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NCT Number: NCT06848374

Dose Efficacy in Adhesive Capsulitis

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.

Recruiting

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Key information

Conditions

Adhesive Capsulitis of the Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto Rehabilitation Institution

Toronto, Ontario, M9C 2X8, Canada

Location status: Recruiting

Location contact

Nimish Mitta;

CONTACT

[email protected]

416-597-3422

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40 mg Methylprednisolone

Drug

Ultrasound guided injection of 40mg methylprednisolone injection

80 mg Methylprednisolone

Drug

Ultrasound guided injection of 40mg methylprednisolone injection

Primary outcomes

  1. Numeric Pain Scale

    Time frame: 3 months

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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nimish Mittal

CONTACT

[email protected]

416-597-3422

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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