Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution
|ClinicalTrials.gov Identifier: NCT01109446|
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : February 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis||Biological: Platelet Rich Plasma Procedure: Isotonic Saline Solutions Drug: Triamcinolonacetonid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
|Experimental: Platelet Rich Plasma||
Biological: Platelet Rich Plasma
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.
|Sham Comparator: Isotonoic Saline Solution||
Procedure: Isotonic Saline Solutions
3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
Other Name: Physiological Saline Solution
|Active Comparator: Steroid (Triamcinolonacetonid)||
Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.
Other Name: Kenalog
- Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire. [ Time Frame: first day, 1 months, 3 months, 6 months, 12 months. ]We use the PRTEE questionaire, which is validated for tennis elbow.
- Functional Disability [ Time Frame: First day, 1 month, 3 months, 6 months, 12 months ]We use the PRTEE questionaire, validated for tennis elbow.
- Ultrasonographic changes [ Time Frame: first day, 1 months, 3 months, 6 months, 12 months ]We meassure ultrasonographic changes in: tendon thickness and doppler activity.
- Adverse events [ Time Frame: through out the entire 12 months ]The number of adverse events leading to withdrawal
- Pain induced by the treatment [ Time Frame: 1 months after 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109446
|Silkeborg Regional Hospital Department of Reumatology|
|Silkeborg, Denmark, 8600|