Comparing two doses of corticosteroids for frozen shoulder treatment
Dose Comparison for the Treatment of Adhesive Capsulitis with Hydrodilatation and Corticosteroid Using an Anterior Approach Under Ultrasound-Guidance
PHASE3 · University Health Network, Toronto · NCT06848374
This study is testing whether two different doses of a steroid injection can help people with frozen shoulder feel less pain and move their shoulder better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06848374 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of two different doses of methylprednisolone (40 mg vs 80 mg) combined with hydrodilatation in treating adhesive capsulitis of the shoulder. The study will enroll 40 participants who will be randomly assigned to receive one of the two doses during an ultrasound-guided procedure. Pain reduction, shoulder mobility improvement, and side effects will be assessed through various questionnaires and measurements at baseline and four weeks post-treatment. The trial is designed as a double-blind study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with adhesive capsulitis of the shoulder.
Not a fit: Patients who have received an injection in the affected shoulder within the last three months or have a history of shoulder surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal corticosteroid dosing for improved pain relief and mobility in patients with frozen shoulder.
How similar studies have performed: Previous studies have shown varying success with corticosteroid treatments for adhesive capsulitis, but this specific dose comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Toronto Rehabilitation Institution — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Nimish Mittal
- Email: nimish.mittal@uhn.ca
- Phone: 416-597-3422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adhesive Capsulitis of the Shoulder, Frozen shoulder, hydrodilatation