Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff

Conditions
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Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Embolization, Arterial Occlusion

Intervention / Treatment
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* Device: Embolization
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center prospective randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization<br>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. | Device: Embolization<br>* Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.<br>Other: Physical Therapy<br>* 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.<br>|
| Active Comparator: Physical Therapy<br>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. | Other: Physical Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, shoulder pain, tendinopathy