Clinical trial
A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Name
P160926J
Description
The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.
As secondary objectives, the study aims to
* demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
* evaluate tolerance of treatment by grip strength measurement and adverse event collection.
Trial arms
Trial start
2019-04-19
Estimated PCD
2021-07-07
Trial end
2021-08-19
Status
Completed
Phase
Early phase I
Treatment
Injection, botulinum toxin + corticoid
* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
* Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
Arms:
Group A : Association (botulinum toxin + corticoid)
Injection, placebo of toxin + corticoid
* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
* Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
Arms:
Group C : placebo of toxin + corticoid :
Injection, botulinum toxin + placebo corticoid
* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
* Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)
Arms:
Group T : botulinum toxin + placebo corticoid
Size
33
Primary endpoint
Variation of pain intensity between injection of treatment and 6 months after injection
At the moment of injection
Variation of pain intensity between injection of treatment and 6 months after injection
6 months after injection
Eligibility criteria
Inclusion Criteria:
* Patient aged between 18 and 60 years;
* Physical disability or not;
* Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;
* Signed consent obtained;
* Covered by health insurance.
Exclusion Criteria:
* Central nervous system disorders result in spasticity in epicondylitis limb;
* History of severe psychiatric disorder;
* History of myasthenia gravis;
* Pregnant or breastfeeding woman;
* Unable to understand or respond to questions;
* Contraindication to botulinum toxin or corticoid;
* Treatment with botulinum toxin 3 months prior to baseline;
* Anticoagulant theraphy;
* Difficult to follow-up in the study;
* Patient under guardianship, or deprived of liberty by a judicial order.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ratio 1:1:1', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}
Updated at
2023-09-21
1 organization
3 products
1 indication
Organization
Assistance Publique - Hôpitaux de ParisProduct
Botulinum Toxin + CorticoidIndication
EpicondylitisProduct
InjectionProduct
Botulinum Toxin