Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

NCT ID: NCT03676829

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2019-12-31

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.

Conditions

Frozen Shoulder; Adhesive Capsulitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arterial Embolization of the Shoulder (AES)

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.

Group Type: EXPERIMENTAL

Arterial Embolization of the Shoulder

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Vascular Institute of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Sandeep Bagla

Principal Investigator, Sandeep Bagla, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandeep Bagla, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Institute of Virginia

Locations

Vascular Institute of Virginia

Woodbridge, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie Orlando, CCRC

Role: CONTACT

jorlando@teamviv.com

703-763-5224

Molly Godin, RN

Role: CONTACT

mgodin@teamviv.com

703-763-5224

Facility Contacts

Julie Orlando, CCRC

Role: primary

jorlando@teamviv.com

703-763-5224

Molly Godin, RN

Role: backup

mgodin@teamviv.com

703-763-5224

Other Identifiers

20181853

Identifier Type: OTHER

Identifier Source: secondary_id

G180115

Identifier Type: -

Identifier Source: org_study_id