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

Cancer, Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903276
• Other study ID #: 90466098200
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: August 2020
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer, Lung
• Lung Neoplasms

Intervention

Other:
• rehabilitation
Tens

Locations

Country	Name	City	State
Brazil	Universidade do Estado do Pará	Belém	Pará

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba	Universidade do Estado do Pará

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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 — View 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. Review. — View Citation

Rushton DN. Electrical stimulation in the treatment of pain. Disabil Rehabil. 2002 May 20;24(8):407-15. Review. — View 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). Ches — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	post treatment in 3 days
Primary	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	post treatment in 3 days