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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma | Experimental |
| |
| Isotonoic Saline Solution | Sham Comparator |
| |
| Steroid (Triamcinolonacetonid) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Biological | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silkeborg Regional Hospital Department of Reumatology | Silkeborg | 8600 | Denmark |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010976 | Platelet Count |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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|
|
| Isotonic Saline Solutions | Procedure | 3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound. |
|
|
| Triamcinolonacetonid | Drug | Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound. |
|
|
| 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 |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D010979 | Platelet Function Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |