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RECRUITING
NCT05327972
PHASE2

DEgenerative ROtator Cuff Disease and Botulinum TOXin

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.

Official title: DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial

Key Details

Gender

All

Age Range

41 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-01-20

Completion Date

2027-02

Last Updated

2025-06-27

Healthy Volunteers

No

Interventions

DRUG

The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).

Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.

OTHER

PLACEBO

Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.

Locations (1)

Hôpital LARIBOISIERE

Paris, Paris, France