NCT02325063.

Study name	Leukocyte and platelet rich plasma versus type A botulinum toxin versus glucocorticoids for the treatment of lateral epicondylalgia
Methods	Multi‐centre double‐blind parallel 3‐arm randomised controlled trial
Participants	Inclusion criteria Must have given free and informed consent and signed the consent Must be affiliated with or beneficiary to a health insurance plan Available for 6 months of follow‐up Woman of childbearing age using contraception Side epicondylalgia objectified by: Clinical criteria: symptoms lasting longer than 6 weeks and less than 12 months. List of symptoms to be present includes pain on palpation of the lateral epicondyle, pain in the lateral epicondyle during blocked contraction Therapeutic criteria: fewer than 2 injections of glucocorticoid performed; last such injection was performed at least 3 months before inclusion Exclusion criteria Participating in another study Exclusion period determined by a previous study Under judicial protection Under guardianship or curatorship Refuses to sign the consent Woman of childbearing age not using contraception Impossible to correctly inform the patient about the study Non‐inclusion criteria for investigational and auxiliary medicinal products At least 1 of the contraindications 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) Generalised disorder of muscle activity (e.g. myasthenia gravis, Lambert‐Eaton syndrome) Severe coagulation disorder, anticoagulation in progress (ticlopidine, clopidogrel, other antiplatelet or antithrombotic agent) Presence of local or general infection, suspected infection, infection at proposed injection site Non‐inclusion criteria for the medical device used for PRP samples (SmartPReP2 sampling system) Clinical or laboratory evidence for sepsis Taking aspirin or other drugs altering platelet function in the previous 3 days Platelet dysfunction disorder Non‐inclusion criteria for interfering disease or condition Pregnant, parturient, or breastfeeding Allergy to botulinum toxin type A and/or glucocorticoid Medial epicondylalgia History of elbow surgery 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) Received treatment with glucocorticoid in the last 3 months Treated with long‐term antiplatelet medication
Interventions	PRP‐L injection Patients randomised to this group will be treated with an injection of leukocyte and platelet‐rich plasma (PRP‐L) Botox injection Patients randomised to this group will be treated with an injection of type A botulinum toxin (Xeomin®, MERZ) Corticoid injection Patients randomised to this group will be treated with an injection of corticoid
Outcomes	Outcomes are measured at 3 weeks, 6 weeks, 3 months, and 6 months Primary outcome Visual analogue scale (VAS) score for pain over the last 24 hours at 6 months Secondary outcomes VAS score for pain over last 24 hours at 3 weeks, 6 weeks, and 3 months Global efficacy ‐ defined as proportion of patients for whom a decrease in visual analogue scale scores for pain over last 24 hours of at least 25% has been observed over past 6 months VAS for pain after a Jamar grip test at 3 months and 6 months PRTEE scores at 3 months and 6 months Patient Global Impression of Change (score 1 to 7) at 3 months and 6 months SF‐12 at 3 months and 6 months Adverse events
Starting date	17/12/2015
Contact information	Matthieu Vaucher, MD, Centre Hospitalier Universitaire de Nîmes, France
Notes	Recruitment has been terminated