Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study.
Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study.
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DOI：
10.2196/resprot.8692
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发表时间：
2018-02-06
影响因子：
1.7
通讯作者：
Crosson B
中科院分区：
文献类型：
--
作者：
Gebre M;Woodbury A;Napadow V;Krishnamurthy V;Krishnamurthy LC;Sniecinski R;Crosson B
纤维肌痛是一种慢性疼痛状态，包括广泛的肌肉骨骼疼痛、疲劳、精神症状、认知和睡眠障碍以及多种躯体症状。目前的治疗方法往往不足或具有显著的风险，虽然对非药物，特别是非阿片类药物疼痛管理的需求日益增加，例如通过补充和替代药物治疗提供的疼痛管理，但目前没有足够的证据推荐这些治疗方法。经皮电神经刺激（PENS）是一种基于证据的疼痛治疗选择，涉及通过插入皮肤的针头进行电流刺激。耳廓的经皮电神经场刺激（PENFS）类似于PENS，但PENFS不是针对单个神经血管束，而是刺激整个耳朵，覆盖颅神经的所有耳支，包括迷走神经。PENFS缓解纤维肌痛症状的神经机制尚不清楚。我们假设PENFS治疗会降低纤维肌痛患者默认模式网络（DMN）和右后额叶之间的功能性脑连接。我们预计，DMN和DMN之间的功能连接的减少将与患者报告的镇痛改善相关，如国防和退伍军人疼痛评定量表（DVPRS）所示，并将与患者报告的镇痛药物消耗量反相关。将进行探索性分析，以进一步生成假设。来自亚特兰大退伍军人事务医疗中心的共20名被诊断为纤维肌痛的成年人将被随机分为2组：10名受试者进入对照（标准治疗）组，10名受试者进入PENFS治疗组。实用的标准治疗组将包括药物治疗，如抗惊厥药、非甾体抗炎药、局部药物和物理治疗，根据患者的合并症和偏好进行个性化治疗，由疼痛管理医生开具处方。除PENFS治疗外，PENFS组还将包括上述治疗。PENFS受试者组将在耳朵上放置Neuro-Stim系统5天，然后每周取出并更换一次，持续4周。主要结果将是DMN和DMN之间的静息功能磁共振成像连接，这也将与疼痛缓解和功能改善相关。将使用功能连接性磁共振成像（fcMRI）分析这种连接性，并将其与DVPRS和患者报告的镇痛药物消耗所示的患者报告的镇痛改善进行比较。将使用患者报告结果测量信息系统测量以及国际功能残疾和健康分类活动和参与部分描述个人功能状态的测量来进一步评估疼痛和功能。这项试验由退伍军人健康管理计划办公室资助。这项研究获得了埃默里大学/退伍军人事务部（VA）机构审查委员会和VA研究与发展委员会的批准。机构审查委员会于2017年2月7日获得快速批准（IRB 00092224）。研究开始日期为2017年6月1日，预计完成日期为2020年5月31日。招聘于2017年6月开始。这是一项可行性研究，旨在证明使用fcMRI研究PENFS结局的神经相关性的实用性，并提供有关功效计算的信息，以便设计和执行更大的随机对照临床试验，以确定PENFS改善疼痛和功能的疗效。ClinicalTrials.gov NCT 03008837; https://clinicaltrials.gov/ct2/show/NCT03008837（由WebCite在http：//www.webcitation.org/6wrY3NmaQ上存档）。
Fibromyalgia is a chronic pain state that includes widespread musculoskeletal pain, fatigue, psychiatric symptoms, cognitive and sleep disturbances, and multiple somatic symptoms. Current therapies are often insufficient or come with significant risks, and while there is an increasing demand for non-pharmacologic and especially non-opioid pain management such as that offered through complementary and alternative medicine therapies, there is currently insufficient evidence to recommend these therapies. Percutaneous electrical neural stimulation (PENS) is an evidence-based treatment option for pain conditions that involves electrical current stimulation through needles inserted into the skin. Percutaneous electrical neural field stimulation (PENFS) of the auricle is similar to PENS, but instead of targeting a single neurovascular bundle, PENFS stimulates the entire ear, covering all auricular branches of the cranial nerves, including the vagus nerve. The neural mechanisms of PENFS for fibromyalgia symptom relief are unknown. We hypothesize that PENFS treatment will decrease functional brain connectivity between the default mode network (DMN) and right posterior insula in fibromyalgia patients. We expect that the decrease in functional connectivity between the DMN and insula will correlate with patient-reported analgesic improvements as indicated by the Defense and Veterans Pain Rating Scale (DVPRS) and will be anti-correlated with patient-reported analgesic medication consumption. Exploratory analyses will be performed for further hypothesis generation. A total of 20 adults from the Atlanta Veterans Affairs Medical Center diagnosed with fibromyalgia will be randomized into 2 groups: 10 subjects to a control (standard therapy) group and 10 subjects to a PENFS treatment group. The pragmatic, standard therapy group will include pharmacologic treatments such as anticonvulsants, non-steroidal anti-inflammatory drugs, topical agents and physical therapy individualized to patient comorbidities and preferences, prescribed by a pain management practitioner. The PENFS group will include the above therapies in addition to the PENFS treatments. The PENFS subject group will have the Neuro-Stim System placed on the ear for 5 days then removed and replaced once per week for 4 weeks. The primary outcome will be resting functional magnetic resonance imaging connectivity between DMN and insula, which will also be correlated with pain relief and functional improvements. This connectivity will be analyzed utilizing functional connectivity magnetic resonance imaging (fcMRI) and will be compared with patient-reported analgesic improvements as indicated by the DVPRS and patient-reported analgesic medication consumption. Pain and function will be further evaluated using Patient-Reported Outcomes Measurement Information System measures and measures describing a person’s functional status from Activity and Participation section of the International Classification of Functioning Disability and Health. This trial has been funded by the Veterans Health Administration Program Office. This study attained approval by the Emory University/Veterans Affairs (VA) institutional review board and VA Research & Development committee. Institutional review board expedited approval was granted on 2/7/17 (IRB00092224). The study start date is 6/1/17 and estimated completion date is 5/31/20. The recruitment started in June 2017. This is a feasibility study that is meant to demonstrate the practicality of using fcMRI to study the neural correlates of PENFS outcomes and provide information regarding power calculations in order to design and execute a larger randomized controlled clinical trial to determine the efficacy of PENFS for improving pain and function. ClinicalTrials.gov NCT03008837; https://clinicaltrials.gov/ct2/show/NCT03008837 (Archived by WebCite at http://www.webcitation.org/6wrY3NmaQ).