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Clinical Trials in France / NCT07496983
Recruiting Observational

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

NCT07496983 · tracked via the Priya Life Science France tracker
Sponsor
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Phase
Observational
Started
2023-08-04
Last updated
2026-03-27

Condition(s) studied

Lateral Epicondylitis of the Elbow

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Response to PRP treatment — 90 days after PRP injection
    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.

Trial sites (1)

FacilityCityRegionStatus
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape Ploemeur France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07496983 on ClinicalTrials.gov ↗ ← All trials in France