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Evaluation of the Effect of TMS on Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active rTMS
sham rTMS
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring rTMS, Primary Dysmenorrhea

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xi 'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active rTMS

sham rTMS

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2019
Last Updated
March 9, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04168489
Brief Title
Evaluation of the Effect of TMS on Primary Dysmenorrhea
Official Title
Based on Functional Magnetic Resonance Imaging Technology to Evaluate the Analgesic Effect of TMS on Primary Dysmenorrhea and Neuroimaging Prediction Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
rTMS, Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
(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).
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active rTMS
Arm Type
Active Comparator
Arm Title
sham rTMS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
active rTMS
Intervention Description
(rTMS) is received preliminary approval because of its noninvasive and safe analgesic effect.
Intervention Type
Device
Intervention Name(s)
sham rTMS
Intervention Description
The sham rTMS is inactive and similar to placebo effect.
Primary Outcome Measure Information:
Title
Evaluation of effect of rTMS for primary dysmenorrhea
Description
Assessments using Visual Analog Score for pain(Units on a Scale) in primary dysmenorrhea during menstrual phase to evaluate the effect of rTMS
Time Frame
From 1 month before treatment to 3 months after treatment for each volunteers(through study completion, an average of 2 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wanghuan Dun, M.D.
Phone
0086-18092706568
Email
wanghuandun@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
ke wang, M.D.
Phone
15529620760
Ext
15529620760
Email
1740923504@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wanghuan Dun, M.D.
Organizational Affiliation
The First Affiliated Hospital of Xi 'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wanghuan dun, M.D.
Phone
0086-18092706568
Email
wanghuandun@163.com

12. IPD Sharing Statement

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Evaluation of the Effect of TMS on Primary Dysmenorrhea

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