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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
taVNS
DeviceIntervention Name: Transauricular Vagus Nerve Stimulation (taVNS) Intervention Description: Participants will receive transauricular vagus nerve stimulation on the tragus. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless.
SHAM stimulation
DeviceIntervention Name: SHAM stimulation of the earlobe. Participants will receive SHAM stimulation on the earlobe, which does not stimulate the vagus nerve. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Placebo stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: taVNS - transauricular vagal nerve stimulationExperimental treatment 1 intervention
Group B: SHAM stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduction the use of rescue medications
Significative reduction in the number of cases of rescue medication after the treatment employing the taVNS in respect to the sham condition.
Time frame
During the first 3 days of menstrualSecondary outcomes
1
Reduction in acute and mean menstrual pain severity
Significative reduction in acute and mean (across the 3 days) menstrual pain severity assessed via Numeric Rating Scale (NRS) after the treatment employing the taVNS in respect to the sham condition.
Time frame
During the first 3 days of menstrual2
Reduction in menstrual pain severity at the Short form McGill Pain Questionnarie
Reduction in menstrual pain severity employing using the Short form McGill pain questionnaire during the experimental condition in comparison to the sham condition
Time frame
During the first 3 days of menstrual3
Changes in affective symptoms
Decrease of the score in at least one if the following scale: in Trait Anxiety Inventory (STAI), Beck's Depression Inventory II, Positive and Negative Affect Schedule (PANAS) and Pain Catastrophizing Scale (PCS).
Time frame
First day of stimulation, last day of stimulation.4
Changes in fMRI signal in the mesocorticolimbic system
Changes in fMRI signal in the areas of the mesocorticolimibic system during the execution of a reward fMRI task (Monetary incentive delay task, Kuntson et al., 2001).
Time frame
After the first month application of the taVNS and of the SHAM stimulationSponsors and contacts
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Source ClinicalTrials.gov