Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis

NCT06040203 | Recruiting

• 1 other identifier: Epic-PRP
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 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

Conditions

Tennis Elbow

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient-rated Tennis Elbow Evaluation (PRTEE)

  PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do). The total score is the sum of the two subscales and has a range from 0 to 100.

  6 months follow-up

Secondary Outcomes (12)

• Patient-rated Tennis Elbow Evaluation (PRTEE)

  baseline, 1 month, 3 months and 12 months follow-up

• Disability of the arm, shoulder and hand score (DASH)

  baseline, 1 month, 3 months, 6 months and 12 months follow-up

• Tegner Activity Level Scale

  baseline, 1 month, 3 months, 6 and 12 months follow-up

• Oxford Elbow Score (OES)

  baseline, 1 month, 3 months, 6 and 12 months follow-up

• Visual Analogue Scale (VAS)

  baseline, 1 month, 3 months, 6 and 12 months follow-up

Study Arms (3)

Leukocyte-rich Platelet rich plasma (LR-PRP)

EXPERIMENTAL

This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.

Biological: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)

Leukocyte-poor Platelet rich plasma (LP-PRP)

EXPERIMENTAL

This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.

Biological: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)

Saline solution

PLACEBO COMPARATOR

This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list.

Drug: Placebo (saline solution)

Interventions

Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) BIOLOGICAL

Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.

Leukocyte-rich Platelet rich plasma (LR-PRP)

Injection of autologous leukocyte poor platelet rich plasma (LP-PRP) BIOLOGICAL

Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.

Leukocyte-poor Platelet rich plasma (LP-PRP)

Placebo (saline solution) DRUG

Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.

Saline solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify 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;
• 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.)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (5)

• Kim GM, Yoo SJ, Choi S, Park YG. Current Trends for Treating Lateral Epicondylitis. Clin Shoulder Elb. 2019 Dec 1;22(4):227-234. doi: 10.5397/cise.2019.22.4.227. eCollection 2019 Dec.

  PMID: 33330224 BACKGROUND

• Chen J, Wang A, Xu J, Zheng M. In chronic lateral epicondylitis, apoptosis and autophagic cell death occur in the extensor carpi radialis brevis tendon. J Shoulder Elbow Surg. 2010 Apr;19(3):355-62. doi: 10.1016/j.jse.2009.07.064.

  PMID: 19836974 BACKGROUND

• Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.

  PMID: 24292930 BACKGROUND

• Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 Dec 21.

  PMID: 29268037 BACKGROUND

• Karaduman M, Okkaoglu MC, Sesen H, Taskesen A, Ozdemir M, Altay M. Platelet-rich plasma versus open surgical release in chronic tennis elbow: A retrospective comparative study. J Orthop. 2016 Jan 22;13(1):10-4. doi: 10.1016/j.jor.2015.12.005. eCollection 2016 Mar.

  PMID: 26955228 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Enrico Guerra, MD

  Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Guerra, MD

CONTACT

0516366567; enrico.guerra@ior.it

Roberta Licciardi, MSc

CONTACT

6366567; roberta.licciardi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: They will be "blinded" patients, health professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind randomized controlled clinical trial with 1:1:1 allocation

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: March 23, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

IT (1)