Neurostimulation Applied to Fibromyalgia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Pain intensity level
研究概览
简要总结
NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.
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
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
- •(2) been diagnosed for at least three months;
- •(3) be female;
- •(4) be in the age group between 25 and 60 years of age; and
- •(5) sign the consent form.
排除标准
- •(1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
- •(2) illiterate;
- •(3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
- •(4) history of convulsion;
- •(5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
- •(6) be pregnant.
研究组 & 干预措施
ano-M1-cat-SO5 tDCS
Participants will receive active transcranial direct current stimulation (tDCS) (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 5 consecutive days.
干预措施: Active tDCS (Device)
ano-M1-cat-SO10 tDCS
Participants will receive active transcranial direct current stimulation (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 10 consecutive days.
干预措施: Active tDCS (Device)
Sham tDCS
Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Pain intensity level
时间窗: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Changes in pain level, assessed by the Visual Analog Scale, ranges from 0 - 10, with 10 being the highest level of pain.
次要结局
- Quality of life level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Anxiety level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Depression level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Cognitive function(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Cortical electrical activity(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Health assessment level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Sleep quality(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
- Resilience(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
研究者
Géssika Araújo de Melo
Eliane Araújo de Oliveira
Federal University of Paraíba