Recruiting
Phase 3

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06848374

Conditions

Adhesive Capsulitis of the Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

40 mg Methylprednisolone

80 mg Methylprednisolone

Study Details

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.

Conditions

Adhesive Capsulitis of the Shoulder

Study ID

NCT06848374

Start date

Dec 20, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A

40mg methylprednisolone dose

active comparator: Group B

80mg methylprednisolone dose

Interventions

40 mg Methylprednisolone

Ultrasound guided injection of 40mg methylprednisolone injection

80 mg Methylprednisolone

Ultrasound guided injection of 40mg methylprednisolone injection

Primary outcome measure

  • Numeric Pain Scale [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Toronto Rehabilitation Institution

Recruiting

Toronto, Ontario, Canada, M9C 2X8

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 27, 2025

Last verified

Feb, 2025

Keywords

  • Frozen shoulder
  • hydrodilatation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-02-27.