NCT06848374

Dose Efficacy in Adhesive Capsulitis

Dose Comparison for the Treatment of Adhesive Capsulitis with Hydrodilatation and Corticosteroid Using an Anterior Approach Under Ultrasound-Guidance

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if the treatment of adhesive capsulitis with 40 mg of methylprednisolone in combination with a hydrodilatation is comparable to 80 mg of methylprednisolone for pain reduction, improving shoulder mobility, and reducing side effects. Researchers will enroll 40 people in this study which is taking place solely at the Toronto Rehabilitation Institute, University Avenue. This study should take approximately 12 months to complete and the results should be known in about 15 to 18 months. During this study, patients will receive an ultrasound guided shoulder hydrodilatation combined with corticosteroid after "randomized" into one of the groups (40 mg vs 80 mg). This is a double blind study as both patients and physicians would not know the group patient was randomized to. Pain scores, Range of Motion and few other questionnaires wold be completed to track the response to the interventions at baseline prior to injection, four weeks after the procedure and 3 months after the procedure.

Conditions

• Adhesive Capsulitis of the Shoulder

Interventions

Type	Name	Description
DRUG	40 mg Methylprednisolone	Ultrasound guided injection of 40mg methylprednisolone injection
DRUG	80 mg Methylprednisolone	Ultrasound guided injection of 40mg methylprednisolone injection

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: Canada