Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Blood Flow (Perfusion Unit)
研究概览
简要总结
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
排除标准
- •Is pregnant/nursing
- •Has an active infection, open sores, or wounds in the treatment area
- •Has any preexisting extremity circulation condition
研究组 & 干预措施
SAM Ultrasound Device and Diclofenac Patch 1
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on right forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: Sustained Acoustic Medicine (Device)
SAM Ultrasound Device and Diclofenac Patch 1
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on right forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: 2.5% Diclofenac Patches (Drug)
SAM Ultrasound Device and Diclofenac Patch 2
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on left forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: Sustained Acoustic Medicine (Device)
SAM Ultrasound Device and Diclofenac Patch 2
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on left forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: 2.5% Diclofenac Patches (Drug)
SAM Ultrasound Device and SAM Patch 1
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with standard ultrasound gel patch on right forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: Sustained Acoustic Medicine (Device)
SAM Ultrasound Device and SAM Patch 2
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with standard ultrasound gel patch on left forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: Sustained Acoustic Medicine (Device)
结局指标
主要结局
Blood Flow (Perfusion Unit)
时间窗: 0 - 1 hour
Blood Flow Flux through Upper Extremity (Perfusion Unit)
Ultrasound Diathermy (Degrees Centigrade)
时间窗: 0 - 1 hour
Temperature Measurement on Body (Degrees Centrigrade)
次要结局
未报告次要终点