tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Toledo
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Talavera De La Reina、Toledo、西班牙、45600
- Hospital General Nuestra Señora del Prado
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：控制
没有治疗。
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实验性的：Real tDCS + exercise
Transcranial direct current stimulation combined with therapeutic exercise
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Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days.
The program will include exercises and will last 30-45 minutes.
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假比较器：Sham tDCS + exercise
Sham transcranial direct current stimulation combined with therapeutic exercise
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The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days.
The program will include exercises and will last 30-45 minutes.
Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.
Sham tDCS will be applied for the same time than real tDCS.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
大体时间：Baseline; immediately after intervention; 1-month after intervention
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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). |
Baseline; immediately after intervention; 1-month after intervention
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Change in pain intensity from baseline to post-treatment
大体时间：Baseline; immediately after intervention; 1-month after intervention
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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
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Baseline; immediately after intervention; 1-month after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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纤维肌痛影响生活质量
大体时间：基线；干预后立即；干预后1个月
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它将使用适用于西班牙语的纤维肌痛影响问卷 (FIQ) 的版本进行测量。
比例范围从 0 到 100。
较高的值表示较差的结果。
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基线；干预后立即；干预后1个月
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Anxiety
大体时间：Baseline; immediately after intervention; 1-month after intervention
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The version adapted to Spanish from the State Scale (STAI-ES) of the State-Trait Anxiety Inventory (STAI) will be used.
The scale ranges from 0 to 60. Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Pain catastrophizing
大体时间：Baseline; immediately after intervention; 1-month after intervention
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The Spanish version of the Pain Catastrophizing Scale (PCS) will be used.
The scale ranges from 0 to 52.
Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Depression
大体时间：Baseline; immediately after intervention; 1-month after intervention
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The adaptation to the Spanish of Beck Depression Inventory II will be used.
The scale ranges from 0 to 63.
Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Blinding
大体时间：Immediately after intervention
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Blinding of subjects and researchers will be assessed using the James Index.
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Immediately after intervention
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Real tDCS的临床试验
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University of California, San Francisco招聘中