Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea

NCT ID: NCT03184740

Last Updated: 2017-09-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-08-31

Brief Summary

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Technological advances and non-invasive techniques to modulate brain function have been developed, including transcranial Direct Current Stimulation (tDCS). Basically, electrodes are placed on the brain regions to stimulate or inhibit it. Subsequently, a continuous electrical current (0.4-2 mA) is imposed, for a period of 3-20 minutes, to modify cortical excitability. Few are the research groups that work on the topic of primary dysmenorrhea and the use of tDCS as the focus of study. Preliminary studies associated the use of tDCS with pain reduction, but the outcomes of physical and behavioral function needs further investigation.

Detailed Description

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Conditions

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Transcranial Direct Current Stimulation Dysmenorrhea Primary Pain Mental Disorders Physical Fitness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active-tDCS

A constant current (anodic) of 2mA will be applied for 20 minutes over the Primary motor cortex (M1).

Group Type EXPERIMENTAL

Active Transcranial Direct Current Stimulation

Intervention Type DEVICE

For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over Primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.

Sham-tDCS

A constant current (sham) of 2mA will be applied on the Primary motor cortex, but the stimulator will be turned off after 30 seconds .

Group Type SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type DEVICE

For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator will be turned off after 30 seconds of stimulation.

Interventions

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Active Transcranial Direct Current Stimulation

For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over Primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.

Intervention Type DEVICE

Sham Transcranial Direct Current Stimulation

For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator will be turned off after 30 seconds of stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- to have primary dysmenorrhea symptoms for more than 6 months with a mean perception of at least 3 (on a scale of 0 to 10) on the visual analogue scale, to have a regular menstrual cycle from 28 to 32 days.

Exclusion Criteria

\- Participants will be excluded if they have history of genitourinary disease (infectious oncology or infection), neurogenic bladder dysfunction, to have alcohol or drug abuse in the last 6 months, to have severe depression (score greater than 30 on the Beck depression inventory), to have previously neurological disorders diagnosis and to be pregnant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role lead

Responsible Party

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Edson meneses da silva filho

Master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Rio Grande do Norte

Santa Cruz, Rio Grande do Norte, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1.530.846

Identifier Type: -

Identifier Source: org_study_id

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