Dose Efficacy in Adhesive Capsulitis

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Dose Efficacy in Adhesive Capsulitis," is studying how effective two different doses of a medication called methylprednisolone, combined with a treatment called hydrodilatation, are for people with adhesive capsulitis, also known as frozen shoulder. Specifically, the researchers want to see if a lower dose of 40 mg works just as well as a higher dose of 80 mg in reducing pain and improving shoulder movement. The trial is taking place at the Toronto Rehabilitation Institute and will include 40 participants over the age of 18 who have been diagnosed with adhesive capsulitis.

If you decide to participate, you will have your shoulder treated with hydrodilatation, which involves using ultrasound to guide the injection of the medication. This trial is "double-blind," meaning that neither you nor the doctors will know which dose you are receiving, helping to ensure unbiased results. Throughout the study, you will fill out questionnaires and have your pain and shoulder movement measured at the start, four weeks later, and again three months after the treatment. The study is expected to last about 12 months, with results available in 15 to 18 months. It’s important to note that certain conditions, like recent shoulder injections, previous shoulder surgeries, or active infections, may prevent you from participating.

Gender

ALL

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