A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Differences between treatment groups in pain free rates at 2 hours post treatment.
研究概览
简要总结
This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).
详细描述
This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser.
It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.
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
- Triple (Participant, Care Provider, Investigator)
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
- •male or female
- •aged 18 or older;
- •subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
- •1-20 headache days per month;
- •history of at least moderate pain if migraine left untreated.
排除标准
- •headache on greater than 25 days/month on average for preceding 3 months;
- •headache on greater than 25 days in present month;
- •headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;
- •women of child bearing age not using acceptable method of contraception;
- •pregnant or nursing women;
- •history of malignancy of any organ
- •uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
- •light sensitivity;
- •retinal disease;
- •intranasal pathology.
研究组 & 干预措施
Sham
Sham low energy laser using approximately 1/1000 th energy of treatment laser.
干预措施: Argus Migraine Treatment device (Device)
Treatment
Treatment laser.
干预措施: Argus Migraine Treatment device (Device)
结局指标
主要结局
Differences between treatment groups in pain free rates at 2 hours post treatment.
时间窗: 2 hours post treatment
次要结局
未报告次要终点