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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1
University of Virginia
Charlottesville, Virginia, United States, 22908