Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Dysmenorrhea Primary; Transcranial Direct Current Stimulation; Physical Fitness; Pain; Mental Disorders
• Interventions: Device: Active Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation

• Registration Number: NCT03184740
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-14
• Primary Completion: 2017-07-31
• Study Completion: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-09
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active-tDCS	Active Transcranial Direct Current Stimulation	A constant current (anodic) of 2mA will be applied for 20 minutes over the Primary motor cortex (M1).
Sham-tDCS	Sham Transcranial Direct Current Stimulation	A constant current (sham) of 2mA will be applied on the Primary motor cortex, but the stimulator will be turned off after 30 seconds .

Primary Outcome Measures

Name	Time	Method
Changes in pain	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
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 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 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 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 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 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

Trial Locations

Locations (1)

Federal University of Rio Grande do Norte; 🇧🇷 Santa cruz, Rio Grande do Norte, Brazil