Evaluation of the Effect of TMS on Primary Dysmenorrhea

Overview

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.

Full Title of Study: “Based on Functional Magnetic Resonance Imaging Technology to Evaluate the Analgesic Effect of TMS on Primary Dysmenorrhea and Neuroimaging Prediction Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 30, 2023

Detailed Description

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.

Interventions

  • Device: active rTMS
    • (rTMS) is received preliminary approval because of its noninvasive and safe analgesic effect.
  • Device: sham rTMS
    • The sham rTMS is inactive and similar to placebo effect.

Arms, Groups and Cohorts

  • Active Comparator: active rTMS
  • Sham Comparator: sham rTMS

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of effect of rTMS for primary dysmenorrhea
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • 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). Exclusion Criteria:

  • 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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital Xi’an Jiaotong University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • wanghuan Dun, M.D., Study Chair, The First Affiliated Hospital of Xi ‘an Jiaotong University
  • Overall Contact(s)
    • wanghuan Dun, M.D., 0086-18092706568, wanghuandun@163.com

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