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Compares treatment options for Tennis Elbow
Official title Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
ClinicalTrials.gov ID: NCT06040203
What this study is testing
What is Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)?
Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for tennis elbow.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility criteria
- 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.
- 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.