Actively Recruiting
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Led by Brigham and Women's Hospital · Updated on 2026-02-06
41
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (VAS > 40)
- Pain refractory to at least 6 months of physician-directed conservative therapy including a minimum of 6 weeks of physical therapy
- Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy
You will not qualify if you...
- History of peripheral arterial disease or symptoms limiting angiography
- Known anaphylaxis to iodinated contrast or gadolinium-based contrast
- Acute kidney injury
- Allergy to poppy seeds or lipiodol
- Renal dysfunction (serum creatinine >1.6 dl/mg or eGFR <60 within 30 days)
- Uncorrectable coagulopathy (platelet count <50,000 or INR >1.8 within 30 days)
- Active systemic or local upper extremity infection
- Pregnant or intending to become pregnant during the study
- Prior shoulder replacement surgery
- Prior rotator cuff repair surgery
- Previous complete full-thickness rotator cuff tear
- Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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