Identification of Responders to Platelet-Rich Plasma (PRP) Injections in Lateral Elbow Epicondylalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lateral Epicondylitis of the Elbow. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Response to PRP treatment [Time frame: 90 days after PRP injection]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape — Ploemeur
Identifiers
NCT: NCT07496983 · 2022-A02311-42