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