Dose Efficacy in Adhesive Capsulitis

University Health Network, Toronto

Status and phase: Enrolling; Phase 3

Conditions: Adhesive Capsulitis of the Shoulder

Treatments: Drug: 80 mg Methylprednisolone; Drug: 40 mg Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06848374

24-5123

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Group A

Active Comparator group

Description:

40mg methylprednisolone dose

Treatment:

Drug: 40 mg Methylprednisolone

Group B

Active Comparator group

Description:

80mg methylprednisolone dose

Treatment:

Drug: 80 mg Methylprednisolone