Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

This is a single center prospective randomized controlled study at Brigham & Women's Hospital (BWH), a teaching hospital of Harvard Medical School. Patients with clinical and MRI findings of shoulder tendinopathy, moderate to severe shoulder pain (VAS > 40), and pain refractory to at least 6 months of physician directed conservative therapy will be eligible for enrollment.At screening patient will undergo a shoulder MRI to evaluate for tendinopathy, and patients with complete full thickness tendon tears will be excluded.

Patients will be randomized to either the TAE +PT or PT group. Patients in the TAE + PT group will undergo angiography to evaluate branch shoulder arteries for hyperemia. If hyperemia is present, then embolization will be performed. This treatment will be followed by 3 months of structured PT. Patients in the PT group will undergo 3-months of structured physical therapy with isolated eccentric exercises.

Inclusion criteria

• 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

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.
• Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.8 within 30 days of procedure
• Active systemic or local upper extremity infection
• Patient pregnant, intending to become pregnant during the study.
• Prior shoulder replacement surgery
• Prior rotator cuff repair surgery
• Previous history of complete full-thickness tear of the rotator cuff
• Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).