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

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ClinicalTrials.gov Identifier: NCT03676829
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
Terumo Medical Corporation
Information provided by (Responsible Party):
Sandeep Bagla, Vascular Institute of Virginia

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.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Adhesive Capsulitis Device: Arterial Embolization of the Shoulder Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

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.




Primary Outcome Measures :
  1. Patient Pain [ Time Frame: 6 months ]
    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.

  2. Patient Function [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Reduction in Medication [ Time Frame: 6 months ]
    Reduction in the number or strength of previously initiated medical therapy (e.g. NSAIDs).

  2. Improvement of Range of Motion [ Time Frame: 6 months ]
    Patients' range of motion will be assessed prior to undergoing embolization and at 1,3, and 6 month follow ups.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676829


Contacts
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Contact: Julie Orlando, CCRC 703-763-5224 jorlando@teamviv.com
Contact: Molly Godin, RN 703-763-5224 mgodin@teamviv.com

Locations
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United States, Virginia
Vascular Institute of Virginia Recruiting
Woodbridge, Virginia, United States, 22193
Contact: Julie Orlando, CCRC    703-763-5224    jorlando@teamviv.com   
Contact: Molly Godin, RN    703-763-5224    mgodin@teamviv.com   
Principal Investigator: Sandeep Bagla, MD         
Sub-Investigator: Rachel Piechowiak, DO         
Sponsors and Collaborators
Vascular Institute of Virginia
Terumo Medical Corporation
Investigators
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Principal Investigator: Sandeep Bagla, MD Vascular Institute of Virginia

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Responsible Party: Sandeep Bagla, Principal Investigator, Sandeep Bagla, MD, Vascular Institute of Virginia
ClinicalTrials.gov Identifier: NCT03676829     History of Changes
Other Study ID Numbers: G180115
20181853 ( Other Identifier: WIRB )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases