Identification of Responders to Platelet-Rich Plasma (PRP) Injections in Lateral Elbow Epicondylalgia (EPIC-PRP)

The goal of this non-interventional study is to identify patients who respond to platelet-rich plasma (PRP) injections for chronic lateral epicondylalgia (tennis elbow) and to investigate factors associated with treatment response. The study will include approximately 139 adults (18 years and older) with chronic lateral elbow pain who received a PRP injection within the last 48 hours.

The main question it aims to answer is:

How many patients respond to PRP treatment for chronic lateral epicondylalgia at 90 days after injection?

Secondary questions include:

Which clinical, demographic, and occupational factors are associated with response to PRP?

Can a predictive model be developed to identify patients likely to respond to PRP?

How do pain, hand grip strength, and functional outcomes evolve over 90 days in responders versus non-responders?

Participants will:

Attend three visits at baseline (Day 0), Day 45, and Day 90.

Undergo clinical examinations, pain assessments (EVA, DN4), functional tests (hand grip, PRTEE), and questionnaires.

Have data on professional activities, medical history, and treatments collected.

All procedures are part of routine care, except for the addition of the Clinical Global Impression - Change (CGI-C) scale at Day 45 and Day 90 to assess treatment response.

The study will be conducted at the CMRRF de Kerpape and the CHU de Rennes in France. Each participant will be followed for approximately 3 months.

Study Overview

• Status: Recruiting
• Conditions: Lateral Epicondylitis of the Elbow

• Study Type: Observational
• Enrollment (Estimated): 139

Contacts and Locations

• Study Contact: Name: Thomas Julienne, MD; Phone Number: +33 2 97 82 60 27; Email: thomas.julienne@vyv3.fr

Study Locations

• France
  • Ploemeur, France, 56270
    • Recruiting
    • Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
    • Contact: Thomas Julienne, MD; Phone Number: +33 2 97 82 60 27; Email: thomas.julienne@vyv3.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with chronic lateral epicondylalgia (tennis elbow) confirmed clinically or by imaging, who received a platelet-rich plasma (PRP) injection within the previous 48 hours at participating centers in France. Patients must be medically stable and able to provide informed consent.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Chronic lateral epicondylalgia (tennis elbow), diagnosed clinically or by imaging (ultrasound or MRI), evolving for more than 3 months
• PRP injection received within the last 48 hours
• Medically stable
• Able to provide informed consent/non-opposition
• Affiliation to a social security system

Exclusion Criteria:

• PRP injection received more than 48 hours before inclusion
• Participation in another clinical study with exclusion period
• Adults under legal protection
• Pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to PRP treatment	Patient response is classified as responder or non-responder based on medical assessment, clinical evolution (pain, functional tests such as PRTEE, handgrip, EVA, DN4), and the Clinical Global Impression - Change (CGI-C) scale. Scores 1-3 indicate responder; 4-7 indicate non-responder.	90 days after PRP injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factors for response to PRP	Factors include age, sex, socioeconomic status, medical history (diabetes, smoking, periodontal disease), neuropathic pain, tendon features (fissures, calcifications), previous treatments, occupational and extra-professional activities, affected arm (dominant/non-dominant), symptom duration, and recognition as occupational disease.	Baseline
Development of a predictive model for PRP response	Using baseline data to create a model predicting patient response to PRP treatment.	Baseline (Day 0) to Day 90
Evolution of clinical and functional outcomes	Evolution from inclusion (J0) to J45 and J90 of the following parameters: Pain scores: EVA and DN4; Functional status: PRTEE questionnaire and handgrip test; Return-to-work status; Management and treatments received (e.g., physiotherapy, splint)	From baseline (Inclusion, Day 0) to Day 45 and Day 90

Collaborators and Investigators

• Sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A02311-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No