Adhesive Capsulitis of the Shoulder
Conditions
Keywords
Frozen shoulder, hydrodilatation
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.
Interventions
DRUG40 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
DRUG80 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Scale | 3 months | Change in pain scores using Numeric Pain Rating scale form baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain and Disability Index score | 3 months | change in pain scores using Shoulder Pain and Disability Index score form baseline to 3 months |
Countries
Canada
Contacts
Primary ContactNimish Mittal
Outcome results
None listed