Efficacy of Unihemispheric Concurrent Dual-Site Anodal Transcranial Direct Current Stimulation Combined With Therapeutic Exercise on Pain in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Pain intensity.
研究概览
简要总结
The present study aims to investigate the effect of a Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise on pain in subjects with FM.
详细描述
Fibromyalgia (FM) syndrome is characterized as a cardinal symptom of chronic pain. It is one of the rheumatic diseases with the greatest impact on quality of life.
Although the etiology and pathophysiology are not yet completely clear, FM is related to specific changes in brain activity, such as a decrease in blood flow in the thalamus, caudate nucleus and pons tegmentum. This could be related to the appearance of a disorder in pain regulation, characterized by an alteration of the sensory and pain process in the central nervous system, due to neuroplastic changes in the neural circuits related to pain. Imaging studies have shown that FM could be associated with functional changes in the brain, such as a reduction in connectivity in efferent pain inhibitory pathways and central sensitization in afferent pain pathways, resulting in an increase in pain perception.
The most common FM treatment guidelines recommend aerobic exercise as the only non-pharmacological therapy with level A recommendation in the treatment of FM. In the same way, it concludes that it is more than recommended to combine therapies assuming synergistic effects between them.
Neuromodulation treatments with transcranial direct current stimulation (tDCS) have been shown to induce significant analgesia in FM through the modification of sensory processing of pain by thalamic inhibitory circuits. To date, the few studies that have combined tDCS and therapeutic exercise in FM have applied tDCS to the primary motor cortex (M1) in isolation. Currently, several 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 in healthy subjects. To date, there is no study that has evaluated the effectiveness of this novel application of tDCS in subjects with FM on pain.
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.
- •Usual pain intensity of 4 or more points on a visual analogue scale.
- •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
Pain intensity.
时间窗: Baseline; inmediately after intervention; 3-months after intervention.
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable.
Referred pain area after suprathreshold pressure stimulation.
时间窗: Baseline; inmediately after intervention; 3-months after intervention.
A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds.
次要结局
- Anxiety.(Baseline; inmediately after intervention; 3-months after intervention.)
- Pain catastrophizing.(Baseline; inmediately after intervention; 3-months after intervention.)
- Depression.(Baseline; inmediately after intervention; 3-months after intervention.)