Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol
Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol
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DOI：
10.1136/bmjopen-2019-032710
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发表时间：
2019-10-01
期刊：
影响因子：
2.9
通讯作者：
Fregni, Felipe
中科院分区：
文献类型：
--
作者：
Castelo-Branco, Luis;Kucukseymen, Elif Uygur;Fregni, Felipe
简介纤维肌痛（FM）是一种常见的使人衰弱的疾病，治疗选择有限。药物的疗效低，往往与不良反应有关。鉴于FM与有缺陷的内源性疼痛控制系统和中枢致敏，结合干预措施，如经颅直流电刺激（tDCS）和有氧运动（AE），以调节疼痛处理circuits可能会提高pain control.Methods和analysis一个前瞻性的，随机（1：1：1：1），安慰剂对照，双盲，析因临床试验将测试的假设，优化tDCS（16阳极tDCS会议结合AE）可以恢复的疼痛内源性控制系统。FM受试者（n=148）将接受条件运动期，并随机分配至四组之一：（1）活动性tDCS和AE，（2）假tDCS和AE，（3）活动性tDCS和非有氧运动（nAE）或（4）假tDCS和nAE。将使用条件性疼痛调节（CPM）和时间性缓慢疼痛总和（TSPS）-主要结局评估疼痛抑制活性。次要结局将包括以下评估：经颅磁刺激和脑电图作为疼痛抑制控制和丘脑皮质回路的皮质标记物;疼痛、FM、生活质量、睡眠和抑郁的次要临床结局。最后，将检验本研究中两个主要机制目标（CPM和TSPS）与次要临床结局变化之间的关系。主要疗效终点CPM和TSPS从基线到刺激第4周的变化将用混合线性模型进行测试，并对重要的人口统计学变量进行调整。伦理和传播本研究遵守赫尔辛基宣言，并由Partners Healthcare的机构审查委员会（IRB）批准，方案编号为2017 P002524。将获得受试者的知情同意书。研究结果将在会议和同行评议的期刊出版物中报告。
Introduction Fibromyalgia (FM) is a common debilitating condition with limited therapeutic options. Medications have low efficacy and are often associated with adverse effects. Given that FM is associated with a defective endogenous pain control system and central sensitisation, combining interventions such as transcranial direct current stimulation (tDCS) and aerobic exercise (AE) to modulate pain-processing circuits may enhance pain control.Methods and analysis A prospective, randomised (1:1:1:1), placebo-controlled, double-blind, factorial clinical trial will test the hypothesis that optimised tDCS (16 anodal tDCS sessions combined with AE) can restore of the pain endogenous control system. Participants with FM (n=148) will undergo a conditioning exercise period and be randomly allocated to one of four groups: (1) active tDCS and AE, (2) sham tDCS and AE, (3) active tDCS and non-aerobic exercise (nAE) or (4) sham tDCS and nAE. Pain inhibitory activity will be assessed using conditioned pain modulation (CPM) and temporal slow pain summation (TSPS)-primary outcomes. Secondary outcomes will include the following assessments: Transcranial magnetic stimulation and electroencephalography as cortical markers of pain inhibitory control and thalamocortical circuits; secondary clinical outcomes on pain, FM, quality of life, sleep and depression. Finally, the relationship between the two main mechanistic targets in this study-CPM and TSPS-and changes in secondary clinical outcomes will be tested. The change in the primary efficacy endpoint, CPM and TSPS, from baseline to week 4 of stimulation will be tested with a mixed linear model and adjusted for important demographic variables.Ethics and dissemination This study obeys the Declaration of Helsinki and was approved by the Institutional Review Board (IRB) of Partners Healthcare under the protocol number 2017P002524. Informed consent will be obtained from participants. Study findings will be reported in conferences and peer-reviewed journal publications.