A User Study of SYNUS Pain Relief Made by Tivic Health Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.
详细描述
A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age and older
- •Present with symptoms of sinus pain and pressure
- •Have an initial sinus pain score of 4 or more on the visual analogue scale
- •Be able to read and understand English
- •Agree to participate in the study
- •Be able and willing to provide Informed Consent
排除标准
- •Do not meet Inclusion Criteria
- •Have currently a dental infection
- •Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention
- •Be currently pregnant
- •Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant
结局指标
主要结局
Pain reduction
时间窗: 10 minutes
Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device.
次要结局
未报告次要终点