Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

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.

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