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不同频率重复经颅磁刺激治疗带状疱疹后神经痛的双盲、假刺激随机对照试验。

Repetitive Transcranial Magnetic Stimulation at Different Frequencies for Postherpetic Neuralgia: A Double-Blind, Sham-Controlled, Randomized Trial.

机构信息

Department of Pain Management, Xuanwu Hospital Capital Medical University, Beijing, China; Beijing Jishuitan Hospital, Beijing, China.

Department of Pain Management, Xuanwu Hospital Capital Medical University, Beijing, China.

出版信息

Pain Physician. 2019 Jul;22(4):E303-E313.

PMID:31337172
Abstract

BACKGROUND

Repetitive transcranial magnetic stimulation (rTMS) at 5 Hz and 10 Hz is effective in improving pain, sleep quality, and anxiety among patients with postherpetic neuralgia (PHN). But it has not been reported which frequency is more effective and which frequency is safer.

OBJECTIVES

This study aimed to observe the efficacy and safety of rTMS at different high frequencies (5 Hz, 10 Hz) for PHN.

STUDY DESIGN

The design of the study was a prospective randomized, controlled clinical trial.

SETTING

The research was conducted within a department of pain management at a university hospital in China.

METHODS

Sixty patients with PHN who were treated at the Department of Pain Management at Xuanwu Hospital of Capital Medical University were recruited. Using a computer-created number list, the cases were equally divided into 3 groups (n = 20), namely, the sham rTMS group, 5-Hz rTMS group, and 10-Hz rTMS group. The sham rTMS group received sham stimulation, and the other 2 groups received high-frequency (5-Hz and 10-Hz) rTMS, respectively. The primary motor cortex (M1) on the healthy side was stimulated with an intensity of 80% transcranial magnetic stimulation (RMT). For the 5-Hz rTMS group, each stimulation session consisted of a series of 300 one-second pulses with a frequency of 5 Hz and an interval of 2.5 seconds between each train, giving a total of 1500 pulses per session. For the 10-Hz rTMS group, each stimulation session consisted of a series of 300 0.5-second pulses with a frequency of 10 Hz and an interval of 3 seconds between each train, giving a total of 1500 pulses per session; the total time of stimulations was 17.5 minutes. rTMS was performed once daily for 10 days. The 3 groups received conventional medication therapy. Baseline data (gender, age, course of disease, affected side) were recorded in the 3 groups. At different time points (before treatment, T0; during treatment, T1-T10; 1 month after treatment, T11; and 3 months after treatment, T12), the patients were evaluated on the following scales: Visual Analog Scale (VAS), short-form McGill Pain Questionnaire (SF-MPQ), Quality of Life (QOL) scale, sleep quality (SQ) scale, Self-Rating Depression Scale (SDS), Patient Global Impression of Change (PGIC), and incidence of adverse events.

RESULTS

Compared with the sham rTMS group, there was a significant reduction in VAS scores in the 5-Hz rTMS group and 10-Hz rTMS group at T2-T12 (P < .05). VAS scores in the 10-Hz rTMS group at T7-T12 were significantly lower compared with the 5-Hz rTMS group (P < .05). The average VAS reduction was significantly different between the 5-Hz and 10-Hz rTMS groups; 28.3% (95% confidence interval [CI],19.48%-49.35%), compared to 39.89% (95% CI, 22.47%-58.64%), with (F = 5.289, P = .022). The 3 groups did not differ significantly in general SF-MPQ, QOL, SQ, SDS, and PGIC scores. However, the QQL, SQ, and PGIC scores of the 5-Hz rTMS group and the 10-HZ rTMS group at T12 were significantly higher than that of the sham rTMS group.

LIMITATIONS

The study's follow-up period was limited to 3 months.

CONCLUSIONS

rTMS at either frequency, 5 Hz or 10 Hz, relieved PHN and improved the patients' quality of life. rTMS at 10 Hz was superior to rTMS at 5 Hz in terms of pain relief, quality of life, and improvement in sleep quality, though the latter had higher safety. rTMS at either 5 Hz or 10 Hz can be used as an adjuvant therapy for PHN.

KEY WORDS

Repetitive transcranial magnetic stimulation, postherpetic neuralgia, pain evaluation.

摘要

背景

5 Hz 和 10 Hz 的重复经颅磁刺激(rTMS)在改善带状疱疹后神经痛(PHN)患者的疼痛、睡眠质量和焦虑方面是有效的。但是,哪种频率更有效,哪种频率更安全,尚未有报道。

目的

本研究旨在观察不同高频(5 Hz、10 Hz)rTMS 治疗 PHN 的疗效和安全性。

研究设计

研究设计为前瞻性随机对照临床试验。

设置

研究在一家中国大学医院的疼痛管理科进行。

方法

共招募了 60 名在首都医科大学宣武医院疼痛科就诊的 PHN 患者。采用计算机生成的数字列表,将病例平均分为 3 组(n = 20),即假刺激 rTMS 组、5 Hz rTMS 组和 10 Hz rTMS 组。假刺激 rTMS 组接受假刺激,另外 2 组分别接受高频(5 Hz 和 10 Hz)rTMS。健康侧的初级运动皮层(M1)用 80%经颅磁刺激(RMT)强度进行刺激。对于 5 Hz rTMS 组,每个刺激疗程由一系列 300 个 1 秒脉冲组成,频率为 5 Hz,每个训练之间的间隔为 2.5 秒,每个疗程共 1500 个脉冲。对于 10 Hz rTMS 组,每个刺激疗程由一系列 300 个 0.5 秒脉冲组成,频率为 10 Hz,每个训练之间的间隔为 3 秒,每个疗程共 1500 个脉冲;总刺激时间为 17.5 分钟。rTMS 每天进行一次,共 10 天。3 组均接受常规药物治疗。记录 3 组的基线数据(性别、年龄、病程、受累侧)。在不同时间点(治疗前,T0;治疗期间,T1-T10;治疗后 1 个月,T11;治疗后 3 个月,T12),采用视觉模拟量表(VAS)、简化 McGill 疼痛问卷(SF-MPQ)、生活质量(QOL)量表、睡眠质量(SQ)量表、自评抑郁量表(SDS)、患者总体印象变化量表(PGIC)和不良事件发生率对患者进行评估。

结果

与假刺激 rTMS 组相比,5 Hz rTMS 组和 10 Hz rTMS 组在 T2-T12 时 VAS 评分显著降低(P <.05)。T7-T12 时 10 Hz rTMS 组的 VAS 评分明显低于 5 Hz rTMS 组(P <.05)。5 Hz rTMS 组和 10 Hz rTMS 组之间的平均 VAS 降低差异有统计学意义;28.3%(95%置信区间[CI],19.48%-49.35%),与 39.89%(95% CI,22.47%-58.64%)相比,(F = 5.289,P =.022)。3 组的一般 SF-MPQ、QOL、SQ、SDS 和 PGIC 评分无显著差异。然而,5 Hz rTMS 组和 10 Hz rTMS 组在 T12 时的 QQL、SQ 和 PGIC 评分明显高于假刺激 rTMS 组。

局限性

研究的随访时间限于 3 个月。

结论

rTMS 频率为 5 Hz 或 10 Hz 均可缓解 PHN 并改善患者生活质量。10 Hz rTMS 在缓解疼痛、提高生活质量和改善睡眠质量方面优于 5 Hz rTMS,尽管后者安全性更高。rTMS 频率为 5 Hz 或 10 Hz 均可作为 PHN 的辅助治疗。

关键词

重复经颅磁刺激;带状疱疹后神经痛;疼痛评估。

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