Evaluation of the Effect of TMS on Primary Dysmenorrhea

NCT04168489 | Unknown

• 1 other identifier: Grant Nos. 81901723
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

rTMS; Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Evaluation of effect of rTMS for primary dysmenorrhea

  Assessments using Visual Analog Score for pain(Units on a Scale) in primary dysmenorrhea during menstrual phase to evaluate the effect of rTMS

  From 1 month before treatment to 3 months after treatment for each volunteers(through study completion, an average of 2 years)

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

Device: active rTMS

sham rTMS

SHAM COMPARATOR

Device: sham rTMS

Interventions

active rTMS DEVICE

(rTMS) is received preliminary approval because of its noninvasive and safe analgesic effect.

active rTMS

sham rTMS DEVICE

The sham rTMS is inactive and similar to placebo effect.

sham rTMS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Study Officials

• wanghuan Dun, M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

wanghuan Dun, M.D.

CONTACT

0086-18092706568; wanghuandun@163.com

ke wang, M.D.

CONTACT

15529620760; 1740923504@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: (a) consistent with the diagnostic criteria for primary dysmenorrhea according to the American College of Obstetricians and Gynecologists; (b) regular menstrual cycles (27-32 days); and (c) 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).

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 19, 2019
• Study Start: July 20, 2022
• Primary Completion: December 30, 2023
• Study Completion: July 30, 2024
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

CN (1)