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Completed

NCT Number: NCT03184740

Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea

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.

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Key information

Conditions

Transcranial Direct Current Stimulation Dysmenorrhea Primary Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Fitness Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio Grande do Norte

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in pain

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

    Pain diary will be used to assess pain levels

  2. Changes in pain

    Time frame: 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

    Visual Analogue Scale will be used to measure pain levels

  3. Changes in anxiety levels

    Time frame: 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

    Hamilton anxiety rating scale will be used to measure anxiety levels

  4. Changes in affectivity

    Time frame: 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

    Positive And Negative Affect Scale will be used to measure affectivity

  5. Changes in local pain levels

    Time frame: 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

    Digital pressure algometry will be used to measure local pain levels

  6. Changes in hand strength

    Time frame: 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

    Hydraulic hand dynamometer will be used to measure hand strength

  7. Changes in functional capacity

    Time frame: 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

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

  8. Changes in flexibility

    Time frame: 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

    Thomas test will be used to measure flexibility

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea: A Randomized, Double Blind Clinical Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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