Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Device: TENS; Device: TENS (sham)

Detailed Description

The denouement will be the intensity of pain from visual analogue scale.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Investigators: Principal Investigator: Fábio M. Camilo, teacher, Fundação de Educação e Cultura de Santa Fé do Sul

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: TENS; Dysmenorrhea; analgesia; interactive
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: UFSaoCarlos0001/14; 036/2010 (Other Identifier: CEP-FISA/FUNEC)