OPEN Research Support
head

Associate Professor
Carsten Jensen
Department of Orthopaedic Surgery, Odense University Hospital


Projekt styring
Projekt status    Planning
 
Data indsamlingsdatoer
Start 01.05.2018  
Slut 31.05.2022  
 



Operativ eller ikke-operativ behandling af plantar fasciopati (hælsporesyndrom) - Et klinisk lodtrækningsstudie

Short summary

This randomized controlled trail will investigate whether 40-60 year old people with heel pain should receive surgical or non-surgical treatment.  The primary outcome will be level of pain at six months with physical performance and sports participation as secondary outcomes. The hypothesis is that surgical treatment is better than non-surgical treatment measured by FHSQ-DK (pain)


Rationale

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 etiology of PF remains controversial but 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 as second-line treatment.

Microtenotomy coblation using a radiofrequency (RF) probe is a minimally invasive procedure for treating chronic PF. There have been no studies to show the effectiveness of such a procedure for plantar fasciitis

In this clinical trial we compare pain levels (FHSQ-DK) in people, who receive surgical treatment (radiofrequency microtenotomy + shoe inserts + patient education) and people who receive non-surgical treatment (strength training + shoe inserts + 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)



Description of the cohort

Eligable participants are men/woman older than 18 years. The 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) and able to read and understand Danish. The 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 or other reasons


Data and biological material

The Foot Health Status Questionnaire (FHSQ), Visual Analog Scale (VAS-pain), Global Percieved Effect (GPE), Physical Activity Questionnaire (IPAQ), adherence, complications and side-effects


Collaborating researchers and departments

This will be a prospective, blinded, parallel-group trial with balanced randomization [1:1], in

accordance with CONSORT conducted at a single-site at Dept. of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Sygehus Lillebaelt, by associate professor, PhD, Carsten Jensen

Publications associated with the project

We will publish the study protocol at www.clinicaltrials.org or similar journal and expect one main paper and possible a paper on the explorative part of the trial.