Back to resultsPhysical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea
Primary Purpose
Transcranial Direct Current Stimulation, Dysmenorrhea Primary, Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Transcranial Direct Current Stimulation
Eligibility Criteria
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.
Sites / Locations
- Federal University of Rio Grande do Norte
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active-tDCS
Sham-tDCS
Arm Description
A constant current (anodic) of 2mA will be applied for 20 minutes over the Primary motor cortex (M1).
A constant current (sham) of 2mA will be applied on the Primary motor cortex, but the stimulator will be turned off after 30 seconds .
Outcomes
Primary Outcome Measures
Changes in pain
Pain diary will be used to assess pain levels
Changes in pain
Visual Analogue Scale will be used to measure pain levels
Changes in anxiety levels
Hamilton anxiety rating scale will be used to measure anxiety levels
Changes in affectivity
Positive And Negative Affect Scale will be used to measure affectivity
Changes in local pain levels
Digital pressure algometry will be used to measure local pain levels
Changes in hand strength
Hydraulic hand dynamometer will be used to measure hand strength
Changes in functional capacity
Six-minute walk test will be used to measure functional capacity
Changes in flexibility
Thomas test will be used to measure flexibility
Secondary Outcome Measures
Full Information
NCT ID
NCT03184740
First Posted
June 7, 2017
Last Updated
September 9, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT03184740
Brief Title
Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea
Official Title
Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea: A Randomized, Double Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Dysmenorrhea Primary, Pain, Mental Disorders, Physical Fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active-tDCS
Arm Type
Experimental
Arm Description
A constant current (anodic) of 2mA will be applied for 20 minutes over the Primary motor cortex (M1).
Arm Title
Sham-tDCS
Arm Type
Sham Comparator
Arm Description
A constant current (sham) of 2mA will be applied on the Primary motor cortex, but the stimulator will be turned off after 30 seconds .
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
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 Outcome Measure Information:
Title
Changes in pain
Description
Pain diary will be used to assess pain levels
Time Frame
It will be used throughout the first and second menstrual cycle (approximately 60 days).
Title
Changes in pain
Description
Visual Analogue Scale will be used to measure 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
Title
Changes in anxiety levels
Description
Hamilton anxiety rating scale will be used to measure 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
Title
Changes in affectivity
Description
Positive And Negative Affect Scale will be used to measure 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
Title
Changes in local pain levels
Description
Digital pressure algometry will be used to measure 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
Title
Changes in hand strength
Description
Hydraulic hand dynamometer will be used to measure 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
Title
Changes in functional capacity
Description
Six-minute walk test will be used to measure 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
Title
Changes in flexibility
Description
Thomas test will be used to measure 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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Santa cruz
State/Province
Rio Grande do Norte
ZIP/Postal Code
59200-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea
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