Efficacy of Unihemispheric Concurrent Dual-Site Anodal Transcranial Direct Current Stimulation Combined With Therapeutic Exercise on Fatigue and Sleep in Fibromyalgia. Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in fatigue from baseline to post-treatment as assessed by MFI.
研究概览
简要总结
The purpose of this study is to assess the effects on fatigue and sleep of Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise in Fibromyalgia patients.
详细描述
Fibromyalgia (FM) is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated.
Perhaps this is why its therapeutic approach is refractory to current treatments.
Apart from the widespread chronic pain characteristic of this syndrome, fatigue is a very disabling symptom in this pathology. It is a complicated, multifactorial, disconcerting and very persistent symptom that is highly frequent in FM. A vast majority of the published studies have focused the symptoms studied in FM on pain, while fatigue and sleep disturbances, despite not being minor symptoms, have not received the same attention.
Neuromodulation treatments with transcranial direct current stimulation (tDCS) have been shown to induce significant analgesia in FM through modification of sensory processing of pain by thalamic inhibitory circuits and improvement of sleep architecture. On the other hand, therapeutic exercise (TE) programs based on aerobic work and global muscle strengthening have been shown to have a beneficial effect in reducing the pain and severity of FM.
None of the four studies conducted so far combining tDCS and TE in fibromyalgia have evaluated the effect on fatigue or sleep. Currently, various studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation (UHCDS a-tDCS) on the dorsolateral prefrontal cortex (DLPFC) and M1 produces a 50% greater modulation of corticospinal excitability. To date, no RCT has studied its effect in subjects with FM.
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, Outcomes Assessor)
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
- •Age between 18 and 65 years.
- •Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- •Able to participated in a therapeutic exercise program.
- •Understanding of spoken and written Spanish.
排除标准
- •Pregnancy or breastfeeding.
- •Metallic implants in the head.
- •Tumor, trauma or surgery in the brain.
- •Epilepsy or stroke.
- •History of substance abuse in the last 6 months.
- •Use of carbamazepine in the last 6 months.
- •Diagnosed psychiatric pathology.
- •Rheumatic pathology not medically controlled.
- •Coexisting autoimmune pathology.
- •Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
结局指标
主要结局
Change in fatigue from baseline to post-treatment as assessed by MFI.
时间窗: Baseline; immediately after intervention; 1-month after intervention
The version adapted to Spanish from the Multidimensional Fatigue Inventory (MFI) will be used. The scale ranges from 0 to 100. Higher values represent a worse result.
Change in sleep quality from baseline to post-treatment as assessed by MOS-SS.
时间窗: Baseline; immediately after intervention; 1-month after intervention
The version adapted to Spanish from the Medical Outcomes Study Sleep Scale (MOS-SS) will be used. The scale ranges from 0 to 100. Higher values represent a worse result.
次要结局
- Blinding(Immediately after intervention.)
- Fibromyalgia Impact Quality-of-Life(Baseline; immediately after intervention; 1-month after intervention)