💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.)
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