"Pain Relief for Office Hysteroscopy: A Randomized Controlled Trial Comparing a Transcutaneous Electric Nerve Stimulation and Placebo

Abstract
Background: The efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-invasive method for pain management during office-based hysteroscopy requires additional investigation.
Objective: To evaluate the analgesic effects of transcutaneous electrical nerve stimulation (TENS) in office hysteroscopy procedures and the level of patient satisfaction with this intervention.
Patients and Methods:
The study employed a double-blind randomized controlled trial design, which included a sample of 120 female participants who underwent office hysteroscopy. The participants were categorized into two groups: the TENS group (N = 60) received active transcutaneous electrical nerve stimulation (TENS) during office hysteroscopy using a health tronic alpha wave TENS instrument (Model MB - 1004) with four large pads, two channels, two leads, a pulse width of 200 µs, and a pulse frequency ranging from 40 to 100 Hz. The Placebo group (N = 60) received placebo TENS during office hysteroscopy.

Results: Following the hysteroscopy procedure at the office, both the TENS and placebo study groups exhibited comparable levels of pain, with no statistically significant differences observed in terms of the Visual Analogue Scale (VAS) assessment (p = 0.311) and the intensity of pain (p = 0.11). No statistically significant difference was seen in the satisfaction rating between the two groups when using the verbal Likert scale (p = 0.351). The study found a significant positive correlation between the VAS score and the age (r = 0.256, P <0.001) as well as the parity (r = 0.404, p <0.001). Conversely, a negative correlation was seen between the VAS score and the participants' height (r = -0.317, p <0.001) and Likert verbal scale (r = -0.278, p <0.001).
Conclusion: The TENS device does not provide a substantial alleviation of the pain linked to office hysteroscopy
Keywords: Hysteroscopy, TENS, Pain.

摘要
背景：经皮神经电刺激（transcutaneous electrical nerve stimulation, TENS）作为门诊宫腔镜手术中非侵入性疼痛管理手段，其临床疗效仍有待进一步探究。
目的：评估经皮神经电刺激（TENS）在门诊宫腔镜手术中的镇痛效果，以及患者对该干预措施的满意度水平。
患者与方法：本研究采用双盲随机对照试验设计，纳入120名接受门诊宫腔镜手术的女性受试者，将其随机分为两组：TENS组（N=60）在手术期间使用health tronic alpha波TENS设备（型号MB-1004）接受主动经皮神经电刺激，该设备配备4个大电极片、2个通道、2根导线，脉冲宽度为200微秒，脉冲频率范围为40~100Hz；安慰剂组（N=60）在手术期间接受安慰剂经皮神经电刺激。
结果：门诊宫腔镜手术后，TENS组与安慰剂组的疼痛程度无显著统计学差异，视觉模拟评分法（Visual Analogue Scale, VAS）评估结果（p=0.311）与疼痛强度（p=0.11）均无统计学意义。采用口头李克特评分量表评估时，两组患者的满意度评分亦无显著统计学差异（p=0.351）。本研究发现，VAS评分与年龄（r=0.256，P<0.001）及孕产次数（r=0.404，p<0.001）呈显著正相关；反之，VAS评分与受试者身高（r=-0.317，p<0.001）及口头李克特评分量表得分（r=-0.278，p<0.001）呈显著负相关。
结论：经皮神经电刺激设备无法显著缓解门诊宫腔镜手术相关疼痛。
关键词：宫腔镜手术，经皮神经电刺激（TENS），疼痛。