Evaluation of the Effect of TMS on Primary Dysmenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-20

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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active rTMS

Group Type ACTIVE_COMPARATOR

active rTMS

Intervention Type DEVICE

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

sham rTMS

Group Type SHAM_COMPARATOR

sham rTMS

Intervention Type DEVICE

The sham rTMS is inactive and similar to placebo effect.

Interventions

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active rTMS

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

Intervention Type DEVICE

sham rTMS

The sham rTMS is inactive and similar to placebo effect.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes