ZILRETTA™ for Treatment of Idiopathic Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

A Stratified Investigation of a Single Injection of ZILRETTA™ (Triamcinolone Acetonide Extended-release Injectable Suspension) for Symptomatic Relief in Patients With Idiopathic Adhesive Capsulitis of the Shoulder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831255
• Other study ID #: 21584
• Status: Recruiting
• Phase: Phase 1
• Start date: June 21, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2021
• Source: University of Virginia
• Contact: Kaitlyn Shank, MEd, ATC
• Phone: 434-243-5653
• Email: kshank[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 steroid injection. This is done to help decrease the inflammatory response caused by adhesive capsulitis. In this study, all participants will receive an intra-articular glenohumeral injection of ZILRETTA and will be followed up with at four time points over 1 year to observe pain, function and range of motion following the injection.

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 shoulder joint capsule. It occurs in about 2% to 5% of the population, and a majority of patients are female. The true cause of the condition remains unclear, however, it has been proposed that the initial synovitis stimulates the development of a fibrotic cascade. The development of adhesive capsulitis has been associated with diabetes mellitus, thyroid dysfunction, Dupuytrens contractures, autoimmune diseases and treatments for certain cancers. Adhesive capsulitis progresses through four predictable phases, defined by symptoms, physical examination, arthroscopic appearance and biopsies.

Regardless of stage, the mainstay of treatment for adhesive capsulitis of the shoulder is conservative, focused mainly on physical therapy combined with a home exercise program, regardless of stage. Pharmacologic agents are often used as adjuncts to physical therapy, and include nonsteroidal anti-inflammatory medications (NSAIDs), oral corticosteroids and intra-articular injections of corticosteroids. Although a large percentage of patients in the early stages of disease respond well to conservative treatments, those who fail therapy and injections may require surgical intervention, including arthroscopy with lysis of adhesions and/or manipulation under anesthesia.

Numerous studies have investigated the effect and success of injections combined with standard physical therapy for adhesive capsulitis of the shoulder. In general, intra-articular injection of corticosteroids has been found to be superior to administration of oral cortisone and at least equivalent to manipulation under anesthesia alone. Injections have been shown to reduce pain quicker and result in earlier return of range of motion. Low doses of steroid appear equally as effective as higher doses. Image-guided injections, whether ultrasound or fluoroscopic guided injections, have also been shown to be more effective than blinded injections.

Failure of an injection and therapy to provide relief either results in a repeat image-guided injection or surgical intervention, both of which have significant associated cost and potential morbidity. Thus, there would be significant potential value to a long-acting, sustained release intra-articular steroid injection for the treatment of adhesive capsulitis of the shoulder. Zilretta®, triamcinolone acetonide extended release suspension 32 mg, is a microsphere formulation of injectable steroid which is FDA-approved for and has shown significant promise for the treatment of knee osteoarthritis. This long-acting steroid could have several important advantages in the treatment of shoulder adhesive capsulitis. It may potentiate and prolong the anti-inflammatory effect of the steroid, and potentially avoid the need for costly additional image-guided injections or expensive and potentially morbid surgery. An additional potential benefit is less elevation of peripheral blood glucose in diabetics, a known complication of traditional steroid injections that has been demonstrated to be mitigated using a sustained release formulation.

Out primary aim in this study is to assess patient reported pain and outcomes in patients with idiopathic adhesive capsulitis of the shoulder at 3, 6 and 12 months following single, image guided ZILRETTA injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Adhesive Capsulitis of Shoulder
• Bursitis
• Frozen Shoulder

Intervention

Drug:
• triamcinolone acetonide extended-release injectable suspension
ZILRETTA (triamcinolone acetonide extended-release injectable suspension) injection in the glenohumeral joint administered under ultrasound guidance.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale Score	Pain rating on a scale of 0-10, higher numbers indicating a worse outcome	6 months after injection
Secondary	American Shoulder and Elbow Society Score	Pain and function patient reported outcome for the shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.	6 months after injection
Secondary	American Shoulder and Elbow Society Score	Pain and function patient reported outcome for the shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.	12 months after injection
Secondary	PROMIS Physical Function Score	Patient reported outcome measuring physical function level measured by T scores and standard deviations. The average is 50, so a T score lower than 50 indicates a worse outcome.	6 months after injection
Secondary	PROMIS Physical Function Score	Patient reported outcome measuring physical function level measured by T scores and standard deviations. The average is 50, so a T score lower than 50 indicates a worse outcome.	12 months after injection
Secondary	Triplanar Range of Motion	Shoulder range of motion	1 month after injection
Secondary	Triplanar Range of Motion	Shoulder range of motion	3 months after injection
Secondary	Triplanar Range of Motion	Shoulder range of motion	6 months after injection
Secondary	Triplanar Range of Motion	Shoulder range of motion	12 months after injection
Secondary	Need for another injection	Yes or no answer if the patient needed another corticosteroid injection during their time enrolled in the study	12 months after injection
Secondary	Time to second injection (if applicable)	how long after the ZILRETTA injection the patient needed another corticosteroid injection	12 months after injection