Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2024-12-20
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
40mg methylprednisolone dose
40 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
Group B
80mg methylprednisolone dose
80 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
Interventions
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40 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
80 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
Eligibility Criteria
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Inclusion Criteria
* Diagnostic of adhesive capsulitis of the shoulder
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Nimish Mittal
Assistant Professor
Locations
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Toronto Rehabilitation Institution
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-5123
Identifier Type: -
Identifier Source: org_study_id
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