Embolization Treatment of Chronic Refractory Shoulder Tendinopathy (ELECTRC)
Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring pain, shoulder pain, tendinopathy
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Embolization with Physical Therapy
Physical Therapy
Angiography will be performed to identify hyperemic neovasculature arising from one or more of branch shoulder arteries. After localizing the abnormal neovessels a microcatheter will be inserted coaxially and selectively placed in the targeted artery(ies). The abnormal vessels will be embolized with Lipiodol emulsion (Guerbet, Villepinte, France) The embolic agent will be used under an investigational device exemption from the FDA. The embolic will be injected in small volume increments until blood flow stagnates in the target artery(ies). Angiography and embolization will be repeated until the hyperemia is markedly reduced as demonstrated on digital subtraction angiography. Subjects 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.
Subjects 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.