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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 40mg methylprednisolone dose |
|
| Group B | Active Comparator | 80mg methylprednisolone dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40 mg Methylprednisolone | Drug | Ultrasound guided injection of 40mg methylprednisolone injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Scale | Change in pain scores using Numeric Pain Rating scale form baseline to 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain and Disability Index score | change in pain scores using Shoulder Pain and Disability Index score form baseline to 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nimish Mittal | Contact | 416-597-3422 | nimish.mittal@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehabilitation Institution | Recruiting | Toronto | Ontario | M9C 2X8 | Canada |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| 80 mg Methylprednisolone |
| Drug |
Ultrasound guided injection of 40mg methylprednisolone injection |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |