NCT03676829

Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vascular Institute of Virginia · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Frozen Shoulder
• Adhesive Capsulitis

Interventions

Type	Name	Description
DEVICE	Arterial Embolization of the Shoulder	Arterial Embolization of the Shoulder (AES) is a new procedure that is being used to reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the shoulder, resulting in improvement of pain, stiffness and from adhesive capsulitis.

Timeline

• Start date: 2018-09-13
• Primary completion: 2019-08-01
• Completion: 2019-12-01
• First posted: 2018-09-19
• Last updated: 2018-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study