Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
United States41 participantsStarted 2025-01-16
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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
Exclusion criteria
✕. History of peripheral arterial disease or peripheral artery disease symptoms including claudication, diminished or absent upper/lower extremity pulses, or known upper extremity arterial atherosclerosis or occlusion that would limit selective angiography
✕. Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
✕. Acute kidney injury
✕. Allergy to poppy seeds or lipiodol
✕. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.