Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• Male, female, transgender female, transgender male, non-binary

• Moderate to severe shoulder pain (VAS \> 40)

• Pain refractory to at least 6 months of physician-directed conservative therapy (analgesics or injections or PT), including a minimum of 6 weeks of PT

• Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Yan Epelboym, MD, MPH
yepelboym@bwh.harvard.edu
6177327257
Time Frame
Start Date: 2025-01-16
Estimated Completion Date: 2027-04-21
Participants
Target number of participants: 41
Treatments
Experimental: Embolization
Angiography will be performed to identify hyperemic neovasculature arising from one or more of branch shoulder arteries. After localizing the abnormal neovessels a microcatheter will be inserted coaxially and selectively placed in the targeted artery(ies). The abnormal vessels will be embolized with Lipiodol emulsion (Guerbet, Villepinte, France) The embolic agent will be used under an investigational device exemption from the FDA. The embolic will be injected in small volume increments until blood flow stagnates in the target artery(ies).~Angiography and embolization will be repeated until the hyperemia is markedly reduced as demonstrated on digital subtraction angiography.~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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov