Dose Efficacy in Adhesive Capsulitis

NCT06848374 | Recruiting Phase 3

• 1 other identifier: 24-5123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Frozen shoulder; hydrodilatation

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Scale

  Change in pain scores using Numeric Pain Rating scale form baseline to 3 months

  3 months

Secondary Outcomes (1)

• Shoulder Pain and Disability Index score

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

40mg methylprednisolone dose

Drug: 40 mg Methylprednisolone

Group B

ACTIVE COMPARATOR

80mg methylprednisolone dose

Drug: 80 mg Methylprednisolone

Interventions

40 mg Methylprednisolone DRUG

Ultrasound guided injection of 40mg methylprednisolone injection

Group A

80 mg Methylprednisolone DRUG

Ultrasound guided injection of 40mg methylprednisolone injection

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Diagnostic of adhesive capsulitis of the shoulder

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Rehabilitation Institution

Toronto, Ontario, M9C 2X8, Canada

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Nimish Mittal

CONTACT

416-597-3422; nimish.mittal@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 27, 2025
• Study Start: December 20, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)