Surgical or Non-surgical Treatment of Plantar Fasciitis

Fasciitis, Plantar, Chronic Clinical Trial

— SOFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03854682
• Other study ID #: 67030
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2022
• Source: University of Southern Denmark
• Contact: Jens Wester, MD
• Phone: +45 76362333
• Email: Jens.Wester1[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

To be completed later

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Fasciitis, Plantar, Chronic

Intervention

Procedure:
• Radiofrequency microtenotomy
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

Behavioral:
• Strength training
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

Locations

Country	Name	City	State
Denmark	Lillebaelt Hospital, Kolding	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance with the prescribed intervention	Tracking adherence to exercise and reasons for non-complience	6 months
Other	Complications and side-effects	Review of medical records for complications and side-effects	6 months
Primary	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	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
Secondary	Visual Analog Scale (VAS)	Pain and scores range from 0-100, low values represent worse conditions	Change from baseline at 6 months
Secondary	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
Secondary	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