Actively Recruiting
Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff
Led by Brigham and Women's Hospital · Updated on 2026-02-06
41
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, transgender female, transgender male, non-binary
- Moderate to severe shoulder pain (Visual Analog Scale score greater than 40)
- Shoulder pain not improved after at least 6 months of physician-directed conservative therapy including at least 6 weeks of physical therapy
- Willing and able to provide informed consent and tolerate angiography and physical therapy
You will not qualify if you...
- History of peripheral arterial disease or symptoms like claudication or diminished limb pulses
- Known allergy to iodinated contrast agents, gadolinium contrast, poppy seeds, or Lipiodol
- Acute kidney injury or renal dysfunction (creatinine >1.6 dl/mg or eGFR <60 within 30 days)
- Uncorrectable blood clotting disorders (platelet count <50,000 or INR >1.8 within 30 days)
- Active infection in the upper extremity
- Pregnant or intending to become pregnant during the study
- Prior shoulder replacement surgery
- Prior rotator cuff repair surgery
- History of complete full-thickness rotator cuff tear
- Presence of non-MRI compatible implanted devices such as pacemakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for shoulder MRI and assessment
Duration - Up to 1 day for embolization procedure followed by 3 months of structured physical therapy
Participants in the embolization group undergo angiography to identify hyperemic shoulder arteries followed by embolization of abnormal vessels using Lipiodol, then start physical therapy.
1 angiography and embolization visit plus 4 physical therapy sessions over 12 weeks
Duration - 3 months
Participants in the physical therapy group undergo 3 months of structured eccentric strength training physical therapy.
4 physical therapy sessions at week 0, week 4, week 8, and week 12
Duration - Up to 12 months
Participants are monitored for outcomes and adverse events for up to 12 months after treatment.
Visits for outcome assessments as scheduled during follow-up period
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
Y
Yan Epelboym, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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