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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05066919

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 %.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fascitis Surgical Treatment Non-operative Treatment Randomized Study	Procedure: Open plantar fasciotomy Other: Conservative treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Self-Reported-Foot-And-Ankle Score (SEFAS) [24 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Jantzen, MD., Principal Investigator, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT05066919

Other Study ID Numbers:

78652

First Posted:

Oct 4, 2021

Last Update Posted:

Oct 18, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fasciitis

Fasciitis, Plantar

Study Results

No Results Posted as of Oct 18, 2021