CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
methylprednisolon +3 moredrug
Likely dose
methylprednisolon 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02448316
NCT02448316Phase 4Completed

Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.

Bispebjerg Hospital·interventional·Posted May 19, 2015·Updated Jul 11, 2018

In Brief

A Phase 4 clinical trial evaluating endoscopic surgery, methylprednisolon, and 2 other interventions for Plantar Fasciitis. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 19, 2015
Enrollment StartApr 1, 2015
Primary CompletionNov 1, 2016
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.1 years ago

Interventions

endoscopic surgeryprocedure

Through 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus. A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion). Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days,

methylprednisolondrug

1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible

lidokainedrug

1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible

Trainingbehavioral

the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.