Pain relief for menstrual cramps using taVNS

A Randomized Two-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Employing taVNS and Sham Stimulation

This study is testing if a new treatment called taVNS can help women with moderate menstrual cramps feel less pain and rely less on medication during their periods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Electronic Science and Technology of China (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06912386 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of transauricular vagal nerve stimulation (taVNS) in alleviating moderate dysmenorrhea. Participants will undergo taVNS for two months and a sham stimulation for another two months, with treatments starting two days before their menstrual cycle. They will keep a diary to track pain levels and medication use, and will attend clinic visits for assessments. The study aims to determine if taVNS can reduce the need for rescue medication during menstruation.

Who should consider this trial

Good fit: Ideal candidates are women with regular menstrual cycles experiencing moderate dysmenorrhea who have used over-the-counter pain relief.

Not a fit: Patients with secondary dysmenorrhea or those on oral contraceptives may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-pharmacological option for managing menstrual pain.

How similar studies have performed: While the use of taVNS is a novel approach for dysmenorrhea, similar techniques have shown promise in other pain management studies.

Eligibility criteria

Inclusion Criteria:

* 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;
* Non-pregnant status;
* Agrees to use adequate birth control during the trial;
* Otherwise, healthy;
* Agree not to participate in any other clinical trial while enrolled in this trial ;
* No facial or ear pain, no recent ear trauma, no metal implants including pacemakers;
* Normal ECG, Heart Rate and Blood Pressure (systolic BP 105-130, diastolic BP 60-90, heart rate per min at rest 60-85);

Exclusion Criteria:

* 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);
* Current malignancy or treatment for malignancy within the previous 2 years;
* Pregnant or lactating women;
* Active smokers, nicotine use, or drug (prescription or illegal substances) abuse;
* Chronic past and/or current alcohol use (\>14 alcoholic drinks per week);
* Any condition that in the opinion of the investigator, makes the participant unsuitable for inclusion;
* Unwilling or unable to comply with protocol;
* Active genitourinary infection in the last four weeks;
* Unable to read or comprehend the informed consent;
* Unwilling to complete study procedures;
* Participated in any other clinical trial during the past 1 month;
* Personal or family history of seizure, mood, or cardiovascular disorders;
* Allergic reaction to surface electrodes.

Where this trial is running

Chengdu, Sichuan

• Uestc — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Stefania Ferraro, PhD

Conditions Dysmenorrhea Primary; Dysmenorrhea; transauricular vagal nerve stimulation; Pain