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NCT Number: NCT07496983

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

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.

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Key information

Conditions

Lateral Epicondylitis of the Elbow

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape

Ploemeur, 56270, France

Location status: Recruiting

Location contact

Thomas Julienne, MD

CONTACT

[email protected]

+33 2 97 82 60 27

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Predictive factors for response to PRP

    Time frame: Baseline

    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.

  2. Development of a predictive model for PRP response

    Time frame: Baseline (Day 0) to Day 90

    Using baseline data to create a model predicting patient response to PRP treatment.

  3. Evolution of clinical and functional outcomes

    Time frame: From baseline (Inclusion, Day 0) to Day 45 and Day 90

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Julienne, MD

CONTACT

[email protected]

+33 2 97 82 60 27

Sponsors and collaborators

Lead sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Other

Registry information

Acronym: EPIC-PRP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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