Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

Study Overview
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Brief Summary
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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
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The denouement will be the intensity of pain from visual analogue scale.

Official Title
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Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Device: TENS
* Device: TENS (sham)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS active<br>TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs) | Device: TENS<br>* 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.<br>* Other names: TENS - eletric pulse generator;|
| Sham Comparator: TENS sham<br>Placebo lasting 35 minutes. | Device: TENS (sham)<br>* In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | participants will be monitored for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of analgesia after application | check the duration of analgesia after application of interactive TENS (proposed method) | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, Dysmenorrhea, analgesia, interactive