Recruiting
Phase 1
Phase 2

Embolization

Sponsor:

Vascular Institute of Virginia

Code:

NCT03676829

Conditions

Frozen Shoulder

Adhesive Capsulitis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Arterial Embolization of the Shoulder

Study Details

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.

Conditions

Frozen Shoulder

Adhesive Capsulitis

Study ID

NCT03676829

Start date

Sep 13, 2018

Status verified date

Sep, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Patient Pain [ Time Frame: 6 months ]
  • Patient Function [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Julie Orlando, CCRC

703-763-5224jorlando@teamviv.com

Molly Godin, RN

703-763-5224mgodin@teamviv.com

Locations

Vascular Institute of Virginia

Recruiting

Woodbridge, Virginia, United States, 22193

Contacts

Julie Orlando, CCRC

703-763-5224jorlando@teamviv.com

Molly Godin, RN

703-763-5224mgodin@teamviv.com

Principal Investigator:

Sandeep Bagla, MD

More Information

Sponsor

Vascular Institute of Virginia

Last update posted

Sep 21, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vascular Institute of Virginia on 2018-09-21.