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

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.

Study Overview

• Status: Unknown
• Conditions: Adhesive Capsulitis; Frozen Shoulder
• Intervention / Treatment: Device: Arterial Embolization of the Shoulder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Julie Orlando, CCRC; Phone Number: 703-763-5224; Email: jorlando@teamviv.com
• Study Contact Backup: Name: Molly Godin, RN; Phone Number: 703-763-5224; Email: mgodin@teamviv.com

Study Locations

• United States
  • Virginia
    • Woodbridge, Virginia, United States, 22193
      • Recruiting
      • Vascular Institute of Virginia
      • Contact: Julie Orlando, CCRC; Phone Number: 703-763-5224; Email: jorlando@teamviv.com
      • Contact: Molly Godin, RN; Phone Number: 703-763-5224; Email: mgodin@teamviv.com
      • Principal Investigator: Sandeep Bagla, MD
      • Sub-Investigator: Rachel Piechowiak, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain	The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the AES procedure). The investigators will use this to measure if the patient's pain level decreases.	6 months
Patient Function	The American Shoulder and Elbow Surgeons Shoulder Score (ASES) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding range of motion, stiffness, and pain and how it affects the ability to function.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Medication	Reduction in the number or strength of previously initiated medical therapy (e.g. NSAIDs).	6 months
Improvement of Range of Motion	Patients' range of motion will be assessed prior to undergoing embolization and at 1,3, and 6 month follow ups.	6 months

Collaborators and Investigators

• Sponsor: Vascular Institute of Virginia
• Collaborators: Terumo Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: G180115; 20181853 (Other Identifier: WIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes