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Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment
Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Summary
Evaluation of the efficacy and safety of transcatheter arterial embolization using 'Nexsphere-F' for pain relief in patients with adhesive capsulitis of the shoulder joint that does not respond to conservative treatment. This study aims to investigate the efficacy and safety of transcatheter arterial embolization using embolic agents in patients with adhesive capsulitis of the shoulder joint. This is a single-center, prospective, open-label, randomized clinical trial.
Official title: A Single-center, Prospective, Open Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Arterial Embolization Using 'Nexsphere-F' in Patients With Adhesive Capsulitis of the Shoulder Joint Refractory to Conservative Treatment.
Key Details
Gender
All
Age Range
19 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-09-18
Completion Date
2027-08-31
Last Updated
2026-01-13
Healthy Volunteers
No
Interventions
Transcatheter Arterial Micro- Embolization (TAME)
A one-time transcatheter arterial micro-embolization (TAME) procedure will be performed via radial artery access. After angiographic identification of abnormal neovascularity or hypervascular lesions associated with shoulder pain, target vessels will be superselected with a microcatheter and embolized using Nexsphere-F (gelatin-based bioresorbable embolic particles) until angiographic stasis or marked reduction of abnormal hyperemia is achieved, according to operator judgement.
Usual care (conservative management)
Usual conservative management for shoulder pain provided as part of standard clinical care. Conservative treatments (e.g., physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection) may be provided based on clinical judgement and patient preference and are not mandated or standardized by the study protocol.
Locations (1)
Chung-Ang Univerisity Hospital
Seoul, South Korea