The Effect of Doppler Ultrasound on Calcified Tendinitis: a Double Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Need for a Second Ultrasound-Guided Injection
研究概览
简要总结
Calcific tendinitis of the shoulder, is a self-limiting disease characterized by the deposition of calcium phosphate crystals in the rotator cuff tendons. Patients will develop complications such as decreased range of motion of the shoulder joint, and thus reducing their quality of life. The most common site of occurrence is 1.5-2 cm away from the supraspinatus tendon insertion site on the greater tuberosity. The primary treatment for calcific tendinitis is conservative, such as non-steroidal anti-inflammatory analgesics for pain relieving, extracorporeal shock wave therapy, subacromial steroid injections, ultrasound-guided barbotage technique for aspirating and washing out calcific deposits. Ultrasound is being used in calcified tendinitis for evaluating its size, location, quality, and also using the color Doppler ultrasonography to evaluate its reactive inflammatory changes. However, the use of color Doppler ultrasonography in diagnosing and treating a shoulder pain with calcification is not being concluded yet. Therefore, the aim of this study is to evaluate the efficacy of color Doppler ultrasonography in calcified tendinitis.
详细描述
Purpose: To evaluate the efficacy of color Doppler ultrasonography in calcified tendinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic shoulder pain for more than 1 month
- •shoulder X-ray showed calcified deposit
排除标准
- •patient with needle phobia
- •patient with known allergy to medication like Triamcinolone and Lidocaine
研究组 & 干预措施
With Doppler ultrasound
The physician will use Doppler function detection to check if calcifications are under active inflammation before ultrasound-guided injection.
干预措施: ultrasound Doppler function detection (Diagnostic Test)
Without Doppler ultrasound
The physician will only open the Doppler image in the non-calcified area for patient blinding before the ultrasound-guided injection.
干预措施: ultrasound Doppler function detection (Diagnostic Test)
结局指标
主要结局
Need for a Second Ultrasound-Guided Injection
时间窗: between three days to one week after the initial ultrasound-guided injection
Whether a second ultrasound-guided injection is needed within a short period after the initial ultrasound-guided treatment, meaning whether significant improvement can be rapidly achieved after the first ultrasound-guided injection (defined as a reduction in pain index ≥50%).
次要结局
- Size of Calcification(before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection)
- Pain Index (Visual Analogue Scale, VAS)(before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection)
- Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnaire(before treatment, between three days to one week after the initial ultrasound-guided injection, within the fourth week after the initial ultrasound-guided injection)