Back to resultsApplication of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS
TENS (sham)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring TENS, Dysmenorrhea, analgesia, interactive
Eligibility Criteria
Inclusion Criteria:
- Primary dysmenorrhoea
- Moderate to severe pain
Exclusion Criteria:
- Secondary dysmenorrhea
- Users of intrauterine device
- Cognitive impairment
- Failure to appear for treatment
- Pacemaker use
- Illicit drug use
- Epilepsy
- Skin problems
- Use of pain medication before the application of TENS
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
TENS active
TENS sham
Arm Description
TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)
Placebo lasting 35 minutes.
Outcomes
Primary Outcome Measures
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.
Secondary Outcome Measures
duration of analgesia after application
check the duration of analgesia after application of interactive TENS (proposed method)
Full Information
NCT ID
NCT02205970
First Posted
July 28, 2014
Last Updated
October 19, 2017
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02205970
Brief Title
Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.
Official Title
Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.
Detailed Description
The denouement will be the intensity of pain from visual analogue scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
TENS, Dysmenorrhea, analgesia, interactive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
one arm study
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS active
Arm Type
Active Comparator
Arm Description
TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)
Arm Title
TENS sham
Arm Type
Sham Comparator
Arm Description
Placebo lasting 35 minutes.
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
TENS - eletric pulse generator
Intervention Description
In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.
Intervention Type
Device
Intervention Name(s)
TENS (sham)
Intervention Description
In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.
Primary Outcome Measure Information:
Title
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
Description
To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.
Time Frame
participants will be monitored for 24 hours
Secondary Outcome Measure Information:
Title
duration of analgesia after application
Description
check the duration of analgesia after application of interactive TENS (proposed method)
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary dysmenorrhoea
Moderate to severe pain
Exclusion Criteria:
Secondary dysmenorrhea
Users of intrauterine device
Cognitive impairment
Failure to appear for treatment
Pacemaker use
Illicit drug use
Epilepsy
Skin problems
Use of pain medication before the application of TENS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio M. Camilo, teacher
Organizational Affiliation
Fundação de Educação e Cultura de Santa Fé do Sul
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.
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