Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia

Study Overview
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Brief Summary
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The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.

Detailed Description
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The secondary objectives are to compare the following among the three groups: A- The global efficacy of each treatment defined by a minimum reduction of 25% in average pain over the last 24 hours between 0 and 6 months. B- The evolution of average pain over the last 24 hours between 0 and each different time frame (3 weeks, 6 weeks, 3 months and 6 months). C- The evolution of maximum pain scores using nocturnal post-effort (Jamar grip test) visual analog scales (VAS) between day 0, 3 weeks, 6 weeks, 3 months and 6 months. D- The perception of change on the Patient's Global Impression of Change score (PGIC) at 3 and 6 months E- The evolution of PRTEE scores at 0, 3 and 6 months F- Adverse events at 3 weeks, 6 weeks, 3 months and 6 months. G - Quality of life and utility via the SF-12 at 3 and 6 months. H- The consumption of analgesics.

Official Title
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Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms

Conditions
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Epicondylitis, Lateral Humeral, Tennis Elbow

Intervention / Treatment
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* Drug: PRP-L Injection
* Drug: Botox injection
* Drug: Corticoid injection


Participation Criteria
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Eligibility Criteria
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General inclusion criteria: The patient must have given free and informed consent and signed the consent The patient must be affiliated or beneficiary to a health insurance plan The patient is available for 6 months of follow-up Woman of childbearing age using contraception Inclusion criteria for the target population: the patient has a side epicondylalgia objectified by: Clinical criteria: symptoms lasting for more than 6 weeks and less than 12 months. The list of symptoms to be present are: pain on palpation of the lateral epicondyle, pain in the lateral epicondyle during blocked contraction Therapeutic: less than two injections of corticosteroids performed, and the last such injection was performed at least 3 months before inclusion General non-inclusion criteria: The patient is participating in another study The patient is exclusion period determined by a previous study The patient is under judicial protection The patient is under guardianship or curatorship The patient refuses to sign the consent Woman of childbearing age not using contraception Impossible to correction inform the patient about the study Non-inclusion criteria for investigational and auxiliary medicinal products: The patient has at least one of the contra-indications listed in the SPC for Xeomin and ALTIM: Hypersensitivity to Botulinum neurotoxin type A or Cortivazol Hypersensitivity to any of the excipients used in the composition of XEOMIN (Human albumin, sucrose) and / or ALTIM (Benzyl alcohol, carmellose sodium, sodium chloride, cetylpyridinium chloride, polysorbate 80) Generalized disorders of muscle activity (eg myasthenia gravis, Lambert-Eaton syndrome). Severe coagulation disorders, anticoagulation in progress (ticlopidine, clopidogrel, other antiplatelet or antithrombotic agents) Presence of a local or general infection, suspected infection, infection at the proposed injection site. Non-inclusion criteria for the medical device used for the PRP samples (SmartPReP2 sampling system): Clinical or laboratory evidence for sepsis Taking aspirin or other drugs altering platelet function in the previous 3 days Patient with the platelet dysfunction disorders Non-inclusion criteria for interfering diseases or conditions: The patient is pregnant, parturient or she is breastfeeding The patient has an allergy to botulinum toxin type A and / or glucocorticoids The patient has medial epicondylalgia The patient has a history of elbow surgery The patient has any of the following conditions: immunodeficiency, rheumatic disease, hepatitis, diabetes, another disease of the ipsilateral limb, neurological disorder (radiculopathy, compression of the radial nerve), any myopathy (all etiologies) The patient received treatment with corticosteroids in the last 3 months The patient is being treated with long-term anti-platelet medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP-L Group<br>Patients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L). Intervention: PRP-L Injection | Drug: PRP-L Injection<br>* Patients will be treated with an injection of leukocyte and platelet rich plasma.<br>|
| Active Comparator: Botox Group<br>Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ). Intervention: Botox injection | Drug: Botox injection<br>* Patients will be treated with an injection of Type A Botulinum toxin.<br>* Other names: Xeomin®, MERZ;|
| Active Comparator: Corticoid Group<br>Patients randomized to this group will be treated with an injection of Corticoids. Intervention: Corticoid injection | Drug: Corticoid injection<br>* Patients will be treated with an injection of Corticoids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) for pain over the last 24 hours | score varying from 0 to 10 | 6 months versus Baseline (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | Baseline (day 0) | 
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | 3 weeks | 
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | 6 weeks | 
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | 3 months |