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

Primary Purpose

Cancer, Lung

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
rehabilitation
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Lung

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade do Estado do Pará

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

assessment of pain scale and functional capacity

assessment of pain scale and functional capacity, TENS 30 minutes 3 sessions

Outcomes

Primary Outcome Measures

Pain perception
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
Functional capacity
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

Secondary Outcome Measures

Full Information

First Posted
April 2, 2019
Last Updated
August 11, 2020
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará
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1. Study Identification

Unique Protocol Identification Number
NCT03903276
Brief Title
Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Lung Cancer
Official Title
Effects of Transcutaneous Electrical Nerve Stimulation in the Conventional Mode in Post-operative Lung Cancer Patients in a Reference Hospital in the Amazon Region
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
assessment of pain scale and functional capacity
Arm Title
Experimental
Arm Type
Experimental
Arm Description
assessment of pain scale and functional capacity, TENS 30 minutes 3 sessions
Intervention Type
Other
Intervention Name(s)
rehabilitation
Intervention Description
Tens
Primary Outcome Measure Information:
Title
Pain perception
Description
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
Time Frame
post treatment in 3 days
Title
Functional capacity
Description
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
Time Frame
post treatment in 3 days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadson Poça, graduated
Organizational Affiliation
Universidade do Estado do Pará
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade do Estado do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66055-490
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16360266
Citation
Ainsworth L, Budelier K, Clinesmith M, Fiedler A, Landstrom R, Leeper BJ, Moeller L, Mutch S, O'Dell K, Ross J, Radhakrishnan R, Sluka KA. Transcutaneous electrical nerve stimulation (TENS) reduces chronic hyperalgesia induced by muscle inflammation. Pain. 2006 Jan;120(1-2):182-187. doi: 10.1016/j.pain.2005.10.030. Epub 2005 Dec 19.
Results Reference
result
PubMed Identifier
17873166
Citation
Spiro SG, Gould MK, Colice GL; American College of Chest Physicians. Initial evaluation of the patient with lung cancer: symptoms, signs, laboratory tests, and paraneoplastic syndromes: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):149S-160S. doi: 10.1378/chest.07-1358.
Results Reference
result
PubMed Identifier
28261561
Citation
Hochberg U, Elgueta MF, Perez J. Interventional Analgesic Management of Lung Cancer Pain. Front Oncol. 2017 Feb 14;7:17. doi: 10.3389/fonc.2017.00017. eCollection 2017.
Results Reference
result
PubMed Identifier
12033995
Citation
Rushton DN. Electrical stimulation in the treatment of pain. Disabil Rehabil. 2002 May 20;24(8):407-15. doi: 10.1080/09638280110108832.
Results Reference
result

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

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