经皮迷走神经刺激疗法对反复疼痛热刺激感知强度的影响：一项盲安慰剂和假刺激对照随机交叉研究
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Effects of Electrical Transcutaneous Vagus Nerve Stimulation on the Perceived Intensity of Repetitive Painful Heat Stimuli: A Blinded Placebo- and ShamControlled Randomized Crossover Investigation
背景与目的
经皮迷走神经刺激（TVNS）是治疗急性和慢性疼痛一种有前景的治疗方法。然而，实验研究的结果有争议。我们研究TVNS与安慰剂和假刺激组相比，是否减少了健康志愿者对疼痛刺激的感知强度和疼痛总时长（TSP）。
方 法
共49名健康志愿者（25名女性）在4个疗程里使用了接触式的热诱发电位刺激电极 (Medoc, Ramat Yishai, Israel).，以个人能耐受疼痛的90个热脉冲来刺激实验对象的腹侧前臂。每10个热脉冲使用一次疼痛数字表（0-100）对疼痛的强度进行口头评估。在第一次没有干预的治疗并进行疼痛强度评估后，参与者以单盲随机交叉方式完成后3个疗程的治疗，即：（1）用在耳垂上的假刺激，（2）安慰剂刺激（闲置设备），或者（3）在外耳上应用TVNS。对重复测量的原始数据采用方差分析，并对成对样本采用t检验。
结 果
与不干预组相比，所有采取干预措施的小组疼痛强度都有所下降（ηp 2=0.22，P<.001;平均差TVNS组与不干预组相比为9.5;95% CI：3.6-15.4;P <.001)。
在TSP开始前使用，TVNS降低痛觉的效果比安慰剂和假刺激组的效果好（TVNS与安慰剂相比平均差为6.2;95%CI,0.2 - 12.1;TVNS和假刺激组比为6.2;95%CI,0.2 - 12.1;P < . 05)。而对于女性实验者，如果与无干预组相比（中位数差异为7.5;95%CI,3.5 - 15.0;P = .003)。
结 论
在实验热疼痛刺激下，TVNS、安慰剂和假刺激产生了类似的效果。只有男性实验对象在TSP开始前减轻热痛的效果是TVNS优于安慰剂和假刺激组的。
原始文献摘要
BACKGROUND: Transcutaneous vagus nerve stimulation (TVNS) is a promising treatment for acute and chronic pain. However, experimental studies yielded controversial results. We examined if TVNS reduces the perceived intensity of repetitive painful heat stimulation and temporal summation of pain (TSP) in healthy volunteers in comparison with placebo and sham stimulation, as well as no intervention.
METHODS: In 4 sessions, 90 heat pulse stimuli at individual pain tolerance temperature were applied to the ventral forearm of 49 healthy volunteers (25 women) using a Contact Heat Evoked Potential Stimulator thermode (Medoc, Ramat Yishai, Israel). Pain intensity was assessed with verbal ratings on a numeric pain scale (0 100) at every tenth heat pulse. After the first session in which pain intensities without intervention were evaluated, participants completed 3 sessions in a single-blinded randomized crossover manner: (1) sham stimulation applied at the earlobes, (2) placebo stimulation (inactive device), or (3) TVNS applied at the cymbas conchae. Primary data were analyzed using analysis of variance for repeated measures and t test for paired samples.
RESULTS: Pain intensity decreased during all interventions as compared to no intervention (ηp 2 = 0.22, P < .001; mean difference TVNS versus no intervention 9.5; 95% confidence interval [CI], 3.6 15.4; P < .001). Hypoalgesic effect of TVNS was better than that of placebo and sham in men before the onset of TSP (mean differences for TVNS versus placebo 6.2; 95% CI, 0.2 12.1; TVNS versus sham 6.2; 95% CI, 0.2 12.1; P < .05). In women, TSP response under TVNS was decreased if compared to no intervention (median difference, 7.5; 95% CI, 3.5 15.0; P = .003).
CONCLUSIONS: TVNS, placebo, and sham stimulation exerted comparable effects under experimental
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