Dose Efficacy in Adhesive Capsulitis

Phase 3

Recruiting

• Conditions: Adhesive Capsulitis of the Shoulder
• Interventions: Drug: 40 mg Methylprednisolone; Drug: 80 mg Methylprednisolone

• Registration Number: NCT06848374
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-20
• Status Verified: 2025-02
• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-23
• Last Update Submitted: 2025-02-23
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• >18 years of age
• Diagnostic of adhesive capsulitis of the shoulder

Exclusion Criteria

• Injection received in the affected shoulder < 3 months ago (any kind)
• History of previous surgery in the affected shoulder
• Glenohumeral osteoarthritis more than mild on the xray
• Pregnancy
• Blood thinner (other than Aspirin 80 mg) or bleeding disorder
• Active infection (requiring antibiotic)
• Allergy to steroid or lidocaine
• Cognitive impairment
• Active litigation
• Inflammatory connective tissue disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	40 mg Methylprednisolone	40mg methylprednisolone dose
Group B	80 mg Methylprednisolone	80mg methylprednisolone dose

Primary Outcome Measures

Name	Time	Method
Numeric Pain Scale	3 months	Change in pain scores using Numeric Pain Rating scale form baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index score	3 months	change in pain scores using Shoulder Pain and Disability Index score form baseline to 3 months

Trial Locations

Locations (1)

Toronto Rehabilitation Institution; 🇨🇦 Toronto, Ontario, Canada