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RECRUITING
NCT06095050
NA

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

Embolization

Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.

OTHER

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