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Completed

NCT Number: NCT02205970

Application of Electrical Neurostimulation Transcutaneous 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.

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Key information

Conditions

Primary Dysmenorrhea Agnosia Dysmenorrhea Menstruation Disturbances Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Perceptual Disorders Signs and Symptoms

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

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

TENS (sham)

Device

In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.

Primary outcomes

  1. measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application

    Time frame: 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 outcomes

  1. duration of analgesia after application

    Time frame: 1 week

    check the duration of analgesia after application of interactive TENS (proposed method)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2014
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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