经颅直流电刺激与正念冥想相结合减轻纤维肌痛综合征疼痛：一项随机、双盲、假对照的试点临床试验。

Pain reduction in fibromyalgia syndrome through pairing transcranial direct current stimulation and mindfulness meditation: A randomized, double-blinded, sham-controlled pilot clinical trial.

作者信息

Ramasawmy Perianen, Khalid Sarah, Petzke Frank, Antal Andrea

机构信息

Department of Neurology, University Medical Center Göttingen, Georg-August University, Göttingen, Germany.

Department of Anesthesiology, University Medical Center Göttingen, Georg-August University, Göttingen, Germany.

出版信息

Front Med (Lausanne). 2022 Oct 12;9:908133. doi: 10.3389/fmed.2022.908133. eCollection 2022.

DOI:10.3389/fmed.2022.908133

PMID:36314032

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9596988/

Abstract

BACKGROUND

This double-blinded, randomized and sham-controlled pilot clinical trial aimed to investigate the preliminary clinical efficacy and feasibility of combining mindfulness meditation (MM) and transcranial direct current stimulation (tDCS) for pain and associated symptoms in patients with fibromyalgia syndrome (FMS).

METHODS

Included FMS patients (age: 33 to 70) were randomized to three different groups to receive either ten daily sessions of anodal tDCS over the left primary motor cortex paired with MM for 20 min (active + MM, n = 10), sham tDCS combined with MM (sham + MM, = 10) or no intervention (NoT, = 10). Patients in the bimodal therapy groups received a week of training in MM prior to the stimulation. Participants reported pain intensity, the primary outcome, by filling in a pain diary daily throughout the whole study. They were also evaluated for quality of life, pressure pain sensitivity, psychological wellbeing, sleep quality and sleep quantity. Assessments were performed at three time points (baseline, immediately after treatment and one-month follow-up).

RESULTS

Participants in the active + MM group did not exhibit reduced pain intensity following the bimodal therapy compared to controls. Patients in active group demonstrated clinically meaningful and significantly higher quality of life following the therapeutic intervention than other groups. There was no significant difference among groups regarding pressure pain sensitivity, sleep parameters and psychological scales. The combined treatment was well tolerated among participants, with no serious adverse effects.

CONCLUSION

This study was the first to pair these two effective non-pharmacological therapies for pain management in FMS. In the light of an underpowered sample size, repetitive anodal tDCS combined with MM did not improve pain or FMS-associated symptoms. However, patients in the active + MM group reported higher quality of life than the control groups. Studies with more participants and longer follow-ups are required to confirm our findings.

CLINICAL TRIAL REGISTRATION

[www.drks.de], identifier [DRKS00023490].

摘要

背景

这项双盲、随机、假对照的试点临床试验旨在研究正念冥想（MM）与经颅直流电刺激（tDCS）相结合对纤维肌痛综合征（FMS）患者疼痛及相关症状的初步临床疗效和可行性。

方法

纳入的FMS患者（年龄33至70岁）被随机分为三组，分别接受以下治疗：在左侧初级运动皮层进行为期十天的阳极tDCS治疗，每次治疗同时进行20分钟的MM（主动治疗+MM，n = 10）；假tDCS联合MM治疗（假治疗+MM，n = 10）；或不进行干预（无治疗，n = 10）。双峰治疗组的患者在刺激前接受了为期一周的MM训练。在整个研究过程中，参与者每天通过填写疼痛日记报告疼痛强度这一主要结局。他们还接受了生活质量、压痛敏感性、心理健康、睡眠质量和睡眠时间的评估。在三个时间点（基线、治疗后立即和随访一个月）进行评估。