Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
ConditionTennis Elbow
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Ortopedico Rizzoli
About this trial
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 criteria
Qualifiers
Patients with clinical picture of epicondylitis;
Duration of symptoms > 3 months
Ultrasound picture of short or long radial extensor carpal tendinopathy;
Age > 18 and < 65
Disqualifiers
Patients undergoing previous surgical treatment on the epicondylar tendons;
Patients undergoing epicondylar infiltration in the previous 6 months;
Inability of patients to actively participate in clinical follow-up;
Incapacitated patients;
Trial design
Treatments tested in this trial
- Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)
- Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)
- Placebo (saline solution)
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov