Study to Evaluate Ultrasound Guided Interventions of Calcific Tendonitis of Rotator Cuff- International CollabratioN (SUCTION)
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Decrease in Pain as measured by the Visual analog scale from 1-10
研究概览
简要总结
The purpose of this study is to determine whether minimally invasive treatments like ultrasound guided needle fragmentation with and without lavage is associated with better clinical outcomes compared to the subacromial bursal corticosteroid injection treatment only.
详细描述
The objectives of this study are to compare the clinical outcomes of the three treatment arms: ultrasound guided needle fragmentation with lavage, ultrasound guided needle fragmentation without lavage, and subacromial bursal corticosteroid injection treatment. The study design is a randomized control trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men or women ages 18 to 60 years
- •Shoulder pain ( including impingement pain) and reduced range of shoulder movement for greater than 6 months with no relief from non-operative means (physiotherapy, nonsteroidal anti-inflammatory medication, rest).
- •Documentation of failed physiotherapy and conservative management.
- •Calcific tendonitis as diagnosed on ultrasound.
- •Informed consent from participant.
- •Ability to speak, understand and read in the language of the clinical site.
排除标准
- •Previous inclusion in a study involving calcific tendonitis of the rotator cuff
- •Evidence of a calcification in any of the rotator cuff tendons except the supraspinatus tendon.
- •Presence of a tear of the rotator cuff.
- •The supraspinatus tendon calcification is more than 1.5 cm is its largest dimension.
- •Concomitant clinical or MRI diagnosis of frozen shoulder.
- •Previous rotator cuff or shoulder surgery.
- •Those on blood thinners.
- •Those with allergies to medication used.
- •Those with a skin infection at the site of needle entry.
- •Immunosuppressive medication use.
- •Chronic pain syndromes.
- •Significant medical co-morbidities (requiring daily assistance).
- •Ongoing litigation or compensation claims secondary to shoulder problems.
- •Age below 18 years and above 60 years.
- •Any other reasons given to exclude the patient.
结局指标
主要结局
Decrease in Pain as measured by the Visual analog scale from 1-10
时间窗: 8 months
Pain in the original symptomatic area of the rotator cuff will be reassessed using the visual analog scale from 1-10 (1 being the lowest pain and 10 being the highest)
Decreased Range of Motion in the shoulder measured in degrees
时间窗: 8 months
Abduction, internal rotation, external rotation and circumduction of the shoulder
次要结局
- Costs and health resource utilization as measured by administrative and billing data related to treatment(Up to 8-12 months post surgery)
- Complications and co existing conditions not detected prior to the procedure(Post ultrasound guided procedure through completion of study, up to one year)
- Generic physical and mental health as measured by EuroQol(Up to 8-12 months post surgery)
- The ultrasound appearance of the targeted calcification(Up to 8-12 months post surgery)
研究者
Hema Choudur
Associate Professor, Department of Radiology
Hamilton Health Sciences Corporation