Status:
RECRUITING
Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 tri...
Detailed Description
Patients with elbow epicondylitis will be included in a double-blind, randomized controlled trial, in which one group of patients will be treated with an echo-guided injection of LP-PRP (low leukocyte...
Eligibility Criteria
Inclusion
- Patients with epicondylitis of the elbow:
- 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
- Both sexes;
- Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;
- Hemoglobin \> 11 g/dl;
- Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
- Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- No clinically significant electrocardiographic changes (Recently performed ECG);
- Ability and consent of the patient to actively participate in clinical follow-up;
- Signature of informed consent.
Exclusion
- 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;
- Patients with states of immunodepression;
- Patients with fibromyalgia;
- Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Patients who have taken NSAIDs in the 3 days prior to blood collection;
- Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
- Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
- Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)
Key Trial Info
Start Date :
March 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06040203
Start Date
March 23 2023
End Date
March 1 2027
Last Update
September 29 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136