Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184740
• Other study ID #: 1.530.846
• Status: Completed
• Phase: N/A
• First received: June 7, 2017
• Last updated: September 9, 2017
• Start date: June 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Dysmenorrhea Primary
• Mental Disorders
• Pain
• Physical Fitness
• Psychotic Disorders
• Transcranial Direct Current Stimulation

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Norte	Santa cruz	Rio Grande do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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