Study of Lipiodol Embolization and Physical Therapy for Treating Chronic Rotator Cuff Tendinopathy with Moderate to Severe Shoulder Pain

What this Trial Is About

Researchers are evaluating the effect of transcatheter arterial embolization TAE combined with physical therapy PT compared to PT alone in patients with moderate to severe shoulder pain due to rotator cuff tendinopathy that has not improved with conservative treatment. This study is a randomized controlled trial conducted at a single center, aiming to measure changes in shoulder pain over 12 months and assess safety and patient-reported outcomes such as PROMIS Upper Extremity scores, SPADI scores, and MRI Tendinopathy scores. Participants will be randomly assigned to receive either TAE plus structured physical therapy or physical therapy alone. Those in the TAE plus PT group will undergo angiography to identify hyperemic shoulder arteries, followed by embolization using Lipiodol emulsion under an investigational device exemption. Both groups will participate in a 12-week eccentric strength training physical therapy program with sessions at weeks 0, 4, 8, and 12. During the study, participants will have clinical evaluations including MRI scans at screening and outcome assessments at 12 months. Researchers will monitor shoulder pain levels using the Visual Analog Scale and track adverse events and changes in functional scores. The study involves a follow-up period of one year to assess pain and disability changes after treatment.

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy