Results from a United States Investigational Device Study of Adhesive Capsulitis Embolization in the Treatment of Shoulder Pain: The Adhesive Capsulitis Embolization Study

To evaluate the safety and efficacy of arterial embolization to relieve shoulder pain secondary to adhesive capsulitis (AC).In total, 20 patients (18 females, 2 males; mean age, 51 years) with AC resistant to >30 days of conservative treatment were enrolled in a multicenter prospective study. Adhesive capsulitis embolization was performed with 75-μm or 200-μm spherical particles. Subjects were assessed before and after the procedure with magnetic resonance imaging, visual analog scale (VAS; 0-100 mm) scores, Single Assessment Numeric Evaluation (SANE; 0-100) scores, and American Shoulder and Elbow Surgeons (ASES; 0-100) scores. Adverse events were recorded at all follow-up time points.Hypervascularity was identified and embolization was technically successful in all patients, with 83 arteries embolized in 20 patients. Baseline VAS, SANE, and ASES scores before the procedure were 89.2 mm, 27.2, and 30.9, respectively. The 1-month (n = 19), 3-month (n = 18), and 6-month (n = 12) follow-ups demonstrated significant improvements. At the 1-month follow-up, VAS score decreased by 31.8 (P = 1.2E-11), SANE score increased by 22.1 (P = 1.8E-8), and ASES score increased by 14.2 (P = 4.3E-5). At the 6-month follow-up, VAS score decreased by 62.1 (P = 7.0E-11), SANE score increased by 55.4 (P = 4.1E-10), and ASES score increased by 44.5 (P = 1.8E-6). Due to the coronavirus pandemic, the study ended early; 6 patients did not complete the 6-month follow-up. No major adverse events were noted.Interim findings suggest that arterial embolization is safe and effective for patients with AC refractory to conservative treatment.