Dose Efficacy in Adhesive Capsulitis

Recruiting now · Phase 3

Conditions studied: Adhesive Capsulitis of the Shoulder

In brief

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.

Key facts

Study ID

NCT06848374

Run by

University Health Network, Toronto

People needed

40

Starts

2024-12-20

Expected to finish

2026-12-31

Last updated by the study team

2025-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Toronto Rehabilitation Institution — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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