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Abstract：
To evaluate the feasibility of recruitment, preliminary efficacy, and acceptability of auricular percutaneous electrical nerve field stimulation (PENFS) for the treatment of fibromyalgia in veterans, using neuroimaging as an outcome measure and a biomarker of treatment response.
Randomized, controlled, single-blind.
Government hospital.
Twenty-one veterans with fibromyalgia were randomized to standard therapy (ST) control or ST with auricular PENFS treatment.
Participants received weekly visits with a pain practitioner over 4 weeks. The PENFS group received reapplication of PENFS at each weekly visit. Resting-state functional connectivity magnetic resonance imaging (rs-fcMRI) data were collected within 2 weeks prior to initiating treatment and 2 weeks following the final treatment. Analysis of rs-fcMRI used a right posterior insula seed. Pain and function were assessed at baseline and at 2, 6, and 12 weeks post-treatment.
At 12 weeks post-treatment, there was a nonsignificant trend toward improved pain scores and significant improvements in pain interference with sleep among the PENFS treatment group as compared with the ST controls. Neuroimaging data displayed increased connectivity to areas of the cerebellum and executive control networks in the PENFS group as compared with the ST control group following treatment.
There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control group. Pain and functional outcomes correlated with altered rs-fcMRI network connectivity. Neuroimaging results differed between groups, suggesting an alternative underlying mechanism for PENFS analgesia.
Randomized, controlled, single-blind.
Government hospital.
Twenty-one veterans with fibromyalgia were randomized to standard therapy (ST) control or ST with auricular PENFS treatment.
Participants received weekly visits with a pain practitioner over 4 weeks. The PENFS group received reapplication of PENFS at each weekly visit. Resting-state functional connectivity magnetic resonance imaging (rs-fcMRI) data were collected within 2 weeks prior to initiating treatment and 2 weeks following the final treatment. Analysis of rs-fcMRI used a right posterior insula seed. Pain and function were assessed at baseline and at 2, 6, and 12 weeks post-treatment.
At 12 weeks post-treatment, there was a nonsignificant trend toward improved pain scores and significant improvements in pain interference with sleep among the PENFS treatment group as compared with the ST controls. Neuroimaging data displayed increased connectivity to areas of the cerebellum and executive control networks in the PENFS group as compared with the ST control group following treatment.
There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control group. Pain and functional outcomes correlated with altered rs-fcMRI network connectivity. Neuroimaging results differed between groups, suggesting an alternative underlying mechanism for PENFS analgesia.
摘要：
评估招聘的可行性，初步疗效,耳部经皮神经电场刺激（PENFS）治疗退伍军人纤维肌痛的可接受性，使用神经影像学作为结果测量和治疗反应的生物标志物。
随机化，控制,单盲。
政府医院。
21名患有纤维肌痛的退伍军人被随机分为标准治疗（ST）对照或ST耳廓PENFS治疗。
参与者在4周内每周接受疼痛医生的访问。PENFS组在每次每周访问时都会重新申请PENFS。在开始治疗前2周内和最终治疗后2周内收集静息状态功能连接磁共振成像（rs-fcMRI）数据。rs-fcMRI分析使用右后岛叶种子。在基线和治疗后2、6和12周评估疼痛和功能。
治疗后12周，与ST对照组相比,PENFS治疗组的疼痛评分改善和睡眠疼痛干扰显著改善趋势不显著.神经影像学数据显示，与治疗后的ST对照组相比，PENFS组与小脑和执行控制网络区域的连通性增加。
与ST对照组相比，ST+PENFS组的纤维肌痛退伍军人的疼痛和功能有改善的趋势。疼痛和功能结局与rs-fcMRI网络连接改变相关。组间神经影像学检查结果不同,提示PENFS镇痛的另一种潜在机制。
随机化，控制,单盲。
政府医院。
21名患有纤维肌痛的退伍军人被随机分为标准治疗（ST）对照或ST耳廓PENFS治疗。
参与者在4周内每周接受疼痛医生的访问。PENFS组在每次每周访问时都会重新申请PENFS。在开始治疗前2周内和最终治疗后2周内收集静息状态功能连接磁共振成像（rs-fcMRI）数据。rs-fcMRI分析使用右后岛叶种子。在基线和治疗后2、6和12周评估疼痛和功能。
治疗后12周，与ST对照组相比,PENFS治疗组的疼痛评分改善和睡眠疼痛干扰显著改善趋势不显著.神经影像学数据显示，与治疗后的ST对照组相比，PENFS组与小脑和执行控制网络区域的连通性增加。
与ST对照组相比，ST+PENFS组的纤维肌痛退伍军人的疼痛和功能有改善的趋势。疼痛和功能结局与rs-fcMRI网络连接改变相关。组间神经影像学检查结果不同,提示PENFS镇痛的另一种潜在机制。
