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Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis — AES  

Adhesive Capsulitis Clinical Trial

Official title:
Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

Clinical Trial Summary

This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely.

Clinical Trial Description

Purpose: The primary aims of this study are to determine if arterial embolization of the shoulder will reduce the severity of pain as well improve Range of Motion (ROM) caused by adhesive capsulitis and if it can be performed safely. The secondary aim is to determine if AES can result in the decreased necessity for ongoing conservative therapies, such as medication therapy and joint injections.

Participants: Twenty patients with adhesive capsulitis, resulting in shoulder pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.

Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing AES to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for arterial embolization of the shoulder, and follow-up visits at 24 hours, 1, 3 & 6 months. An MRI will be performed at the 1-month visit to detect a change in capsular vascularity and to exclude complication. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03676829
Study type Interventional
Source Vascular Institute of Virginia
Contact Julie Orlando, CCRC
Phone 703-763-5224
Email jorlando@teamviv.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 13, 2018
Completion date December 2019
View Details
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