATMENT

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

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
* Diabetes
* Pregnant
* 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

Primary outcomes:
measure: Change in the Foot Health Status Questionnaire (FHSQ)
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: The Foot Health Status Questionnaire (FHSQ)
timeFrame: Change from baseline at 6 months
measure: Visual Analog Scale (VAS)
timeFrame: Change from baseline at 6 months
measure: Global Percieved Effect (GPE)
timeFrame: 1,3,6,12 months post-intervention
measure: Physical Activity Questionnaire (IPAQ)
timeFrame: Change from baseline at 6 months
Other outcomes:
measure: Compliance with the prescribed intervention
timeFrame: 6 months
measure: Complications and side-effects
timeFrame: 6 months
Locations:
city: Kolding
country: Denmark
facility: Lillebaelt Hospital, Kolding
Study officials:
References:
citation: Moller S, Riel H, Wester J, Simony A, Viberg B, Jensen C. Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial. Trials. 2022 Oct 4;23(1):845. doi: 10.1186/s13063-022-06785-w.