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

NCT06040203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-09-29

No results posted yet for this 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

Conditions

  • Tennis Elbow

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

DRUG

Placebo (saline solution)

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

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Enrico Guerra, MD · Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06040203 on ClinicalTrials.gov