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

• Status: Terminated
• Trial end date: 2017-05-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Botulinum Toxins; onabotulinumtoxinA

Criteria

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