Overview

This trial is active, not recruiting.

Condition plantar fasciitis
Treatments endoscopic surgery, methylprednisolon, lidokaine, training
Phase phase 4
Sponsor Bispebjerg Hospital
Collaborator The Danish Rheumatism Association
Start date April 2015
End date April 2017
Trial size 30 participants
Trial identifier NCT02448316, H-2-2012-151

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Endoscopic operation through 2 portals profound for the fascia plantaris
endoscopic surgery Fascial release
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,
(Active Comparator)
The standard treatment here acting as controle treatment . All patients are informed to decrease activity level, use shoes with good shock absorption and are recommended to use insoles (standard orthoses) for increased shock absorption. Training is supervised every third week by a physiotherapist (week 1,3,6,9), and daily training is carried out at home. Glucocorticoid injections of 1 ml Glucocorticosteroid (methylprednisolon 40 mg) and 1 ml of Lidokaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris are given every month until the fascia thickness is below 4 mm (max 3 injections).
methylprednisolon Depo-medrol
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
lidokaine Xylocain
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
training strength training
the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.

Primary Outcomes

Measure
Foot Function Index
time frame: 6 months
Foot Function Index
time frame: 12 months

Secondary Outcomes

Measure
100 mm VAS score for morning pain
time frame: 3 months
100 mm VAS score for morning pain
time frame: 6 months
100 mm VAS score for morning pain
time frame: 12 months
100 mm VAS score for morning pain
time frame: 24 months
100 mm VAS score for pain at function
time frame: 3 months
100 mm VAS score for pain at function
time frame: 6 months
100 mm VAS score for pain at function
time frame: 12 months
100 mm VAS score for pain at function
time frame: 24 months
single leg jumping length
time frame: 12 months
positionel MR scanning (pMRI)
time frame: 12 months
Tantalum pearle-calcaneus distance
time frame: 12 months
Foot Function Index
time frame: 24 months

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: - pain at the medial attachment of fascia plantaris - first step pain in the morning - symptoms for at least 3 months - ultrasound scanning at the first visit shows thickness of the proximal fascia above 4 mm - patient can read and understand danish Exclusion Criteria: - known arthritis inflammatory bowl disease, psoriasis or clinical signs of any of these. - leg ulcerations - long lasting oedema of the leg and foot - palpatory decreased puls in the foot - diabetes - reduced sensibility in the foot - infections in the foot - daily use of pain killers - pregnancy or planning to become pregnant - earlier operations on the foot, that is judged to complicate training. - patients assessed not to be able to participate in the training for other reasons - Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months

Additional Information

Official title Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.
Principal investigator Finn MD Johannsen, MD
Description Plantars fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development ( Orthosis and glucocorticoid injections are 2 widely used treatments and in most clinics the standard treatment, despite the fact that a recent Cochrane review found limited evidence for treatment of plantar heelpain. Once the condition gets chronic the response to several kinds of treatment is less predictable. However it has been demonstrated that endoscopic surgery for plantar fasciitis using a deep-fascial approach was successful in individuals with an active sports anamnesis, and all patients returned with this treatment to full athletic activities within 8-15 weeks. This high succesrate is not seen in conservative treatment with decrease in activity, training and injections of glucocorticosteroid, eventhough they had shorter disease duration. Therefore the investigators think it would be interesting to offer this minimal invasive operation to patients much earlier in the disease, especially as there is no reported severe sideeffects . However, surgery is very seldom compared with results of other treatment modalities, and no randomized studies exist on the effect of operation vs the normal conservative standard-treatment. 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.