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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days after PRP injection

Secondary outcomes

1

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.

Time frame
Baseline
2

Development of a predictive model for PRP response

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

Time frame
Baseline (Day 0) to Day 90
3

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)

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

Other outcomes

Sponsors and contacts

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