Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia (NCT02325063) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia
Stopped: Discontinuation of production of the investigational medicinal product (PRP)
France13 participantsStarted 2015-12-17
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
What they're measuring
1
Visual analog scale (VAS) for pain over the last 24 hours