RecruitingPhase 3NCT06848374

Dose Efficacy in Adhesive Capsulitis

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


Sponsor

University Health Network, Toronto

Enrollment

40 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria10

  • 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

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Interventions

DRUG40 mg Methylprednisolone

Ultrasound guided injection of 40mg methylprednisolone injection

DRUG80 mg Methylprednisolone

Ultrasound guided injection of 40mg methylprednisolone injection


Locations(1)

Toronto Rehabilitation Institution

Toronto, Ontario, Canada

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NCT06848374


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