Pain Relief From Dysmenorrhea Employing taVNS

ConditionDysmenorrhea Primary

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorUniversity of Electronic Science and Technology of China

About this trial

The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is:

• Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation? Researchers will compare taVNS stimulation with a sham stimulation (a look-alike procedure that does not stimulate the vagus nerve) to assess whether taVNS is effective in treating moderate dysmenorrhea.

Participants will:

* Undergo taVNS for 2 months and sham stimulation for another 2 months, each for 5 days per month, starting 2 days before the expected beginning of their menstrual cycle. * Visit the clinic twice a month for checkups and tests. * Keep a diary to record their pain levels and the number of times they use rescue medication. * Undergo functional magnetic resonance imagine two times (one after the end of the first use of taVNS and another after the end of the first use of SHAM stimulation).

Eligibility criteria

Qualifiers

Regular menstrual cycle (28 days ± 7 days);

Average moderate menstrual pain (with 4 - 7 NRS scores);

History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days);

4 consecutive monthly menstrual cycles;

Disqualifiers

Currently under medications (except for analgesic medication for menstrual cycle);

Use of oral contraceptive;

Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection);

Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder, hypertension, any bleeding disorders, recent surgery, or concurrent blood thinning treatment);

Trial design

Treatments tested in this trial

taVNS
SHAM stimulation

Treatment groups

20 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Electronic Science and Technology of China

Lead sponsor

Source ClinicalTrials.gov