Dose Efficacy in Adhesive Capsulitis

ConditionAdhesive Capsulitis of the Shoulder

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years of age

Diagnostic of adhesive capsulitis of the shoulder

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

40 mg Methylprednisolone
Drug
Ultrasound guided injection of 40mg methylprednisolone injection
80 mg Methylprednisolone
Drug
Ultrasound guided injection of 40mg methylprednisolone injection

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Group AActive comparator 1 intervention

Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

Numeric Pain Scale

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

Time frame

3 months

Secondary outcomes

Shoulder Pain and Disability Index score

change in pain scores using Shoulder Pain and Disability Index score form baseline to 3 months

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

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