Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Sep 10, 2023

Keywords

ClinConnect Summary

The EPIC-PRP study is a clinical trial looking at different treatments for tennis elbow, also known as epicondylitis. Specifically, the trial compares two types of platelet-rich plasma (PRP) injections—one with white blood cells (leukocyte-rich) and one without (leukocyte-free)—against a placebo injection of saline solution. The goal is to see which treatment helps reduce pain and improve function in patients who have not found relief from other treatments for at least three months.

To participate in this study, individuals must be between the ages of 18 and 65 and have experienced elbow pain for more than three months that hasn’t improved with other treatments. They should also be able to take part in follow-up visits and provide consent to join. Participants will receive injections and will be monitored for how well they respond to the treatment and if they experience any side effects. This research aims to find a safe and effective way to help those suffering from tennis elbow get back to their daily activities.

Gender

ALL

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 patients;
• • 5. Patients with states of immunodepression;
• • 6. Patients with fibromyalgia;
• • 7. Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
• • 8. Patients with uncontrolled thyroid metabolic disorders;
• • 9. Patients abusing alcoholic beverages, drugs or medications;
• • 10. Patients who have taken NSAIDs in the 3 days prior to blood collection;
• • 11. Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
• • 12. Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
• • 13. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
• • 14. Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)