Surgical or Non-surgical Treatment of Plantar Fasciitis

NCT ID: NCT03854682

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2025-06-01

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

Conditions

Fasciitis, Plantar, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Surgical

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

Group Type: EXPERIMENTAL

Radiofrequency microtenotomy

Intervention Type: 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

Non-surgical

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

Group Type: ACTIVE_COMPARATOR

Strength training

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Resistance training

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Carsten Jensen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lillebaelt Hospital, Kolding

Kolding, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jens Wester, MD

Role: CONTACT

Jens.Wester1@rsyd.dk

+45 76362333

Bjarke Viberg, MD

Role: CONTACT

bjarke.viberg@rsyd.dk

+45 76362333

Facility Contacts

Jens Wester, MD

Role: primary

jens.wester1@rsyd.dk

Anne Hansen

Role: backup

Anne.Jess.Hansen@rsyd.dk

References

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.

Reference Type: DERIVED

PMID: 36195936 (View on PubMed)

Other Identifiers

67030

Identifier Type: -

Identifier Source: org_study_id