About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
PRP injection received more than 48 hours before inclusion
Participation in another clinical study with exclusion period
Adults under legal protection
Pregnant women
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Development of a predictive model for PRP response
Using baseline data to create a model predicting patient response to PRP treatment.
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)
Sponsors and contacts
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