An observational study in Lateral Epicondylitis of the Elbow, sponsored by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape · Observational
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.
296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.
This study's planned enrollment of 139 is above the median of 90 across 29 observational studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 90 days after PRP injection
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.
Time frame: Baseline
Development of a predictive model for PRP response
Using baseline data to create a model predicting patient response to PRP treatment.
Time frame: Baseline (Day 0) to Day 90
Evolution of clinical and functional outcomes
Evolution from inclusion (J0) to J45 and J90 of the following parameters: 1. Pain scores: EVA and DN4 2. Functional status: PRTEE questionnaire and handgrip test 3. Return-to-work status 4. Management and treatments received (e.g., physiotherapy, splint)
Time frame: From baseline (Inclusion, Day 0) to Day 45 and Day 90
Started Aug 2023 (actual). Primary completion is estimated for Aug 2026, 36 months after the start.
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Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape