Dose Efficacy in Adhesive Capsulitis

February 23, 2025 updated by: Nimish Mittal, University Health Network, Toronto

Dose Comparison for the Treatment of Adhesive Capsulitis with Hydrodilatation and Corticosteroid Using an Anterior Approach Under Ultrasound-Guidance

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M9C 2X8
        • Recruiting
        • Toronto Rehabilitation Institution
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
40mg methylprednisolone dose
Drug: 40 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection
Active Comparator: Group B
80mg methylprednisolone dose
Drug: 80 mg Methylprednisolone
Ultrasound guided injection of 40mg methylprednisolone injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Scale
Time Frame: 3 months
Change in pain scores using Numeric Pain Rating scale form baseline to 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index score
Time Frame: 3 months
change in pain scores using Shoulder Pain and Disability Index score form baseline to 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 8, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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