NCT01897311

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
Last Updated

April 21, 2017

Status Verified

July 1, 2013

Enrollment Period

9 months

First QC Date

May 24, 2013

Last Update Submit

April 20, 2017

Conditions

Pain

Keywords

cesarean sectionpaintranscutaneous electrical nerve stimulationpostpartum period

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain after cesarean

    after TENS application

Study Arms (3)

grupo TENS com frequência de 100 Hz

EXPERIMENTAL

TENS application of high frequency (100 Hz, 100 μs)

Device: transcutaneous electrical nerve stimulation

grupo TENS com frequência de 4 Hz

EXPERIMENTAL

Application of low-frequency TENS (4 Hz, 100 μs)

Device: transcutaneous electrical nerve stimulation

Placebo with TENS off

PLACEBO COMPARATOR

TENS application when off

Device: transcutaneous electrical nerve stimulation

Interventions

transcutaneous electrical nerve stimulationDEVICE
Placebo with TENS offgrupo TENS com frequência de 100 Hzgrupo TENS com frequência de 4 Hz

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa de Misericordia Hospital and State Hospital Dirceu Arco Verde

Parnaíba, Piauí, 64204-100, Brazil

Location

Related Publications (1)

  • Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

    PMID: 32871021DERIVED

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Janaina Mayer de Oliveira Nunes

    University Federal Piauí

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent teacher

Study Record Dates

First Submitted

May 24, 2013

First Posted

July 11, 2013

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

April 21, 2017

Record last verified: 2013-07

Locations

BR(1)