Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial

NCT06040203 NA RECRUITING

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

Details

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	RECRUITING
Enrolment	240
Start date	2023-03-23
Completion	2027-03

Conditions

• Tennis Elbow

Interventions

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

Primary outcomes

• 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.

Countries

Italy