Effect of Modulation of TENS in Pain After Cesarean Section

April 20, 2017 updated by: Janaina Mayer de Oliveira Nunes, Universidade Federal do Piauí

Hypoalgesic Effect of TENS Modulation in Post-Cesarean Pain: A Clinical Trial Controlled and Randomized.

The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mothers were randomly divided into three groups (G100, G4 and placebo (GP) - appliance off) and evaluated by NRS (numeric rating scale) before, immediately after application of TENS, and every 20 minutes until he was one hour after the application of electroanalgesia, to verify its effectiveness over time.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Piauí
      • Parnaíba, Piauí, Brazil, 64204-100
        • Santa Casa de Misericordia Hospital and State Hospital Dirceu Arco Verde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • aged 18 years
  • present pain at the site of surgical incision less than three according to Category Numerical Scale (NRS)
  • literate oriented as to time and space
  • with spinal anesthesia before surgery
  • incision pfannenstiel type with absence of genitourinary pathology
  • primiparous or multiparous

Exclusion Criteria:

  • patients with abnormal sensitivity to clinical examination
  • demyelinating diseases
  • spinal cord injury
  • hemorrhage
  • infection
  • fever
  • anesthetic complications
  • hypertension, mammary, intolerance, irritation or strong discomfort at the injection site caused by TENS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: grupo TENS com frequência de 100 Hz
TENS application of high frequency (100 Hz, 100 μs)
Device: transcutaneous electrical nerve stimulation
Experimental: grupo TENS com frequência de 4 Hz
Application of low-frequency TENS (4 Hz, 100 μs)
Device: transcutaneous electrical nerve stimulation
Placebo Comparator: Placebo with TENS off
TENS application when off
Device: transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of pain after cesarean
Time Frame: after TENS application
after TENS application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Piauí

Investigators

  • Principal Investigator: Janaina Mayer de Oliveira Nunes, University Federal Piauí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0295.0.045.000-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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