Phototherapy For Treatment Of Raynaud's Phenomenon
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Visual Analog Scale (VAS) of Numbness
研究概览
简要总结
To determine if blue light therapy can improve the symptoms of Raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.
详细描述
The purpose of this study is to test the efficacy of blue light phototherapy for the treatment of Raynaud's phenomenon (RP) in human participants. The specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that RP participants experience. This will be measured through the use of a visual analog scale (VAS) of both pain and numbness. This study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. Together, the visual analog scale (VAS) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced RP symptoms due to vasodilation of blood vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome
排除标准
- •Those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them.
- •Inability of the subject to place their hands into the PTD portal because of physical size or discomfort.
- •Inability of the subject to wear protective eyewear.
- •Anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures.
- •Females who are pregnant.
- •Adults unable to consent for any reason not explicitly stated herein.
结局指标
主要结局
Change in Visual Analog Scale (VAS) of Numbness
时间窗: 4 hours
Participants will be asked to rate their numbness upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.
Change in Visual Analog Scale (VAS) of Pain
时间窗: 4 hours
Participants will be asked to rate their pain upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.
次要结局
- Skin Temperature(4 hours)