Comparing different types of PRP injections for treating tennis elbow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EPIC-PRP study is a double-blind randomized controlled trial designed to evaluate the effectiveness of echo-guided injections of leukocyte-rich platelet-rich plasma (LR-PRP) and leukocyte-poor platelet-rich plasma (LP-PRP) compared to a saline placebo in patients with tennis elbow who have not responded to conservative treatments. Participants will be randomly assigned to one of three groups and will receive a single injection, followed by clinical evaluations at multiple time points to assess improvement and any adverse events. The study aims to provide insights into the safety and efficacy of these injection techniques for managing chronic elbow pain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with epicondylitis of the elbow:

1. Patients with clinical picture of epicondylitis;
2. Duration of symptoms \> 3 months
3. Ultrasound picture of short or long radial extensor carpal tendinopathy;
4. Age \> 18 and \< 65
5. Both sexes;
6. Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;
7. Hemoglobin \> 11 g/dl;
8. Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
9. Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
10. No clinically significant electrocardiographic changes (Recently performed ECG);
11. Ability and consent of the patient to actively participate in clinical follow-up;
12. Signature of informed consent.

Exclusion Criteria:

1. Patients undergoing previous surgical treatment on the epicondylar tendons;
2. Patients undergoing epicondylar infiltration in the previous 6 months;
3. Inability of patients to actively participate in clinical follow-up;
4. Incapacitated patients;
5. Patients with states of immunodepression;
6. Patients with fibromyalgia;
7. Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
8. Patients with uncontrolled thyroid metabolic disorders;
9. Patients abusing alcoholic beverages, drugs or medications;
10. Patients who have taken NSAIDs in the 3 days prior to blood collection;
11. Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
12. Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
13. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
14. Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Enrico Guerra, MD — Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito
• Study coordinator: Enrico Guerra, MD
• Email: enrico.guerra@ior.it
• Phone: 0516366567

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Heavy slow-resistance wrist exercises and shoulder stabilization to reduce pain and improve grip in tennis elbow

  This test will compare six weeks of heavy slow-resistance wrist exercises against shoulder stabilization exercises to see which better reduces pain and improves grip and function in adults aged 30–50 with tennis elbow.

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• Shockwave therapy versus eccentric exercises for tennis elbow

  This trial tests whether shockwave therapy or a five-week eccentric exercise program works better to reduce pain and improve function in adults aged 20–50 with tennis elbow.

  Recruiting Ibadat International University, Islamabad · Islamabad · NCT07523893

• High- vs low-dose high-intensity laser therapy for tennis elbow

  This tests whether higher or lower doses of high-intensity laser therapy help adults with recent-onset tennis elbow.

  Recruiting Phase 4 Kaohsiung Medical University Chung-Ho Memorial Hospital · Kaohsiung City · NCT07342426

• Pressure-pain sensitivity and natural pain-blocking after a cold hand immersion in people with and without tennis elbow

  This will test whether people with tennis elbow feel pressure pain differently and whether their body's natural pain‑blocking response changes before, during, and after a cold hand immersion compared with people without elbow pain.

  Recruiting The Hashemite University · Zarqa, Zarqa Governorate · NCT07178288

• Mesotherapy versus extracorporeal shock wave therapy for tennis elbow

  This trial will test whether mesotherapy works as well as extracorporeal shock wave therapy to reduce pain and improve function in adults (18–65) with tennis elbow.

  Recruiting Haydarpasa Numune Training and Research Hospital · Istanbul · NCT07043335

• Comparing different injection treatments for tennis elbow

  This study tests different injection treatments for tennis elbow to see which one helps reduce pain and improve function for people with this condition.

  Recruiting Wrightington, Wigan and Leigh NHS Foundation Trust · Wigan, Lancashire · NCT03984955

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.