Comparing 40 mg vs 80 mg Methylprednisolone with Hydrodilatation for Treating Adhesive Capsulitis of the Shoulder

What this Trial Is About

Researchers are evaluating the treatment of adhesive capsulitis of the shoulder by comparing two doses of methylprednisolone combined with hydrodilatation. The study aims to determine if 40 mg of methylprednisolone with hydrodilatation is as effective as 80 mg for reducing pain, improving shoulder movement, and minimizing side effects. This phase 3 trial is conducted at the Toronto Rehabilitation Institute and involves random assignment of participants to one of the two dose groups. Participants will receive an ultrasound-guided injection of methylprednisolone into the shoulder using an anterior approach combined with hydrodilatation. The two treatment groups receive either 40 mg or 80 mg of methylprednisolone. This is a double-blind study, so neither the patient nor the physician knows which dose is given. The study is expected to last about 12 months with results available in 15 to 18 months. During the study, participants will have evaluations at baseline before injection, four weeks after, and three months after the procedure. These assessments include pain scores using a Numeric Pain Scale, range of motion measurements, and questionnaires like the Shoulder Pain and Disability Index. Researchers will monitor responses to treatment and track any side effects throughout the study period.

Dose Efficacy in Adhesive Capsulitis