Pain relief for menstrual cramps using taVNS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Uestc
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Stefania Ferraro, PhD
• Email: stefania@uestc.edu.cn
• Phone: +86 18684009672

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Over-the-counter pain medicine comparison for period cramps in women with Crohn's disease

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• Effects of kinesiology taping and relaxation techniques on menstrual pain

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• Myofascial release technique for menstrual pain relief in women

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  Recruiting Gazi University · Ankara · NCT06492148

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.