脊髓损伤后神经性疼痛患者中，背外侧前额叶皮层与运动皮层重复经颅磁刺激的效果：一项研究方案。
Effects of repeated transcranial magnetic stimulation in the dorsolateral prefrontal cortex versus motor cortex in patients with neuropathic pain after spinal cord injury: a study protocol.
作者信息
Huang Maomao, Luo Xi, Zhang Chi, Xie Yu-Jie, Wang Li, Wan Tenggang, Chen Ruyan, Xu Fangyuan, Wang Jian-Xiong
机构信息
Department of Rehabilitation, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.
Laboratory of Neurological Disease and Brain Function, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.
出版信息
BMJ Open. 2022 Mar 11;12(3):e053476. doi: 10.1136/bmjopen-2021-053476.
INTRODUCTION
Neuropathic pain is one of the common complications of spinal cord injuries (SCI), which will slow down the recovery process and result in lower quality of life. Previous studies have shown that repeated transcranial magnetic stimulation (rTMS) of the motor cortex (M1) can reduce the average pain and the most severe pain of neuropathic pain after SCI. The dorsolateral prefrontal cortex (DLPFC) area is a common target of rTMS. Recently, a few studies found that rTMS of DLPFC may relieve the neuropathic pain of SCI. Compared with the M1 area, the efficacy of rTMS treatment in the DLPFC area in improving neuropathic pain and pain-related symptoms in patients with SCI is still unclear. Therefore, our study aims to evaluate the non-inferiority of rTMS in the DLPFC vs M1 in patients with neuropathic pain after SCI, in order to provide more options for rTMS in treating neuropathic pain after SCI.
METHODS AND ANALYSIS
We will recruit 50 subjects with neuropathic pain after SCI. They will be randomly assigned to the DLPFC- rTMS and M1-rTMS groups and be treated with rTMS for 4 weeks. Except for the different stimulation sites, the rTMS treatment programmes of the two groups are the same: 10 Hz, 1250 pulses, 115% intensity threshold, once a day, five times a week for 4 weeks. VAS, simplified McGill Pain Questionnaire, Spinal Cord Injury Pain Date Set, Pittsburgh Sleep Quality Index and Hamilton Anxiety Scale will be evaluated at baseline, second week of treatment, fourth week of treatment and 4 weeks after the end of treatment. And VAS change will be calculated.
ETHICS AND DISSEMINATION
The Ethics Committee of the Affiliated Hospital of Southwest Medical University has approved this trial, which is numbered KY2020041. Written informed consent will be provided to all participants after verification of the eligibility criteria. The results of the study will be published in peer-reviewed publications.
TRIAL REGISTRATION NUMBER
ChiCTR2000032362.
引言
神经性疼痛是脊髓损伤（SCI）常见的并发症之一，它会减缓恢复进程并导致生活质量下降。先前的研究表明，对运动皮层（M1）进行重复经颅磁刺激（rTMS）可以减轻SCI后神经性疼痛的平均疼痛程度和最严重疼痛程度。背外侧前额叶皮层（DLPFC）区域是rTMS的常见靶点。最近，一些研究发现对DLPFC进行rTMS可能会缓解SCI的神经性疼痛。与M1区域相比，rTMS治疗DLPFC区域对改善SCI患者神经性疼痛及疼痛相关症状的疗效仍不明确。因此，我们的研究旨在评估rTMS治疗SCI后神经性疼痛患者时，DLPFC区域与M1区域相比的非劣效性，以便为rTMS治疗SCI后神经性疼痛提供更多选择。
方法与分析
我们将招募50例SCI后神经性疼痛患者。他们将被随机分配到DLPFC-rTMS组和M1-rTMS组，并接受4周的rTMS治疗。除刺激部位不同外，两组的rTMS治疗方案相同：10赫兹，1250个脉冲，强度阈值为115%，每天一次，每周五次，共4周。将在基线、治疗第二周、治疗第四周以及治疗结束后4周评估视觉模拟评分法（VAS）、简化麦吉尔疼痛问卷、脊髓损伤疼痛数据集、匹兹堡睡眠质量指数和汉密尔顿焦虑量表。并计算VAS变化。
伦理与传播
西南医科大学附属医院伦理委员会已批准本试验，编号为KY2020041。在核实入选标准后，将向所有参与者提供书面知情同意书。研究结果将发表在同行评审的出版物上。
试验注册号
ChiCTR2000032362。
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