NCT07336849

Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Pain levels will be assessed via outpatient visits or telephone interviews at baseline (pre-procedure), and at 1 week, 1 month, 3 months, and 6 months post-procedure. During outpatient visits, the Visual Analog Scale (VAS), American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, shoulder range of motion (ROM), and the patient's subjective satisfaction (satisfied or not) will be recorded. Magnetic resonance imaging (MRI) of the shoulder joint will be performed both before the procedure and at 6 months post-procedure in both the control and intervention groups for comparative evaluation.

Conditions

• Adhesive Capsulitis of the Shoulder
• Frozen Shoulder
• Shoulder Adhesive Capsulitis

Interventions

Type	Name	Description
PROCEDURE	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.
OTHER	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.

Timeline

• Start date: 2025-09-18
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: South Korea