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Corticosteroid

ZILRETTA™ for Frozen Shoulder

Phase 1
Waitlist Available
Led By Brian Werner, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after injection
Awards & highlights

Study Summary

This trial is testing a new pain medication for people with a common condition that causes pain and loss of range of motion.

Who is the study for?
This trial is for individuals with idiopathic adhesive capsulitis, also known as frozen shoulder, experiencing pain of at least 5 out of 10 on the pain scale. Participants must have had symptoms for less than six months and be able to attend follow-up visits over a year. It's not suitable for those with active workers' compensation cases, uncontrolled diabetes, certain psychiatric disorders under treatment, or diagnosed osteoarthritis in either shoulder.Check my eligibility
What is being tested?
The study tests ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension) given as an injection into the shoulder joint. The goal is to reduce inflammation and improve pain and mobility in patients with frozen shoulder. Progress will be monitored through four check-ups within one year after receiving the injection.See study design
What are the potential side effects?
Possible side effects from ZILRETTA™ may include discomfort at the injection site, increased risk of infection due to immune suppression by steroids, elevation of blood sugar levels especially in diabetics, temporary facial flushing, insomnia or mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analog Scale Score
Secondary outcome measures
American Shoulder and Elbow Society Score
Need for another injection
PROMIS Physical Function Score
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZILRETTAExperimental Treatment1 Intervention
Single injection of triamcinolone acetonide extended-release injectable suspension, injected in the glenohumeral joint under ultrasound guidance.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,981 Total Patients Enrolled
Brian Werner, MDPrincipal Investigator - University of Virginia
UVA-HealthSouth Rehabilitation Hospital
1 Previous Clinical Trials
260 Total Patients Enrolled

Media Library

triamcinolone acetonide extended-release injectable suspension (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04831255 — Phase 1
Adhesive Capsulitis Research Study Groups: ZILRETTA
Adhesive Capsulitis Clinical Trial 2023: triamcinolone acetonide extended-release injectable suspension Highlights & Side Effects. Trial Name: NCT04831255 — Phase 1
triamcinolone acetonide extended-release injectable suspension (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04831255 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is triamcinolone acetonide extended-release injectable suspension typically utilized therapeutically?

"Triamcinolone acetonide extended-release injectable suspension is a viable medical solution to treat ulcerative colitis, hand ailments and neurological conditions."

Answered by AI

Are there any other research projects that have investigated triamcinolone acetonide extended-release injectable suspension?

"Currently, 41 clinical trials are studying triamcinolone acetonide extended-release injectable suspension. Out of these active studies, 8 have attained Phase 3 status. Although the majority of research for this medication is conducted in Columbia, Missouri, there are 75 medical centres conducting related experiments."

Answered by AI

What is the current magnitude of research participants in this trial?

"Affirmative. According to the clinicaltrials.gov platform, this clinical trial is actively enrolling subjects and was first posted on June 21st 2019 with its most recent revision dating back to April 5th 2021. The research aims to recruit 50 participants from a single site."

Answered by AI

Is the age limit for joining this clinical trial higher than thirty years?

"This clinical trial allows applicants aged 18-80 to join the study. Additionally, there are 6 studies designed specifically for those younger than 18 and 60 more tailored towards seniors above 65 years of age."

Answered by AI

Are there any open slots left in this research trial?

"Clinicaltrials.gov assesses that this medical investigation is actively recruiting patients, having been posted on June 21st 2019 and recently updated on April 5th 2021."

Answered by AI

Is it safe to administer triamcinolone acetonide extended-release injectable suspension on humans?

"As it is only a Phase 1 trial, with limited evidence regarding efficacy and safety, triamcinolone acetonide extended-release injectable suspension received an overall score of one."

Answered by AI

May I register for the trial?

"This medical experiment is seeking 50 individuals aged 18-80 that have recently developed adhesive capsulitis of the shoulder, accompanied by a degree of pain rated 5/10 or higher. These potential participants must also be amenable to return for follow up evaluations at 1 month, 3 months, 6 months and 12 months after receiving the injection."

Answered by AI
~9 spots leftby Apr 2025