Surgical or Non-surgical Treatment of Plantar Fasciitis

Study Overview
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Brief Summary
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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
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To be completed later

Official Title
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Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial

Conditions
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Fasciitis, Plantar, Chronic

Intervention / Treatment
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* Procedure: Radiofrequency microtenotomy
* Behavioral: Strength training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, blinded, parallel-group trial with balanced randomization [1:1], in accordance with CONSORT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical<br>Radiofrequency microtenotomy (RF): A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied | Procedure: Radiofrequency microtenotomy<br>* A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied<br>|
| Active Comparator: Non-surgical<br>Strength training: Consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved | Behavioral: Strength training<br>* Non-surgical treatment consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved<br>* Other names: Resistance training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Foot Health Status Questionnaire (FHSQ) | Subdomain foot pain score range 0-100, low values represent worse conditions | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Foot Health Status Questionnaire (FHSQ) | Subdomains (foot related function, footwear and general foot health perception). Subdomain scores range from 0-100, low scores represent worse conditions | Change from baseline at 6 months | 
| Visual Analog Scale (VAS) | Pain and scores range from 0-100, low values represent worse conditions | Change from baseline at 6 months | 
| Global Percieved Effect (GPE) | 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). | 1,3,6,12 months post-intervention | 
| Physical Activity Questionnaire (IPAQ) | 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 | Change from baseline at 6 months |