Study Comparing Pain Relief From Dysmenorrhea Using Ear Nerve Stimulation and Sham Treatment in Women Aged 18 to 45

What this Trial Is About

Researchers are evaluating the effectiveness of transauricular vagal nerve stimulation taVNS in treating moderate dysmenorrhea, a condition causing menstrual pain. The study aims to find out if taVNS can reduce the use of rescue medications during menstruation. Participants will receive two types of stimulation active taVNS and a sham placebo stimulation that mimics the procedure but does not stimulate the nerve. This study uses a randomized, crossover design and is sponsored by the University of Electronic Science and Technology of China. Participants will undergo taVNS applied to the tragus of the ear and sham stimulation applied to the earlobe. Each treatment consists of two daily 15-minute sessions for 5 days each menstrual cycle, starting 2 days before menstruation, over two months for each intervention. The level of stimulation can be adjusted by participants to a comfortable, painless level. The trial includes two treatment periods with taVNS and sham stimulation, separated by a crossover. Participants will visit the clinic twice monthly for checkups and tests while keeping a diary to record pain levels and medication use. Functional magnetic resonance imaging fMRI will be performed twice to observe brain activity changes after each stimulation period. Researchers will measure reductions in rescue medication use and pain severity during the first three days of menstruation, along with affective symptoms and brain signaling changes. The total study duration spans four months of treatment with ongoing monitoring and assessments.

Pain Relief From Dysmenorrhea Employing taVNS