Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Lung Cancer

August 11, 2020 updated by: Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Effects of Transcutaneous Electrical Nerve Stimulation in the Conventional Mode in Post-operative Lung Cancer Patients in a Reference Hospital in the Amazon Region

Among all cancers, lung cancer is the most common disease on the planet, accounting for 13% of the cases, and leading the number of deaths from malignant diseases. In Brazil, it is estimated that its incidence between 2018 and 2019 could be 18,704 new cases in men and 12,503,000 new cases in women. These data take into account an estimated risk of 18.16 new cases for 100,000 men and 11.81 for 100,000 women, respectively occupying the second and fourth most frequent cases of the disease according to gender .

Surgeries, however aggressive they may be, are one of the most viable alternatives for patients with PC, provided it is performed in the milder or early phase of the disease, since after such period this procedure may have a period degree greater than the other forms of treatment.

As a consequence, the injuries that the surgical procedure can cause to patients, pain is one of the most influential in the patient's quality of life. It can lead the individual to a marked state of disability both functional and psychological, thus being determinant for the suffering related to the disease, thus comprising its multifactorial character, involving physical, emotional, socio-cultural and environmental aspects .

For the control of pain, physiotherapy appears with features such as transcutaneous nerve electrostimulation, where its use for the suppression of pain has become quite feasible due mainly to the ease of its handling, to be noninvasive and to serve to reduce acute pain and chronic.

The use of conventional transcutaneous nerve electrostimulation to support the use of analgesics reduced the intensity of pain in patients of the second day of thoracotomy, but for a longer extension of their effects, it would take a longer time to apply the resource, something around 24 -48 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

    • Pará
      • Belém, Pará, Brazil, 66055-490
        • Universidade do Estado do Pará

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with Primary Lung Cancer; male over 18 years and less than 59 years old, in an immediate postoperative period in the ward of the Hospital thoracic clinic.
  • Evaluation of pain through the visual analogue scale equal to or greater than moderate or intense.
  • Percentage equal to or greater than 70% in all the items assessed by the Performance Status functional capacity scale.

Exclusion Criteria:

  • Patients with immediate postoperative complications
  • Unconscious or sedation patients
  • Patients with invasive mechanical ventilation
  • Patients who present lesions that make it difficult to handle and place electrodes.
  • Patients who use pacemakers and metal plates.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
assessment of pain scale and functional capacity
Experimental: Experimental
assessment of pain scale and functional capacity, TENS 30 minutes 3 sessions
Tens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception
Time Frame: post treatment in 3 days
Visual analogue scale - EVA: consists of checking the intensity of pain in patients at the moment it is being evaluated. Such a tool consists of a line with the ends numbered from 0 to 10, and from 0 to 2 it is considered light pain; 3 to 7 moderate pain; and 8 to 10 severe pain
post treatment in 3 days
Functional capacity
Time Frame: post treatment in 3 days
Functional capacity scale Performance Status- PS: aims to monitor the clinical evolution of a disease by joining the Karnofsky scale and the Zubrod or ECOG scale. Karnofsky's scale or index describes increasing levels of activities and independence of the individual stipulated values between 0 and 100, zero meaning no functionality or death and 100 representing the maximum degree of physical ability to perform activities. The Zubrod or ECOG scale quantified between 0 and 4, where 0 means 0 indicates that the individual is fully active for the performance of his activities and 4 assigning to the dead patient. Such scales are widely used for the evaluation of oncological patients, being somewhat complementary, therefore used together
post treatment in 3 days

Collaborators and Investigators

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

Investigators

  • Study Chair: Jadson Poça, graduated, Universidade do Estado do Pará

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.

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 (Actual)

August 1, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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