NCT00506038终止2 期
Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
研究概览
简要总结
Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life.
One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance.
This treatment includes identification the tendonitis with US or screening , local anesthesia and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10 minutes, relatively cheap ,safe and usually with good outcomes. However in the literature there is a lack of controlled prospective trials.
Our goal is to set a study that will evaluate this treatment between two groups:
- Puncturing the calcium in the rotator cuff 15 times (the experiment group)
- Puncturing the calcium in the rotator cuff twice (the controlled group)
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
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above.
- •6 months of pain in the shoulder.
- •Positive IMPING and sensitivity on SST.
- •Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
- •Completed conservative treatment: physiotherapy or analgesics.
排除标准
- •Diabetes, Nephrological diseases
- •RC tear according to US.
- •Prior operation in this shoulder
- •Steroids injection in the last three months.
- •A patient that is in the absorption phase of the tendinitis
- •Coagulation System impairments
研究者
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