Cellulite and Extracorporeal Shock Wave - a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Nuernberger Score based on photo of cellulite
研究概览
简要总结
Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength programme is superior to the gluteal muscle strength programme alone in cellulite.
Study design: Randomized-controlled trial
Analysis: Intention-to-treat
Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow
Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal and thigh regions plus a specific gluteal strength exercise training
Follow-up: 12 weeks
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ages 18-65yrs Cellulite 1°-4° Informed consent
排除标准
- •Pregnancy Open wounds Females >18yrs or >65yrs
研究组 & 干预措施
Shockwave plus strength training
6 sessions of extracorporeal shock wave plus daily gluteal strength exercises
干预措施: Extracorporeal shockwave therapy (Device)
Sham extracorporeal shock wave plus gluteal strength exercise
SHAM extracorporeal shock wave plus gluteal strength exercise
干预措施: Sham extracorporeal shock wave plus gluteal strength exercise (Device)
结局指标
主要结局
Nuernberger Score based on photo of cellulite
时间窗: 12 weeks
次要结局
- Capillary blood flow(12 weeks)
- Circumference of thigh in cm(12 weeks)
- Tissue oxygen saturation(12 weeks)
- Postcapillary venous filling pressure(12 weeks)
研究者
Karsten Knobloch
Prof. Dr. Karsten Knobloch, FACS
Hannover Medical School