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
- 1
- 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.
研究组 & 干预措施
Ultrasound guided Needle Fragmentation
Ultrasound guided Needle Fragmentation (Intervention):
Using 15-20 to and fro gentle movements of the needle tip, the calcification will be fragmented, with the needle tip within the pseudocapsule. The needle tip will be retracted into the subacromial bursa and 3 ml of 0.5% sensorcaine and 1 ml of steroid ( Depomedrol- 40mg/ml) will be injected into the bursa. The needle will then be removed.
干预措施: Ultrasound guided Needle Fragmentation (Other)
US guided needle fragmentation & Lavage
Using local anesthetic and strict aseptic precautions, the tip of the 18-20 gauge needle will be advanced into the sub acromial bursa under ultrasound guidance and 2ml. of local anesthetic ( 1% xylocaine) will be injected into the bursa. The needle tip will be advanced into the supraspinatus tendon and ½ ml or less of 0.5% Sensorcaine will be injected into the pseudo capsule around the calcification. Using 15-20 to and fro gentle movements of the needle tip, the calcification will be fragmented, with the needle tip within the pseudo capsule. During this procedure, or after the fragmentation, using a syringe of saline or local anesthetic( 1% xylocaine) and with pumping action of the syringe the calcification with be sucked into the syringe.
干预措施: US guided needle fragmentation & Lavage (Other)
Ultrasound guided subacromial injection
Using local anesthetic and strict aseptic precautions, the tip of the 22 gauge needle will be advanced into the sub acromial bursa under ultrasound guidance and 4 ml. of local anesthetic ( 0.5% xylocaine) and 1 ml of steroid( Depomedrol 40 mg/ml) will be injected into the bursa. The needle will then be removed. Post procedure US images in the short and long axis planes will be obtained and documented. The patient's post procedure pain on a scale of 10 and their range of shoulder movement (abduction) will be assessed and documented.
干预措施: Ultrasound guided subacromial injection (Other)
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
- Complications and co existing conditions not detected prior to the procedure(Post ultrasound guided procedure through completion of study, up to one year)
- Costs and health resource utilization as measured by administrative and billing data related to treatment(Up to 8-12 months post surgery)
- 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