A Randomized Two-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Employing taVNS and Sham Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction the use of rescue medications
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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.
研究组 & 干预措施
taVNS - transauricular vagal nerve stimulation
Transauricular Vagus Nerve Stimulation (taVNS) will be applied in the tragus with the following parameters:
Pulse width: 500 microseconds; Frequency: 25 Hz; Stimulation cycle: 30 seconds on, 30 seconds off; Duration: 15 minutes per session; Current: Adjustable between 0 and 10 mA, with step increments of 0.1 mA.
干预措施: taVNS (Device)
SHAM stimulation
Stimulation of the earlobe will be applied with the following parameters:
Pulse width: 500 microseconds; Frequency: 25 Hz; Stimulation cycle: 30 seconds on, 30 seconds off; Duration: 15 minutes per session; Current: Adjustable between 0 and 10 mA, with step increments of 0.1 mA.
干预措施: SHAM stimulation (Device)
结局指标
主要结局
Reduction the use of rescue medications
时间窗: During the first 3 days of menstrual
Significative reduction in the number of cases of rescue medication after the treatment employing the taVNS in respect to the sham condition.
次要结局
- Changes in affective symptoms(First day of stimulation, last day of stimulation.)
- Changes in fMRI signal in the mesocorticolimbic system(After the first month application of the taVNS and of the SHAM stimulation)
- Reduction in acute and mean menstrual pain severity(During the first 3 days of menstrual)
- Reduction in menstrual pain severity at the Short form McGill Pain Questionnarie(During the first 3 days of menstrual)
研究者
stefania
Prof. Stefania Ferraro
University of Electronic Science and Technology of China