Department of Medicine, Michigan State University College of Human Medicine, East Lansing, Michigan 48504-6214, USA.
Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x.
The aim of this multicenter study was to evaluate the efficacy, safety, and tolerability of noninvasive cortical electrostimulation in the management of fibromyalgia (FM).
A prospective, randomized, double-blind, placebo-controlled design was used. Setting. Subjects received therapy at two different outpatient clinical locations.
There were 77 subjects meeting the American College of Rheumatology 1990 classification criteria for FM. Intervention. Thirty-nine (39) active treatment (AT) FM patients and 38 placebo controls received 22 applications of either noninvasive cortical electrostimulation or a sham therapy over an 11-week period.
The primary outcome measures were the number of tender points (TePs) and pressure pain threshold (PPT). Secondary outcome measures were responses to the Fibromyalgia Impact Questionnaire (FIQ), Symptom Checklist-90 (SCL-90), Beck Depression Inventory-II, and a novel sleep questionnaire, all evaluated at baseline and at the end of treatment.
Intervention provided significant improvements in TeP measures: compared with placebo, the AT patients improved in the number of positive TePs (-7.4 vs -0.2, P<0.001) and the PPT (19.6 vs -3.2, P<0.001). Most secondary outcomes also improved more in the AT group: total FIQ score (-15.5 vs -5.6, P=0.03), FIQ pain (-2.0 vs -0.6, P=0.03), FIQ fatigue (-2.0 vs -0.4, P=0.02), and FIQ refreshing sleep (-2.1 vs -0.7, P=0.02); and while FIQ function improved (-1.0 vs -0.2), the between-group change had a 14% likelihood of occurring due to chance (P=0.14). There were no significant side effects observed.
Noninvasive cortical electrostimulation in FM patients provided modest improvements in pain, TeP measures, fatigue, and sleep; and the treatment was well tolerated. This form of therapy could potentially provide worthwhile adjunctive symptom relief for FM patients.
本多中心研究旨在评估无创皮层电刺激治疗纤维肌痛（FM）的疗效、安全性和耐受性。
采用前瞻性、随机、双盲、安慰剂对照设计。地点：受试者在两个不同的门诊临床地点接受治疗。
共有 77 名符合美国风湿病学院 1990 年纤维肌痛分类标准的患者。干预：39 名（39 名）主动治疗（AT）FM 患者和 38 名安慰剂对照患者在 11 周内接受 22 次无创皮层电刺激或假治疗。
主要观察指标为压痛点数（TePs）和压痛阈值（PPT）。次要观察指标为纤维肌痛影响问卷（FIQ）、症状清单-90（SCL-90）、贝克抑郁量表-II 和一项新的睡眠问卷的反应，所有指标均在基线和治疗结束时进行评估。
干预措施在 TeP 测量方面有显著改善：与安慰剂相比，AT 患者的阳性 TeP 数（-7.4 对-0.2，P<0.001）和 PPT（19.6 对-3.2，P<0.001）均有所改善。大多数次要结局在 AT 组中也有更大的改善：总 FIQ 评分（-15.5 对-5.6，P=0.03）、FIQ 疼痛（-2.0 对-0.6，P=0.03）、FIQ 疲劳（-2.0 对-0.4，P=0.02）和 FIQ 清爽睡眠（-2.1 对-0.7，P=0.02）；虽然 FIQ 功能有所改善（-1.0 对-0.2），但两组之间的变化有 14%的可能性是由于偶然发生的（P=0.14）。未观察到明显的副作用。
无创皮层电刺激治疗纤维肌痛患者在疼痛、TeP 测量、疲劳和睡眠方面提供了适度的改善，且治疗耐受性良好。这种治疗方法可能为纤维肌痛患者提供有价值的辅助症状缓解。
