Evaluating Transcatheter Arterial Embolization Using Nexsphere-F for Treating Pain in Adhesive Capsulitis of the Shoulder When Conservative Treatments Fail

What this Trial Is About

Researchers are evaluating the effectiveness and safety of transcatheter arterial embolization using a material called Nexsphere-F for relieving pain in patients with adhesive capsulitis of the shoulder joint, commonly known as frozen shoulder, who have not improved with standard treatments. This single-center, prospective, open-label, randomized clinical trial aims to better understand this procedures impact on shoulder pain and function. Participants in this trial are randomly assigned to one of two groups. The experimental group will receive a one-time transcatheter arterial micro-embolization TAME procedure using Nexsphere-F, which involves blocking certain blood vessels in the shoulder to reduce pain. The control group will continue with usual conservative care, such as physical therapy, pain medications, or local injections, based on clinical judgment and patient preference. Both groups will be monitored and evaluated over time. Throughout the study, participants will have their pain measured using the Visual Analog Scale VAS at several points before the procedure and at 1 week, 1 month, 3 months, and 6 months afterward. Additional assessments include shoulder range of motion ROM, American Shoulder and Elbow Surgeons ASES scores, Single Assessment Numeric Evaluation SANE scores, and patient satisfaction surveys. Magnetic resonance imaging MRI scans of the shoulder will be taken before the procedure and at 6 months to observe structural changes. Follow-up evaluations will be conducted through hospital visits or telephone interviews over a 6-month period.

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