Actively Recruiting
A Randomized Two-Way Crossover Study Comparing Pain Relief From Dysmenorrhea Using Transauricular Vagus Nerve Stimulation and Sham Stimulation
Led by University of Electronic Science and Technology of China · Updated on 2025-04-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Pain Relief From Dysmenorrhea Employing taVNS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 45 years
- Regular menstrual cycle (28 days ± 7 days)
- Moderate menstrual pain with a Numeric Rating Scale score between 4 and 7
- History of using over-the-counter analgesics for menstrual pain (at least 1 ibuprofen dose in the first two days)
- Experiencing 4 consecutive monthly menstrual cycles
- Not pregnant
- Agree to use adequate birth control during the trial
- Generally healthy
- Agree not to participate in other clinical trials during this study
- No facial or ear pain, no recent ear trauma, no metal implants including pacemakers
- Normal ECG, heart rate, and blood pressure within specified ranges
You will not qualify if you...
- Currently taking medications other than analgesics for menstrual pain
- Use of oral contraceptives
- Secondary causes of dysmenorrhea such as endometriosis, adenomyosis, uterine fibroids, or infection
- Unstable or serious illnesses including kidney, liver, gastrointestinal, heart, thyroid, lung conditions, chronic asthma, psychological or mood disorders, hypertension, bleeding disorders, recent surgery, or blood thinning treatment
- Current or recent malignancy treatment within 2 years
- Pregnant or breastfeeding women
- Active smokers, nicotine users, or drug abuse
- Chronic alcohol use exceeding 14 drinks per week
- Any condition making participation unsuitable as judged by the investigator
- Unwilling or unable to comply with study protocol
- Active genitourinary infection in the past 4 weeks
- Unable to read or understand informed consent
- Unwilling to complete study procedures
- Participation in another clinical trial within the past month
- Personal or family history of seizure, mood, or cardiovascular disorders
- Allergic reaction to surface electrodes
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months per stimulation type
Participants receive two different types of stimulation in a randomized crossover design: transauricular vagus nerve stimulation (taVNS) and sham stimulation. Each type of stimulation is applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months per stimulation. Each day includes two 15-minute sessions, one at 10 AM and one at 6 PM. Participants adjust the stimulation to a painless level.
2 sessions per day for 5 days each month, repeated for 2 months per stimulation type
Trial Site Locations
Total: 1 location
1
UESTC
Chengdu, Sichuan, China, 611731
Actively Recruiting
Research Team
S
Stefania Ferraro, PhD
J
Jaili He
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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