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

NCT06040203 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2023-03-23

Last updated

2025-09-29

Condition(s) studied

Tennis Elbow

Investigational drug(s) / intervention(s)

Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) →Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)Placebo (saline solution)

Injection of autologous leukocyte rich platelet rich plasma (LR-PRP): Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.

Injection of autologous leukocyte poor platelet rich plasma (LP-PRP): Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.

Placebo (saline solution): Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.)

Primary outcome measure(s)

Patient-rated Tennis Elbow Evaluation (PRTEE) — 6 months follow-up
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do). The total score is the sum of the two subscales and has a range from 0 to 100.

Trial sites (1)

Facility	City	Region	Status
Istituto Ortopedico Rizzoli	Bologna	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06040203 on ClinicalTrials.gov ↗ ← All trials in Italy