Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution

Study Overview
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Brief Summary
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We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution. All injections are guided by ultrasonography.

Detailed Description
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Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.

Official Title
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Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Biological: Platelet Rich Plasma
* Procedure: Isotonic Saline Solutions
* Drug: Triamcinolonacetonid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duration of tennis elbow > 6 months Doppler activity on ultrasonography Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger. Exclusion Criteria: Inflammatory disease. Fibromyalgia. Pain in hand or shoulder/neck in the same arm as being treated. Anticoagulation treatment. Wounds around the elbow. Treatment with steroids within the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma<br> | Biological: Platelet Rich Plasma<br>* 27ml of autologous whole blood added to 3ml of ACD-A (Citrate Anticoagulant). After separation of the platelets, a high concentration of platelets (3-4ml Platelet Rich Plasma) is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.<br>* Other names: Blood Platelets;|
| Sham Comparator: Isotonoic Saline Solution<br> | Procedure: Isotonic Saline Solutions<br>* 3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.<br>* Other names: Physiological Saline Solution;|
| Active Comparator: Steroid (Triamcinolonacetonid)<br> | Drug: Triamcinolonacetonid<br>* Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.<br>* Other names: Kenalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire. | We use the PRTEE questionaire, which is validated for tennis elbow. | first day, 1 months, 3 months, 6 months, 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Disability | We use the PRTEE questionaire, validated for tennis elbow. | First day, 1 month, 3 months, 6 months, 12 months | 
| Ultrasonographic changes | We meassure ultrasonographic changes in: tendon thickness and doppler activity. | first day, 1 months, 3 months, 6 months, 12 months | 
| Adverse events | The number of adverse events leading to withdrawal | through out the entire 12 months | 
| Pain induced by the treatment | A numeric scale 0-10 adressing if the treatment caused any aditional pain, and the duration: <1 week, 1-2 week, 3-4 weeks, > 4 weeks. | 1 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Epicondylitis, Tennis Elbow, Epicondylitis Lateralis