Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

NCT03676829 | Unknown Phase 1 FDA Device

• 2 other identifiers: G18011520181853
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Reduction in Medication

  6 months

• Improvement of Range of Motion

  6 months

Study Arms (1)

Arterial Embolization of the Shoulder (AES)

EXPERIMENTAL

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

Interventions

Arterial Embolization of the Shoulder 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.

Arterial Embolization of the Shoulder (AES)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Institute of Virginia: lead
• Terumo Medical Corporation: collaborator

Study Sites (1)

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Sandeep Bagla, MD

  Vascular Institute of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Orlando, CCRC

CONTACT

703-763-5224; jorlando@teamviv.com

Molly Godin, RN

CONTACT

703-763-5224; mgodin@teamviv.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Sandeep Bagla, MD

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: September 13, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)