背景:经皮神经电刺激(TENS)是一种非侵入性方式,利用电流调节急性和慢性疼痛人群的疼痛。TENS已被证明在术后疼痛中产生痛觉减退作用,纤维肌痛,膝骨关节炎,和健康的受试者。经皮耳廓迷走神经刺激(TaVNS)是通过刺激其耳廓分支来调节迷走神经的非侵入性方式。尚未研究TENS和TaVNS的组合对产生镇痛反应的影响。考虑到TENS和TaVNS都刺激相似的镇痛途径,但通过不同的激活方式,我们可以假设两种方法的组合可以产生更明显的镇痛反应.因此,本研究的目的是评估TENS和TaVNS联合治疗在无痛受试者中的痛觉减退效应.
方法:该研究将是在哈特福德大学进行的简单交叉设计。受试者将通过口头交流从哈特福德大学招募,数字传单,校园里的海报。30名参与者将以交叉的方式进行两次会议,中间一周。在一次会议期间,参与者将接受TENS与活跃的TaVNS和其他会话将是安慰剂程序(TENS与安慰剂TaVNS).这些会话的顺序将是随机的。重要的是,压力痛阈值(PPT)和热痛阈值(HPT)评估员将不了解治疗类别.对于活动的TaVNS,将施加25Hz的频率,脉冲持续时间为200µs。对于安慰剂TaVNS,强度将增加到感觉水平,然后降低到0mA。100Hz的高频TENS将在两个会话中应用,脉冲持续时间为200μsec,不对称双相方波,和没有疼痛的最大耐受强度。在基线测量结果后,TENS和TaVNS将打开30分钟。然后将关闭TENS和TaVNS,但电极将保持接通,直到完成治疗后评估。压力痛阈值,热痛阈值,血压,氧饱和度,心率将被测试4次:一旦预先干预,一旦在干预期间,一旦在干预后立即,并在干预后15分钟进行一次。获得的数据的统计学分析将考虑p<0.05的显著性水平。
结论:本研究将提供有关TENS和TaVNS对无痛参与者的痛阈联合作用的证据。根据结果,更好地理解TENS和TaVNS,当连用时,可以调节疼痛途径。
背景:ClinicalTrials.govNCT06361381。2024年4月9日注册。
BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, we can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects.
METHODS: The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High-frequency TENS of 100 Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 min after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation, and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention, and once 15 min post-intervention. Statistical analysis of the data obtained will consider a significance level of p < 0.05.
CONCLUSIONS: This study will provide evidence concerning the combined effects of TENS and TaVNS on pain threshold in pain-free participants. Based on the outcomes, a greater understanding of how TENS and TaVNS, when used in conjunction, can modulate pain pathways.
BACKGROUND: ClinicalTrials.gov NCT06361381. Registered on 09 April 2024.