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
|Condition or disease||Intervention/treatment||Phase|
|Frozen Shoulder Adhesive Capsulitis||Device: Arterial Embolization of the Shoulder||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Reduction in Medication [ Time Frame: 6 months ]Reduction in the number or strength of previously initiated medical therapy (e.g. NSAIDs).
- 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.
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
|Contact: Julie Orlando, CCRCfirstname.lastname@example.org|
|Contact: Molly Godin, RNemail@example.com|
|United States, Virginia|
|Vascular Institute of Virginia||Recruiting|
|Woodbridge, Virginia, United States, 22193|
|Contact: Julie Orlando, CCRC 703-763-5224 firstname.lastname@example.org|
|Contact: Molly Godin, RN 703-763-5224 email@example.com|
|Principal Investigator: Sandeep Bagla, MD|
|Sub-Investigator: Rachel Piechowiak, DO|
|Principal Investigator:||Sandeep Bagla, MD||Vascular Institute of Virginia|