Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

Phase 1

• Conditions: Adhesive Capsulitis; Frozen Shoulder
• Interventions: Device: Arterial Embolization of the Shoulder

• Registration Number: NCT03676829
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-13
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-21
• Primary Completion: 2019-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arterial Embolization of the Shoulder (AES)	Arterial Embolization of the Shoulder	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.

Primary Outcome Measures

Name	Time	Method
Patient Pain	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	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

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

Trial Locations

Locations (1)

Vascular Institute of Virginia; 🇺🇸 Woodbridge, Virginia, United States