Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea

NCT03184740 | Completed

• 1 other identifier: 1.530.846
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transcranial Direct Current Stimulation; Dysmenorrhea Primary; Pain; Mental Disorders; Physical Fitness

Outcome Measures

Primary Outcomes (8)

• Changes in pain

  Pain diary will be used to assess pain levels

  It will be used throughout the first and second menstrual cycle (approximately 60 days).

• Changes in pain

  Visual Analogue Scale will be used to measure pain levels

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

• Changes in anxiety levels

  Hamilton anxiety rating scale will be used to measure anxiety levels

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

• Changes in affectivity

  Positive And Negative Affect Scale will be used to measure affectivity

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

• Changes in local pain levels

  Digital pressure algometry will be used to measure local pain levels

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

• Changes in hand strength

  Hydraulic hand dynamometer will be used to measure hand strength

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

• Changes in functional capacity

  Six-minute walk test will be used to measure functional capacity

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

• Changes in flexibility

  Thomas test will be used to measure flexibility

  First evaluation will be done between the first and third days of initial menstrual cycle. The second evaluation will be done between the first and third days of the next menstrual cycle

Study Arms (2)

Active-tDCS

EXPERIMENTAL

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

Device: Active Transcranial Direct Current Stimulation

Sham-tDCS

SHAM COMPARATOR

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

Device: Sham Transcranial Direct Current Stimulation

Interventions

Active Transcranial Direct Current Stimulation 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.

Active-tDCS

Sham Transcranial Direct Current Stimulation 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.

Sham-tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Federal University of Rio Grande do Norte

Santa Cruz, Rio Grande do Norte, 59200-000, Brazil

Location

MeSH Terms

Conditions

Pain; Mental Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: June 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

BR (1)