Clinical trial NCT03676829: Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis
Official title: Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Frozen Shoulder
Adhesive Capsulitis
Lead sponsor: Vascular Institute of Virginia
Sponsor class: OTHER
Collaborators: name: Terumo Medical Corporation
First posted: 2018-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Pain
timeFrame: 6 months
measure: Patient Function
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in Medication
timeFrame: 6 months
measure: Improvement of Range of Motion
timeFrame: 6 months
Other outcomes:
Locations:
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
Study officials:
affiliation: Vascular Institute of Virginia
name: Sandeep Bagla, MD
role: PRINCIPAL_INVESTIGATOR
References: