Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- VAS for pain
研究概览
简要总结
To the investigators knowledge there are no studies of Trigeminal Nerve Stimulation (TNS) for fibromyalgia. TNS may modify overlapping mood and fibromyalgia pain regulation circuitry. The investigators hypothesized that patients with fibromyalgia might experience a clinically significant reduction in daily pain if investigators were to administer TNS in a manner similar to experimental antidepressant protocols.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will adopt the following inclusion criteria: (1) patients between 18 and 69 years; (2) patients with a diagnosis of fibromyalgia according to a trained phisycian; (3) score greater than or equal to 5 on the VAS for pain; (4) agreement to participate in the study as recommended in the IC.
排除标准
- •Exclusion criteria we cite: (1) patients with psychiatric hospitalization indicated; (2) patients with psychiatric comorbidity; (3) patients with a diagnosis of personality disorder; (4) presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic decompensated.
研究组 & 干预措施
Trigeminal nerve stimulation - active
10-day TNS interventional protocol over an 10-day follow-up
干预措施: Trigeminal nerve stimulation (Device)
Trigeminal nerve stimulation
10-day sham interventional protocol over an 10-day follow-up
干预措施: Trigeminal nerve stimulation (Device)
结局指标
主要结局
VAS for pain
时间窗: 10 day-follow up
Comparison between VAS for pain after intervention protocol and baseline score
次要结局
未报告次要终点
研究者
Pedro Shiozawa
Coordinator - Laboratory of Clinical Neuromodualtion
Santa Casa Medical School