Lateral Epicondylitis of the ElbowEPIC-PRPNCT07496983
Identification of Responders to Platelet-Rich Plasma (PRP) Injections in Lateral Elbow Epicondylalgia
An observational study of Lateral Epicondylitis of the Elbow, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis of the Elbow
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2023to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- PRP injection received more than 48 hours before inclusion
- Participation in another clinical study with exclusion period
- Adults under legal protection
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
Ploemeur, 56270
Thomas Julienne, MD, +33 2 97 82 60 27, thomas.julienne@vyv3.fr
About this study
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:
Read more
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.
- Conditions
- Lateral Epicondylitis of the Elbow
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after PRP injection
Secondary outcomes (3)
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.
Measured: Baseline
Development of a predictive model for PRP response
Using baseline data to create a model predicting patient response to PRP treatment.
Measured: 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)
Measured: From baseline (Inclusion, Day 0) to Day 45 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start4 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis of the ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496983
- Sponsor's protocol ID
- 2022-A02311-42
- Acronym
- EPIC-PRP
- Status last verified
- Nov 2025
- First submitted
- 18 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Responders to Platelet-Rich Plasma (PRP) Injections in Lateral Elbow Epicondylalgia
- ClinicalTrials.gov ID
- NCT07496983
- Acronym / sponsor ID
- EPIC-PRP / 2022-A02311-42
- Conditions
- Lateral Epicondylitis of the Elbow
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- PRP injection received more than 48 hours before inclusion
- Participation in another clinical study with exclusion period
- Adults under legal protection
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response to PRP treatment
Time frame: 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.
3 secondary outcomes
Predictive factors for response to PRP
Time frame: Baseline
Development of a predictive model for PRP response
Time frame: Baseline (Day 0) to Day 90
Evolution of clinical and functional outcomes
Time frame: From baseline (Inclusion, Day 0) to Day 45 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Related trials for Lateral Epicondylitis of the Elbow
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruiting
Efficacy and Safety of Selected Traditional Chinese Medicine Elbow Manipulation Versus Mill's Manipulation as Control for Lateral Epicondylitis
To Evaluate the Efficacy and Safety of Selected TCM Elbow Manipulation in Treating, Lateral Epicondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis of the Elbow, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Julienne, MD (+33 2 97 82 60 27, thomas.julienne@vyv3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to PRP treatment (time frame: 90 days after PRP injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.