Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient Pain
研究概览
简要总结
This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely.
详细描述
Purpose: The primary aims of this study are to determine if arterial embolization of the shoulder will reduce the severity of pain as well improve Range of Motion (ROM) caused by adhesive capsulitis and if it can be performed safely. The secondary aim is to determine if AES can result in the decreased necessity for ongoing conservative therapies, such as medication therapy and joint injections.
Participants: Twenty patients with adhesive capsulitis, resulting in shoulder pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.
Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing AES to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for arterial embolization of the shoulder, and follow-up visits at 24 hours, 1, 3 & 6 months. An MRI will be performed at the 1-month visit to detect a change in capsular vascularity and to exclude complication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe shoulder pain (VAS greater than 40mm), and
- •diagnosis of adhesive capsulitis, and
- •age > 21, and
- •pain refractory to at least 30 days of conservative therapy (pain medications, physical therapy, etc.)
排除标准
- •current local infection, or
- •life expectancy less than 6 months, or
- •known advanced atherosclerosis, or
- •rheumatoid or infectious arthritis, or
- •prior shoulder replacement surgery, or
- •uncorrectable coagulopathy as defined by INR > 2.5 or platelets < 30,000, or
- •iodine allergy resulting in anaphylaxis, or
- •renal dysfunction as defined by GRF of < 45, or
- •contraindication for magnetic resonance imaging, or
- •known complete full thickness tear of rotator cuff, or
- •currently pregnant
研究组 & 干预措施
Arterial Embolization of the Shoulder (AES)
Patients in this study will receive the arterial embolization of the shoulder (AES) procedure. The primary aims will be to determine if arterial embolization of the shoulder (AES) will reduce pain and improve range of motion (ROM) caused by adhesive capsulitis.
干预措施: Arterial Embolization of the Shoulder (Device)
结局指标
主要结局
Patient Pain
时间窗: 6 months
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the AES procedure). The investigators will use this to measure if the patient's pain level decreases.
Patient Function
时间窗: 6 months
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding range of motion, stiffness, and pain and how it affects the ability to function.
次要结局
- Reduction in Medication(6 months)
- Improvement of Range of Motion(6 months)
研究者
Sandeep Bagla
Principal Investigator, Sandeep Bagla, MD
Vascular Institute of Virginia