Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study

The purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. The study is performed as a randomized trial with the inclusion of 32 patients divided between open plantar fasciectomy and conservative treatment.

The primary endpoint is Self-Reported-Foot-And-Ankle Score (SEFAS-score) after 24 months.

Secondary endpoints includes: Pain (Visual analogue score) at first step, rest and activity after 3, 6, 12 and 24 months, SEFAS-score after 3, 6 og 12 months, changes in gait after 6 months (measured with gait-analysis). All endpoints are measured at inclusion.

The power calculation is based on the assumption that surgical treatment gives an improvement in SEFAS-score of 10 points (SD 7.9) after 24 months when compared to conservative treatment together with an alpha-value of 5 % and a beta value of 90 %.

Study Overview

• Status: Not yet recruiting
• Conditions: Plantar Fascitis; Surgical Treatment; Randomized Study; Non-operative Treatment
• Intervention / Treatment: Procedure: Open plantar fasciotomy; Other: Conservative treatment

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years.
• Isolated plantar fasciitis through more than 6 months
• Ultrasonic verification of diagnosis (plantar fascia >4 mm)
• Ability to follow the post-operative- and conservative plans
• Able to give informed consent.

Exclusion Criteria:

• Previous surgical treatment of plantar fasciitis or surgery around the heel
• Rheumatic disease
• Diabetes
• Dementia
• Neuropathy
• Known alcohol abuse
• Pareses/paralysis of the affected extremity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operative treatment; Patients treated with open plantar fasciotomy	Procedure: Open plantar fasciotomy; In the surgical treated group, the plantar fascia is defined percutaneously (medial and lateral margin). An incision is then made just distal to the heel pad medially over the plantar fascia. A resection is performed 1 cm in length with a width corresponding to 50% of the medial band. The skin is sutured with nylon/nonresorbable suture. Postoperatively, the operated foot is elevated for the first 24 hours. Then free mobilization in postoperative shoe (ProCare shoe) is allowed. The dressing is left untouched for 3-5 days, after which it can be changed to a patch. After 14 days the sutures are removed and the patient allowed using regular shoes.
Active Comparator: Conservative treatment; Patients treated non-operatively with exercise	Other: Conservative treatment; In the conservative treatment group, patients are instructed in performing stretching exercises with plantar fascia specific stretching exercises 10 x 10 seconds, 3 times daily and high load strength training are every other day for 3 months. Each high load strength exercise consists of 3 seconds of concentric phase (lifting up with the heel) and 3 seconds of eccentric phase (lowering the heel) with 2 seconds of isometric pause (pause at maximum lifted heel). 12 repetitions max (RM) are performed, defined as the maximum (over) weight the patient can lift 12 times with full range of motion while performing the exercise correctly. 3 x 12 exercises are performed per workout. After 2 weeks, the load is while the number of repetitions is reduced to 10 RM with an increase to 4 repetitions per workout. After 4 weeks the intensity is increased to 8RM with 5 set. Patients are instructed to increase the load throughout the training period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported-Foot-And-Ankle Score (SEFAS)	The questionnaire contains 12 items with 5 response options. The questionnaire covers different constructs, which are not reported separately in subscales. The most important of these constructs are pain, function, and limitation of function. Each of the 12 multiple-choice questions scores from 0 to 4 where a sum of 0 points represents the most severe disability and 48 represents normal function.	24 Months

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): October 31, 2025
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 78652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No