Dose Efficacy in Adhesive Capsulitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 40 mg Methylprednisolone, 80 mg Methylprednisolone.
- Who it may be relevant to
- Registry conditions: Adhesive Capsulitis of the Shoulder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dose Comparison for the Treatment of Adhesive Capsulitis with Hydrodilatation and Corticosteroid Using an Anterior Approach Under Ultrasound-Guidance
Overview
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
- Drug 40 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection - Drug 80 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
Primary outcome measures
- Numeric Pain Scale [Time frame: 3 months]
Secondary outcome measures (1)
- Shoulder Pain and Disability Index score [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Toronto Rehabilitation Institution — Toronto
Identifiers
NCT: NCT06848374 · 24-5123