Transcutaneous tibial nerve stimulation for quality-of-life improvement and sleep deficiency in women with primary dysmenorrhea: A randomized clinical trial

Abstract

Background: Primary dysmenorrhea is a leading cause of chronic cyclic pelvic pain, contributing to a reduced quality of life and sleep disturbances in women. The objective of this study was to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in improving the quality of life, sleep, and overall health perceptions of participants compared to a control group of women with dysmenorrhea over short-term, medium-term, and long-term periods. Methods: A single-blind, controlled clinical trial was conducted, with participants randomly assigned to an experimental group (receiving TTNS) or a control group (receiving sham TTNS). Both groups underwent 12, weekly 30 min sessions using the NeuroTrac™ PelviTone electrostimulation device. Outcomes related to quality of life, sleep deficiency, and overall improvement were evaluated at three time points: short-term (post-treatment), medium-term (1–3 months), and long-term (6 months). Results: Of the 61 participants initially randomized (31 in the experimental group and 30 in the control group), 55 completed the study and were included in the final analysis. A statistically significant improvement was observed in the experimental group in both physical and mental health components, as measured by the SF-36v2® questionnaire, following 12 weeks of intervention, compared to the control group, persisting 6 months after the intervention. Additionally, statistically significant differences in overall improvement were noted between the two groups, as measured by the PGIC questionnaire at the end of treatment (p = 0.0103) and 6 months post-treatment (p = 0.0432). Conclusions: TTNS appears to be a safe and effective strategy for enhancing quality of life and overall health in women with PD, potentially reducing the reliance on pharmacological treatments or more invasive methods.