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.
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
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
Parallel
Embolization
DeviceSuperselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.
Physical Therapy
Other interventionSubjects 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.
Visual Analog Scale Pain (VAS) Score
The difference in shoulder visual analog pain scale scores between TAE +PT and PT groups obtained 12 months following intervention vs. pre-intervention. The visual analog scale is ratio scale from 0 to 100 which measures pain symptoms. On this scale higher numbers indicated more severe pain symptoms.
Adverse Events
Compare the safety of TAE + PT relative to PT by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention
Patient-Reported Outcomes Measurement Information System Upper Extremity
Estimate the effect of TAE + PT vs PT on the change in Patient-Reported Outcomes Measurement Information System Upper Extremity scores at 1, 3, 6 and 12-months. A higher score indicates a better outcome. The scores can range from 15 to 61and are scored on what is called a T-score, a metric which reflects one standard deviation for each 10 points.
Shoulder Pain and Disability Index
estimate the effect of TAE + PT vs PT on the change in Shoulder Pain and Disability Index scores at 1, 3, 6 and 12-months. The scale is a ratio scale of 0 to 130 with higher scores indicating greater degree of pain and disability.
MRI Tendinopathy scores
Estimate the effect of TAE + PT vs PT on the change in MRI Tendinopathy scores at baseline and 12-months. The scale is ordinal and ranges from 0 to 3 with higher scores indicating a greater degree of tendinopathy.
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