Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Pain (VAS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Embolization
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.
干预措施: Embolization (Device)
Embolization
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.
干预措施: Physical Therapy (Other)
Physical Therapy
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.
干预措施: Physical Therapy (Other)
结局指标
主要结局
Visual Analog Scale Pain (VAS) Score
时间窗: 12 months
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.
次要结局
- Adverse Events(12 months)
- Shoulder Pain and Disability Index(12 months)
- MRI Tendinopathy scores(12 months)
- Patient-Reported Outcomes Measurement Information System Upper Extremity(12 months)
研究者
Yan Epelboym, M.D.,M.P.H.
Interventional Radiologist
Brigham and Women's Hospital