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Recruiting Phase 3 NCT06848374

Dose Efficacy in Adhesive Capsulitis

◆ AI Clinical Summary

This study tests whether a lower dose of methylprednisolone (40 mg) combined with a shoulder injection procedure works as well as a higher dose (80 mg) for treating frozen shoulder. Researchers will measure how much pain decreases, how much shoulder movement improves, and what side effects occur in each group.

Key Objective: The trial is testing whether a lower steroid dose can be equally effective while potentially causing fewer side effects.

Who to Consider: People with adhesive capsulitis (frozen shoulder) experiencing pain and limited mobility who are interested in steroid and hydrodilatation treatment should consider enrolling.

Trial Parameters

Condition Adhesive Capsulitis of the Shoulder
Sponsor University Health Network, Toronto
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-20
Completion 2026-06-30
Interventions
40 mg Methylprednisolone80 mg Methylprednisolone

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.

Eligibility Criteria

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

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