Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Perceived pain
研究概览
简要总结
The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.
详细描述
Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:
- To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
- To investigate tDCS induced functional changes in the brain by using fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
- •Mean VAS > 4 daily 2 weeks prior to study).
排除标准
- •Severe mental disease
- •CNS disease
- •Mental retardation
- •Age < 18
结局指标
主要结局
Perceived pain
时间窗: Change in VAS from baseline up to 49 days.
Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\\sham tDCS on pain. 2 levels of group (active tDCS\\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome).
次要结局
- Cerebral pain processing(Change from baseline to post treatment. 7 days.)
- Rating scales (HADS, SCL90, SF36, FIQ)(Change from baseline to post treatment. 30 days post treatment. Up to 65 days.)
- Perceived pain, natural history(Baseline compared to post-treatment. Up to 65 days)
- Perceived stress and activation(Change in VAS from baseline to during treatment and after treatment. Up to 49 days.)
- Perceived stress and activation, natural history(Baseline compared to post-treatment. Up to 65 days)