Lateral Epicondylitis of the Elbow
Conditions
Brief 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.
Interventions
None listed
Sponsors
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive factors for response to PRP | 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. |
| Development of a predictive model for PRP response | Baseline (Day 0) to Day 90 | Using baseline data to create a model predicting patient response to PRP treatment. |
| Evolution of clinical and functional outcomes | From baseline (Inclusion, Day 0) to Day 45 and Day 90 | 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) |
Countries
France
Contacts
CONTACTThomas Julienne, MD
Outcome results
None listed