NCT02546362已完成不适用
A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint
研究概览
简要总结
The objective of this pilot open trial was to assess the efficacy and safety of external trigeminal nerve stimulation (e-TNS) with the Cefaly® device in fibromyalgia.
详细描述
The main objective of this clinical pilot trial was to evaluate the use of external trigeminal nerve stimulation (e-TNS) with the Cefaly® neurostimulator device as a new therapeutic treatment for fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from18 to 65 years (on the day of signing the informed consent form).
- •Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010).
- •Having a minimum pain score of at least 4 on the 0-10 Fibromyalgia Impact Questionnaire-revised (FIQR) pain scale at screening and baseline.
排除标准
- •Women: Pregnant, lactating or <6 months post partum.
- •Episodic or Chronic Migraine according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine 1, having two or more attacks per month.
- •Change in any medication acting on the central nervous system (CNS) within 28 days before start of the study or during the study.
- •Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score >
- •Botox injection within 4 months before baseline or during the study.
- •Psychiatric disorders that could interfere with study participation: bipolar disorder, psychotic disorders and dementia.
- •Suicidal behavior and/or ideation i.e. having a Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 4 during the preceding 2 years.
- •Patients currently taking any opioid medication.
- •Patients currently taking medically prescribed marijuana.
- •Current or history during the preceding year of alcohol or substance abuse including marijuana.
- •Widespread rheumatic diseases (other than fibromyalgia), evidence of inflammatory rheumatic disease.
- •Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments.
- •Implanted active metal or electrical devices in the head.
- •Cardiac pacemaker or implanted or wearable defibrillator.
- •Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program).
研究组 & 干预措施
Cefaly active device
Experimental
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
干预措施: Cefaly (Device)
结局指标
主要结局
Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint
时间窗: between baseline and 12-week timepoint
Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain).
Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint
时间窗: between baseline and 12-week timepoint
Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.
次要结局
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint(between baseline and 12-week timepoint)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint(between baseline and 12-week timepoint)
- Patient Global Impression of Change (PGIC) at 4-week Timepoint(at 4-week timepoint)
- Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Patient Global Impression of Change (PGIC) at 12-week Timepoint(at 12-week timepoint)
- Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint(between baseline and 12-week timepoint)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint(between baseline and 12-week timepoint)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint(between baseline and 4-week timepoint)
- Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint(between baseline and 12-week timepoint)
研究者
研究点 (2)
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