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A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis

NCT03380559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-09-21

No results posted yet for this study

Summary

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.

Conditions

  • Epicondylitis

Interventions

DRUG

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 %)

DRUG

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 %)

DRUG

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 %)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • François Genêt, MD, PhD · Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2021-07-07
Completion
2021-08-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380559 on ClinicalTrials.gov