动机性非指导性共振呼吸与经皮迷走神经刺激治疗纤维肌痛的随机对照试验研究方案。

BACKGROUND: Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM. METHODS: The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life. DISCUSSION: The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited. TRIAL REGISTRATION: ClinicalTrials.gov NCT03180554 . Registered on August 06, 2017.

背景：慢性广泛性疼痛（CWP），包括纤维肌痛（FM），影响十分之一的成年人，是病假和情绪困扰的主要原因之一。由于病因不明和复杂的病理生理学，FM 是一种治疗效果差、安全性低的疾病。然而，目前在迷走神经支配领域的研究表明，FM 可以通过心理生理和电刺激来治疗。本研究将探讨两种不同的非侵入性迷走神经刺激技术治疗 FM 的疗效。

方法：该研究将采用随机、单盲、假对照设计，来调查动机性非直接共振呼吸（MNRB）和经皮迷走神经刺激（Nemos tVNS）对被诊断为 FM 的患者的治疗效果。同意参加该研究的 FM 患者（N=112）将被随机分为四个独立组之一。这些参与者中的一半（N=56）将被随机分配到实验组 tVNS 组或假 tVNS 组。另一半（N=56）将被随机分配到实验组 MNRB 组或假 MNRB 组。实验组和假治疗组都将在家中每天进行两次治疗，每次 15 分钟/上午和 15 分钟/晚上，总疗程为 2 周（14 天）。参与者将被邀请到诊所两次，一次是干预前，一次是干预后收集数据。主要结局是光体积描记法测量的心率变异性的变化。次要结局包括自我报告的数字评分量表上的疼痛强度、疼痛检测阈值、疼痛耐受阈值和计算机压力袖带生物测定法确定的压痛极限的变化、血压和健康相关生活质量的变化。

讨论：本研究描述的随机对照试验旨在比较两种迷走神经支配干预措施，即 MNRB 和 tVNS，对 FM 患者心率变异性和疼痛强度的疗效。该项目测试了一种新的、潜在有效的治疗方法，用于治疗一种流行率高、残疾严重、治疗方法有限的主要公共和全球健康问题。

试验注册：ClinicalTrials.gov NCT03180554。于 2017 年 8 月 6 日注册。