Comparing different types of PRP injections for treating tennis elbow

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

This study is testing whether two different types of PRP injections can help people with tennis elbow who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT06040203 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with chronic epicondylitis symptoms lasting over three months who have not benefited from conservative treatments.

Not a fit: Patients who have undergone previous surgical treatment on the elbow tendons or recent injections in the past six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from chronic tennis elbow.

How similar studies have performed: Previous studies have shown promising results with PRP injections for various musculoskeletal conditions, suggesting potential success for this approach in treating epicondylitis.

Eligibility criteria

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 this trial is running

Bologna

• 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

Conditions Tennis Elbow; Platelet rich plasma; Leukocyte-rich PRP; Leukocyte-poor PRP; PRP; PRP injection; Double-blind randomized controlled clinical trial