Plantar Fasciitis, Operation or Conservative Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Procedure: endoscopic surgery
* Drug: methylprednisolon
* Drug: lidokaine
* Behavioral: Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endoscopic surgery<br>Endoscopic operation through 2 portals profound for the fascia plantaris | Procedure: endoscopic surgery<br>* 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,<br>* Other names: Training;|
| Active Comparator: conservative treatment<br>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). | Drug: methylprednisolon<br>* 1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible<br>* Other names: Glucocorticosteroid injection;Drug: lidokaine<br>* 1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible<br>* Other names: Xylocain;Behavioral: Training<br>* the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.<br>* Other names: stretching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Function Index | Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230 | 6 months | 
| Foot Function Index | Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100 mm VAS score for morning pain |  | 3 months | 
| 100 mm VAS score for morning pain |  | 6 months | 
| 100 mm VAS score for morning pain |  | 12 months | 
| 100 mm VAS score for morning pain |  | 24 months | 
| 100 mm VAS score for pain at function |  | 3 months | 
| 100 mm VAS score for pain at function |  | 6 months | 
| 100 mm VAS score for pain at function |  | 12 months | 
| 100 mm VAS score for pain at function |  | 24 months | 
| single leg jumping length | Standing on the diseased leg, the patient jumps as far as possible landing on the same leg. the best of 3 trials. | 12 months | 
| positionel MR scanning (pMRI) | only for the operated patients the change in bone position in standing is measured using a pMRI, where bone position is measured in supine and standing before and 12 months after the operation. This will also include patients referred directly to operation and therefore not included in the RCT | 12 months | 
| Tantalum pearle-calcaneus distance | only for operated patients the distance from calcaneus to a Tantalum pearle inserted in the plantar fascia during operation is measured by lying and standing X-ray. This will also include patients referred directly to operation and therefore not included in the RCT | 12 months | 
| Foot Function Index | Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230 | 24 months |