Status:

TERMINATED

ZILRETTA™ for Treatment of Idiopathic Adhesive Capsulitis

Lead Sponsor:

University of Virginia

Conditions:

Adhesive Capsulitis

Frozen Shoulder

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

Brief Summary

Adhesive capsulitis is a fairly common orthopedic condition that causes pain and loss of range of motion. There are a variety of ways to treat adhesive capsulitis, one of them being an intra-articular...

Detailed Description

Adhesive capsulitis is a painful shoulder condition characterized by a gradual loss of both passive and active range of motion due to inflammatory changes and eventual fibrosis and contracture of the ...

Eligibility Criteria

Inclusion

  • Diagnosis of idiopathic adhesive capsulitis (onset \<6 months prior)
  • Pain rating of 5 or greater out of 10 on 0-10 scale at time of enrollment
  • Willing to come on site for follow up evaluations at 1 month, 3 months, 6 months, and 12 months after the injection

Exclusion

  • Active workers compensation case
  • Known psychiatric disorders under active treatment
  • Uncontrolled diabetes (defined as diabetic ketoacidosis, severe peripheral neuropathy, ophthalmologic or renal manifestations)
  • Diagnosed osteoarthritis of the ipsilateral or contralateral shoulder
  • Painful joint condition in another part of the body affecting perceived pain

Key Trial Info

Start Date :

June 21 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 31 2023

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT04831255

Start Date

June 21 2019

End Date

August 31 2023

Last Update

May 13 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Virginia

Charlottesville, Virginia, United States, 22908