Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
Trial Parameters
Brief Summary
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment
Eligibility Criteria
Inclusion Criteria: Patients with epicondylitis of the elbow: 1. Patients with clinical picture of epicondylitis; 2. Duration of symptoms \> 3 months 3. Ultrasound picture of short or long radial extensor carpal tendinopathy; 4. Age \> 18 and \< 65 5. Both sexes; 6. Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months; 7. Hemoglobin \> 11 g/dl; 8. Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination); 9. Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab 10. No clinically significant electrocardiographic changes (Recently performed ECG); 11. Ability and consent of the patient to actively participate in clinical follow-up; 12. Signature of informed consent. Exclusion Criteria: 1. Patients undergoing previous surgical treatment on the epicondylar tendons; 2. Patients undergoing epicondylar infiltration in the previous 6 months; 3. Inability of patients to actively participate in clinical follow-up; 4. Incapacitated pat