Institute of Systems Neurosciences, University Hospital Eppendorf, Martinistr,52, 20246 Hamburg, Germany.
BMC Musculoskelet Disord. 2011 Dec 28;12:290. doi: 10.1186/1471-2474-12-290.
Electrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief. To avoid the risks and side effects of surgery, transcranial direct current stimulation is an option to electrically stimulate the motor cortex through the skull. Previous research has shown that transcranial direct current stimulation relieves pain in patients with fibromyalgia, chronic neuropathic pain and chronic pelvic pain. Evidence indicates that the method is pain free, safe and inexpensive.
METHODS/DESIGN: A randomised controlled trial has been designed to evaluate the effect of transcranial direct current stimulation over the motor cortex for pain reduction in patients with chronic low back pain. It will also investigate whether transcranial direct current stimulation as a prior treatment enhances the symptom reduction achieved by a cognitive-behavioural group intervention. Participants will be randomised to receive a series of 5 days of transcranial direct current stimulation (2 mA, 20 mins) or 20 mins of sham stimulation; followed by a cognitive-behavioural group programme. The primary outcome parameters will measure pain (Visual Analog Scale) and disability (Oswestry Disability Index). Secondary outcome parameters will include the Fear Avoidance Beliefs Questionnaire, the Funktionsfragebogen Hannover (perceived function), Hospital Anxiety Depression Scale, bothersomeness and Health Related Quality of Life (SF 36), as well as Patient-Perceived Satisfactory Improvement. Assessments will take place immediately prior to the first application of transcranial direct current stimulation or sham, after 5 consecutive days of stimulation, immediately after the cognitive-behavioural group programme and at 4 weeks, 12 weeks and 24 weeks follow-up.
This trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back pain and whether it can further enhance the effects of a cognitive behavioural pain management programme.
通过手术植入刺激器对中枢神经系统区域进行电刺激已被证明可以缓解疼痛。为了避免手术的风险和副作用，经颅直流电刺激是一种通过颅骨刺激运动皮层的选择。先前的研究表明，经颅直流电刺激可缓解纤维肌痛、慢性神经性疼痛和慢性盆腔疼痛患者的疼痛。有证据表明，该方法无痛苦、安全且廉价。
方法/设计：已设计一项随机对照试验，以评估经颅直流电刺激运动皮层对慢性腰痛患者减轻疼痛的效果。它还将研究经颅直流电刺激作为预先治疗是否增强认知行为组干预所达到的症状缓解。参与者将被随机分配接受一系列 5 天的经颅直流电刺激（2 mA，20 分钟）或 20 分钟的假刺激；然后进行认知行为组方案。主要结局参数将测量疼痛（视觉模拟量表）和残疾（Oswestry 残疾指数）。次要结局参数将包括恐惧回避信念问卷、汉诺威功能问卷（感知功能）、医院焦虑抑郁量表、烦恼和健康相关生活质量（SF-36），以及患者感知的满意改善。评估将在第一次经颅直流电刺激或假刺激前、连续 5 天刺激后、认知行为组方案后立即以及 4 周、12 周和 24 周随访时进行。
该试验将有助于确定经颅直流电刺激是否是慢性腰痛患者的有效治疗方法，以及它是否可以进一步增强认知行为疼痛管理方案的效果。
