Departments of Medicine, Physiotherapy, and Surgery, Universidad CEU Cardenal Herrera, Valencia, and the School of Nursing and the Department of Gynecology, Hospital Provincial de Castellón, Castellón, Spain.
Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.
To evaluate the pain-relieving effect of transcutaneous electrical nerve stimulation (TENS) during office-based hysteroscopy without sedation.
We conducted a randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to the active TENS, placebo TENS, or control group. The active TENS intervention consisted of a varying high-frequency (80-100 Hz), 400-microseconds, individually adjusted, high-intensity TENS application with two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels. In the placebo group, participants were connected to the TENS unit but delivering no electrical stimulation. The primary outcome was self-reported pain intensity (0-100 mm) measured on a visual analog scale at several stages (entry, contact, biopsy, and residual). The minimum clinically relevant difference for the visual analog scale has been previously reported as 10 mm. Sample size was calculated to provide 80% power to show a 10-mm difference (α=0.0125) in the primary outcome. Secondary outcomes included duration of the procedure, vital parameters, vasovagal symptoms, and participant satisfaction index (0-10 rating scale).
A total of 138 women (46 per group) participated in the study between January 2016 and April 2016. No differences were found between groups regarding age, weight, body mass index, parity status, menopausal status, or previous hysteroscopy status. Visual analog scale scores highlighted a decrease in pain in the active TENS group compared with the placebo group (entry: -11 mm, 95% confidence interval [CI] -17 to -5; contact: -21.9 mm, 95% CI -30 to -13.9; biopsy: -30.5 mm, 95% CI -47.1 to -13.8, P<.001). Moreover, the reduction in pain reached the minimum clinically relevant difference. Regarding satisfaction, results also revealed differences between active TENS and placebo groups (1.3, 95% CI 0.5-2.2, P=.001).
Transcutaneous electrical nerve stimulation reduces pain and increases patient satisfaction during office hysteroscopy without sedation.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT02647008.
评估无镇静门诊宫腔镜检查中经皮神经电刺激（TENS）的止痛效果。
我们进行了一项随机、双盲、安慰剂对照试验。参与者被随机分配到主动 TENS、安慰剂 TENS 或对照组。主动 TENS 干预包括使用两个自粘电极在 T10-L1 和 S2-S4 水平与脊髓平行放置，对高频（80-100 Hz）、400 微秒、个体调整的高强度 TENS 应用进行变化。在安慰剂组中，参与者连接到 TENS 装置，但不提供电刺激。主要结局是在几个阶段（进入、接触、活检和残留）使用视觉模拟量表（0-100mm）自我报告的疼痛强度。视觉模拟量表的最小临床相关差异先前已报道为 10mm。样本量的计算旨在提供 80%的功效，以显示主要结局的 10mm 差异（α=0.0125）。次要结局包括手术持续时间、生命体征、血管迷走神经症状和参与者满意度指数（0-10 评分量表）。
2016 年 1 月至 4 月期间，共有 138 名女性（每组 46 名）参与了这项研究。各组在年龄、体重、体重指数、产次、绝经状态或既往宫腔镜检查状态方面无差异。视觉模拟量表评分显示，与安慰剂组相比，主动 TENS 组的疼痛减轻（进入时-11mm，95%置信区间[CI] -17 至-5；接触时-21.9mm，95%CI -30 至-13.9；活检时-30.5mm，95%CI -47.1 至-13.8，P<.001）。此外，疼痛的减轻达到了最小的临床相关差异。关于满意度，结果也显示了主动 TENS 和安慰剂组之间的差异（1.3，95%CI 0.5-2.2，P=.001）。
在无镇静门诊宫腔镜检查中，经皮神经电刺激可减轻疼痛并提高患者满意度。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT02647008。
