Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Device: TENS; Device: TENS (sham)

• Registration Number: NCT02205970
• Lead Sponsor: Universidade Federal de Sao Carlos

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS active	TENS	TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)
TENS sham	TENS (sham)	Placebo lasting 35 minutes.

Primary Outcome Measures

Name	Time	Method
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application	participants will be monitored for 24 hours	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

Name	Time	Method
duration of analgesia after application	1 week	check the duration of analgesia after application of interactive TENS (proposed method)