Based on Functional Magnetic Resonance Imaging Technology to Evaluate the Analgesic Effect of TMS on Primary Dysmenorrhea and Neuroimaging Prediction Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of effect of rTMS for primary dysmenorrhea
研究概览
简要总结
Based on the pain threshold and visual simulation score, primary dysmenorrhea patients will be divided into treatment effective group or non-effective group.According to the functional magnetic resonance imaging, the investigators investigate whether there is characteristic or secondary brain features before and after rTMS intervention.
详细描述
Long term primary dysmenorrhea may induce a series of disorders involving psychology, lower quality of life, or even developing chronic organic lesion or chronic pain. Effective symptom improvement is urgently needed. During the Non-pharmaceutical interventions, repetitive transcranial magnetic stimulation (rTMS) is received preliminary approval because of its noninvasive and safe analgesic effect. In this randomized single blind longitudinal study, the investigators investigate the analgesic effect of rTMS in long term moderate-to-severe primary dysmenorrhea women. Based on the pain threshold and visual simulation score, primary dysmenorrhea patients will be divided into treatment effective group or non-effective group. According to the functional magnetic resonance imaging, the investigators investigate whether there is characteristic or secondary brain features before and after rTMS intervention. By combining pre and post performances of the degree of dysmenorrhea, behavioral data and sensitive hematological indicators, the investigators intend to build an association model between brain and pain development curve. Using correlation and multiple regression analysis method, the investigators intend to find sensitive neuroimaging biomarkers in predicting the analgesic effect of rTMS. The current study is not only contributing to improve the central nervous systematic mechanism of rTMS in chronic pelvic pain, but also significant for clinical effective treatment based on neuroimaging predictive markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •consistent with the diagnostic criteria for primary dysmenorrhea according to the American College of Obstetricians and Gynecologists;
- •regular menstrual cycles (27-32 days);
- •the average intensity of dysmenorrhoeic pain in the past 6 months should be rated ≥4 on a visual analogue scale (VAS) (0 = no pain, 10 = the worst imaginable pain).
排除标准
- •organic pelvic disease;
- •using oral contraceptives, hormonal supplements, Chinese traditional medicine or any central-acting medication (e.g., opioids, anti-epileptics) within 6 months before the study;
- •comorbid chronic pain states;
- •alcohol, nicotine or drug addiction;
- •neurologic disease or psychiatric disorder;
- •history of childbirth;
- •a positive pregnancy test or immediate plans for pregnancy;
- •any MRI contraindications. In addition, no analgesics were consumed 24 hours prior to the experiment.
结局指标
主要结局
Evaluation of effect of rTMS for primary dysmenorrhea
时间窗: From 1 month before treatment to 3 months after treatment for each volunteers(through study completion, an average of 2 years)
Assessments using Visual Analog Score for pain(Units on a Scale) in primary dysmenorrhea during menstrual phase to evaluate the effect of rTMS
次要结局
未报告次要终点