Surgical or Non-surgical Treatment of Plantar Fasciitis
- Conditions
- Fasciitis, Plantar, Chronic
- Registration Number
- NCT03854682
- Lead Sponsor
- University of Southern Denmark
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the Foot Health Status Questionnaire (FHSQ) Change from baseline at 6 months Subdomain foot pain score range 0-100, low values represent worse conditions
- Secondary Outcome Measures
Name Time Method The Foot Health Status Questionnaire (FHSQ) Change from baseline at 6 months Subdomains (foot related function, footwear and general foot health perception). Subdomain scores range from 0-100, low scores represent worse conditions
Visual Analog Scale (VAS) Change from baseline at 6 months Pain and scores range from 0-100, low values represent worse conditions
Global Percieved Effect (GPE) 1,3,6,12 months post-intervention A questionnaire using a 7-point likert scale to asses change in symptoms. The scores are categorized into (1-2 = deterioration of symptoms, 3-5 = Neutral, 6-7 improvement of symptoms).
Physical Activity Questionnaire (IPAQ) Change from baseline at 6 months Participation in sports and activities of daily living measured as MET-minutes/day or MET-minutes/week. Low MET-scores indicate limited activity. MET = metabolic equivalent of task
Trial Locations
- Locations (1)
Lillebaelt Hospital, Kolding
🇩🇰Kolding, Denmark
Lillebaelt Hospital, Kolding🇩🇰Kolding, DenmarkJens Wester, MDContactjens.wester1@rsyd.dkAnne HansenContactAnne.Jess.Hansen@rsyd.dk