Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment.

Detailed Description
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Plantar 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 with proven effect. However treatment of overuse injury in other tendon/aponeurosis-like structures, has over the later years been dominated by an increasing documentation of a good curative effect of heavy controlled mechanical loading (eccentric strength exercises or heavy slow concentric strength training) upon tendinopathies in Achilles or patella tendon. However, no studies have looked at the influence of physical training (e.g. strength training) on the diseased plantar aponeurosis. Also no studies have looked at the effect of a combination of giving local glucocorticoid injection and training on this or other tendon overuse entities. We hypothesize that heavy strength training will have a positive effect upon PF, and that a combination of training and glucocorticoid injections will have an additive effect upon this disease and be even more effective than each of the treatments alone. Glucocorticoid injection acting as the standard control treatment.

Official Title
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Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: Training
* Drug: Glucocorticosteroid injection
* Behavioral: Reduction in impact


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. Age 20-65 years Ultrasound scanning at the first visit shows thickness of the 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 Longlasting 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 Patient 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training<br>strengthening and stretching exercises. | Other: Training<br>* Patients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly<br>* Other names: stretching;Behavioral: Reduction in impact<br>* advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.<br>* Other names: Shock absorbtion;|
| Active Comparator: Glucocorticosteroid injection<br>Injection of 40 mg methylprednisolone. | Drug: Glucocorticosteroid injection<br>* Ultra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris. Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections).<br>* Other names: Depo-medrol;Behavioral: Reduction in impact<br>* advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.<br>* Other names: Shock absorbtion;|
| Active Comparator: Training and Glucocorticosteroid injections<br>A combination treatment of the two above. | Other: Training<br>* Patients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly<br>* Other names: stretching;Drug: Glucocorticosteroid injection<br>* Ultra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris. Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections).<br>* Other names: Depo-medrol;Behavioral: Reduction in impact<br>* advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.<br>* Other names: Shock absorbtion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100 mm VAS score pain at function. Average pain during everyday living. |  | 6 month | 
| Foot Function Index | Foot function Index is a validated score for patients with 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 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100 mm VAS score for morning pain |  | at entry, 3 month (after intervention), 6 month, 12 month, 24 month | 
| Ultrasound scanning thickness measure | measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning | at entry, 3 month (after intervention), 6 month, 12 month, 24 month | 
| 100 mm VAS score pain at function. Average pain during everyday living. |  | 3 months, 12 months, 24 months | 
| Foot Function Index | Foot function Index is a validated score for patients with 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. | 3 month, 12 month, 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plantar fasciitis, Treatment, Training, Glucocorticosteroid injection