Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Pain Intensity Using Numeric Rating Scale
研究概览
简要总结
The purpose of this study is to determine the effects of mild cranial electrical stimulation on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status in persons with fibromyalgia.
详细描述
Central pain networks in the brain are dysregulated in persons with fibromyalgia (FM). Thus, the investigators propose that cranial electrical stimulation (CES) that works on the brain may ameliorate symptoms of FM by interacting with the central pain networks. The specific aims of this randomized, controlled, three-group pilot study design are to: (1) determine differences in pain over time between the active CES, sham device, and usual care (UC) groups; (2) explore differences in brain activity in pain processing regions (i.e., cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the active CES, sham device, and UC groups in a subset of 12 participants (6 in each device group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances, depression, perceived stress) and functional status, and blood pressure over time between the active CES, sham device, and UC groups; and (4) determine the amount of influence that selected psychological factors (negative affect, catastrophizing, and other personality characteristics) have on group differences in pain, other symptoms, functional status, and brain activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •meet the diagnostic criteria for FM established by the American College of Rheumatology
- •have initial pain level equal to or greater than 3 on a NRS 0-10
- •have stable medication use related to FM for at least 4 weeks
- •be able to read, write, and understand the English language
- •Exclusion Criteria (all participants):
- •pregnant or breastfeeding
- •epilepsy or history of seizures
- •presence of pacemakers and/or other implanted devices
- •Exclusion Criteria (subset of 12 participants who wil have fMRIs):
- •conditions that would not permit an fMRI (e.g., certain types of metal or metallic objects in body, diaphragm or intrauterine device, dermal patches, ear or eye implants, implanted electrical stimulators, artificial heart valve, implanted catheter or tube, tattoos, claustrophobia; or weight more than 275 lbs)
排除标准
- 未提供
研究组 & 干预措施
Usual care alone
No intervention; participants will receive usual medical care
CES device
Participants will use the device for 60 minutes each day for 8 weeks.
干预措施: CES device (Device)
Sham device
Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.
干预措施: sham device (Device)
结局指标
主要结局
Pain Intensity Using Numeric Rating Scale
时间窗: week 8
A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity
次要结局
- Functional Status Using the Fibromyalgia Index Questionnaire(Week 8)
- Depression Using the CES-D(Week 8)
- Perceived Stress Using Numeric Rating Scale(Week 8)
- Fatigue Using Lee's Fatigue Scale(Week 8)
- General Sleep Disturbance Scale(Week 8)
研究者
Ann G Taylor
Professor of Nursing
University of Virginia