Clinical Research Directory
Browse clinical research sites, groups, and studies.
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Sponsor: Brigham and Women's Hospital
Summary
This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.
Official title: Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff
Key Details
Gender
All
Age Range
21 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2025-01-16
Completion Date
2028-04-21
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Embolization
Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.
Physical Therapy
Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States