Dysmenorrhea Primary, Mental Disorders, Pain, Physical Fitness, Transcranial Direct Current Stimulation
Conditions
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.
Interventions
DEVICEActive 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.
DEVICESham 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.
Sponsors
Universidade Federal do Rio Grande do Norte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain | It will be used throughout the first and second menstrual cycle (approximately 60 days). | Pain diary will be used to assess pain levels |
| Changes in 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 | Hamilton anxiety rating scale will be used to measure anxiety levels |
| Changes in 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 | Positive And Negative Affect Scale will be used to measure affectivity |
| Changes in 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 | Digital pressure algometry will be used to measure local pain levels |
| Changes in 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 | Hydraulic hand dynamometer will be used to measure hand strength |
| Changes in 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 | Six-minute walk test will be used to measure functional capacity |
| Changes in 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 | Thomas test will be used to measure flexibility |
Countries
Brazil
Outcome results
None listed