Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06848374

Dose Efficacy in Adhesive Capsulitis

Led by University Health Network, Toronto · Updated on 2025-02-27

40

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Dose Efficacy in Adhesive Capsulitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • Diagnosed with adhesive capsulitis of the shoulder
Not Eligible

You will not qualify if you...

  • Injection received in the affected shoulder within the last 3 months (any kind)
  • History of previous surgery in the affected shoulder
  • Glenohumeral osteoarthritis more than mild on x-ray
  • Pregnancy
  • Use of blood thinners other than Aspirin 80 mg or bleeding disorder
  • Active infection requiring antibiotics
  • Allergy to steroid or lidocaine
  • Cognitive impairment
  • Active litigation
  • Inflammatory connective tissue disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Toronto Rehabilitation Institution

Toronto, Ontario, Canada, M9C 2X8

Actively Recruiting

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Research Team

N

Nimish Mittal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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