Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
研究概览
简要总结
The purpose of this study is to assess the effects on pain of transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients.
详细描述
Fibromyalgia 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.
Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.
In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.
The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients 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, Investigator, 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.
- •Normal pain intensity of 4 or more points on a visual analog 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.
- •Severe depression (Beck Depression Index II of 29 or more).
- •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 referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
时间窗: Baseline; immediately after intervention; 1-month 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. After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark).
Change in pain intensity from baseline to post-treatment
时间窗: Baseline; immediately after intervention; 1-month 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
次要结局
- Fibromyalgia Impact Quality-of-Life(Baseline; immediately after intervention; 1-month after intervention)
- Anxiety(Baseline; immediately after intervention; 1-month after intervention)
- Pain catastrophizing(Baseline; immediately after intervention; 1-month after intervention)
- Depression(Baseline; immediately after intervention; 1-month after intervention)