Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- change in pain
研究概览
简要总结
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.
- Trial with medical device
详细描述
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy (medical device). The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain (questionnaire), size of the calcinosis (ultrasound and CT), new ulcers and intake of painkillers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18
- •Calcinosis cutis due to connective tissue disease
- •information about ESWT given
- •Patient understands the study and signs the informed consent
排除标准
- •No ESWT done
- •cuagulopathy
- •pregnancy
- •pace maker
- •severe disease in the opinion of the investigator
- •cardiac risk with NYHA III-IV
- •Ehlers-Danlos-Syndrome
研究组 & 干预措施
shock wave therapy
intervention: shock wave therapy with Modulith SLK (Storz)
干预措施: shock wave therapy with Modulith SLK (Storz) (Device)
结局指标
主要结局
change in pain
时间窗: after 6 weeks
次要结局
未报告次要终点