Women's Health Research Laboratory (LAMU), Physical Therapy Department, Universidade Federal de São Carlos, São Carlos, SP, Brazil.
Laboratory of Research on Electrophysical Agents (LAREF), Physical Therapy Department, Universidade Federal de São Carlos, São Carlos, SP, Brazil.
PLoS One. 2021 May 20;16(5):e0250111. doi: 10.1371/journal.pone.0250111. eCollection 2021.
Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 μs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.
原发性痛经（PD）是一种常见的妇科疾病，其特征是在月经期间下腹部痉挛性疼痛，而无明显的病理改变。经皮神经电刺激（TENS）用于促进 PD 疼痛缓解，但仍需要了解这种干预措施的参数和成本效益。因此，本研究旨在披露一项评估 TENS 对 PD 女性疼痛强度的有效性和成本效益的研究。这是一项评估员盲法随机对照试验的方案，包括 174 名年龄大于 18 岁、经数字评分量表（NRS）评估痛经程度大于或等于 4 分的 PD 女性。参与者将随机分为三组（主动 TENS、假 TENS 和教育手册）。分配到主动 TENS 组的参与者将接受电刺激（F = 100 Hz，脉冲持续时间 = 200 μs，持续 30 分钟）。相比之下，假 TENS 组将接受假刺激（相同参数，但仅 30 秒，然后在 15 秒的时间内逐渐关闭电流），连续三个月在月经期间进行。分配到教育手册组的参与者将接受有关 PD 相关健康促进和教育措施的指导。盲法评估员将评估疼痛强度（NRS）、出勤（斯坦福出勤量表）、健康相关生活质量（简短形式 6 维度和 SF-36）和月经疼痛的健康成本。这是第一项提出健康经济学评价的同时评估 TENS 治疗 PD 症状的益处的研究。假设主动 TENS 在短期、中期和长期内比假 TENS 或教育手册更有效地改善临床结局。该研究还将提供关于 TENS 的成本效益信息，这可以为决策者在公共和私人卫生系统中改善 PD 护理提供参考。
