Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis (AES)

Vascular Institute of Virginia

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Frozen Shoulder; Adhesive Capsulitis

Treatments: Device: Arterial Embolization of the Shoulder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03676829

20181853 (Other Identifier)

G180115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate to severe shoulder pain (VAS greater than 40mm), and
• diagnosis of adhesive capsulitis, and
• age > 21, and
• pain refractory to at least 30 days of conservative therapy (pain medications, physical therapy, etc.)

Exclusion criteria

• current local infection, or
• life expectancy less than 6 months, or
• known advanced atherosclerosis, or
• rheumatoid or infectious arthritis, or
• prior shoulder replacement surgery, or
• uncorrectable coagulopathy as defined by INR > 2.5 or platelets < 30,000, or
• iodine allergy resulting in anaphylaxis, or
• renal dysfunction as defined by GRF of < 45, or
• contraindication for magnetic resonance imaging, or
• known complete full thickness tear of rotator cuff, or
• currently pregnant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arterial Embolization of the Shoulder (AES)

Experimental group

Description:

Patients in this study will receive the arterial embolization of the shoulder (AES) procedure. The primary aims will be to determine if arterial embolization of the shoulder (AES) will reduce pain and improve range of motion (ROM) caused by adhesive capsulitis.

Treatment:

Device: Arterial Embolization of the Shoulder