Surgical or Non-surgical Treatment of Plantar Fasciitis

NCT03854682 | Completed DMC

• 1 other identifier: 67030
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Fasciitis, Plantar, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Foot Health Status Questionnaire (FHSQ)

  Change from baseline at 6 months

• Visual Analog Scale (VAS)

  Change from baseline at 6 months

• Global Percieved Effect (GPE)

  1,3,6,12 months post-intervention

• Physical Activity Questionnaire (IPAQ)

  Change from baseline at 6 months

Other Outcomes (2)

• Compliance with the prescribed intervention

  6 months

• Complications and side-effects

  6 months

Study Arms (2)

Surgical

EXPERIMENTAL

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

Non-surgical

ACTIVE COMPARATOR

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

Interventions

Radiofrequency microtenotomy PROCEDURE

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

Surgical

Strength training BEHAVIORAL

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

Also known as: Resistance training

Non-surgical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Lillebaelt Hospital, Kolding

Kolding, 6000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36195936 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to treatment allocation of patients, physiotherapists (health care providers) will not be possible due to the nature of the interventions. However, independent data collectors will be responsible for baseline and follow-up assessments, while all self-reported outcome measures will be made available to the patients electronically, and responses entered into a database identified by identification numbers only. The data analyst will be unaware of the treatment allocation as data will be analyzed using recoded identification numbers. The recoding will be performed by an independent person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A prospective, blinded, parallel-group trial with balanced randomization \[1:1\], in accordance with CONSORT

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 26, 2019
• Study Start: May 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)