DEgenerative ROtator Cuff Disease and Botulinum TOXin

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05327972
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Degenerative Rotator Cuff Disease

Eligibility Criteria

Sex
ALL
Age
41 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). — DRUG
    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.
  • PLACEBO — OTHER
    Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.

Study Details

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

Key Dates

Start date
Jan 20, 2023
Status verified
Jun 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1- Botulinum toxin
    The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). The dosage is: 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.
  • Placebo Comparator: 2- PLACEBO
    The placebo comparator represents a saline solution containing an inactive lyophilisate. The dosage is: Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.

Primary Outcome Measure

Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100; [ Time Frame: 1 month ]

Central Contacts