Department of Psychology and Philosophy, Sam Houston State University, Huntsville, TX 77341, USA.
Pain Med. 2010 Jun;11(6):912-9. doi: 10.1111/j.1526-4637.2010.00862.x.
OBJECTIVE: To evaluate the efficacy of a novel variant of electroencephalograph biofeedback, the Low Energy Neurofeedback System (LENS), that utilizes minute pulses of electromagnetic stimulation to change brainwave activity for the amelioration of fibromyalgia (FM) symptoms. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Tertiary referral academic medical center, outpatient. PATIENTS: Thirty-four patients diagnosed with FM according to 1990 American College of Rheumatology classification criteria. INTERVENTIONS: Active or sham LENS, depending on randomization, for 22 treatment sessions. OUTCOME MEASURES: Primary outcome measure was the Fibromyalgia Impact Questionnaire total score. Secondary outcome measures included number of tender points (TPs) and pressure required to elicit TPs on physical examination, quantitative sensory testing heat pain threshold, and self-reported cognitive dysfunction, fatigue, sleep problems, global psychological distress, and depression obtained at baseline, immediate post-treatment, and 3- and 6-month follow-up. RESULTS: Participants who received the active or sham interventions improved (Ps < 0.05) on the primary and a variety of secondary outcome measures, without statistically significant between group differences in evidence at post-treatment or 3- or 6-month follow-up. Individual session self-reported ratings of specific symptoms (cognitive dysfunction, fatigue, pain, and sleep, and overall activity level) over the course of the 22 intervention sessions indicated significant linear trends for improvement for the active intervention condition only (Ps < 0.05). CONCLUSION: LENS cannot be recommended as a single modality treatment for FM. However, further study is warranted to investigate the potential of LENS to interact synergistically with other pharmacologic and nonpharmacologic therapies for improving symptoms in FM.
目的:评估一种新型脑电图生物反馈变体——低能量神经反馈系统(LENS)的疗效,该系统利用微小的电磁刺激脉冲来改变脑电波活动,以改善纤维肌痛(FM)症状。
设计:随机、双盲、安慰剂对照临床试验。
地点:三级转诊学术医疗中心,门诊。
患者:根据 1990 年美国风湿病学会分类标准诊断为 FM 的 34 名患者。
干预:根据随机分组,接受主动或假 LENS 治疗,共 22 个疗程。
主要结局指标:主要结局指标是纤维肌痛影响问卷总分。次要结局指标包括压痛点数(TPs)和体格检查时引出 TPs 的压力、定量感觉测试热痛阈值以及自我报告的认知功能障碍、疲劳、睡眠问题、总体心理困扰和抑郁,这些指标在基线、即刻治疗后以及 3 个月和 6 个月随访时获得。
结果:接受主动或假干预的参与者在主要和各种次要结局指标上均有所改善(P < 0.05),但在治疗后或 3 个月和 6 个月随访时,两组之间没有统计学上显著的差异。在 22 个干预疗程中,个体疗程自我报告的特定症状(认知功能障碍、疲劳、疼痛和睡眠以及整体活动水平)的特定症状评分表明,主动干预条件下存在显著的线性改善趋势(P < 0.05)。
结论:LENS 不能作为 FM 的单一治疗模式推荐。然而,需要进一步研究以探讨 LENS 与其他药物和非药物疗法协同作用的潜力,以改善 FM 的症状。
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