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

NCT03903276 | Completed DMC

• 1 other identifier: 90466098200
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Lung

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Control

NO INTERVENTION

assessment of pain scale and functional capacity

Experimental

EXPERIMENTAL

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

Other: rehabilitation

Interventions

rehabilitation OTHER

Tens

Experimental

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Universidade do Estado do Pará: collaborator

Study Sites (1)

Universidade do Estado do Pará

Belém, Pará, 66055-490, Brazil

Location

Related 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. 2006 Jan;120(1-2):182-187. doi: 10.1016/j.pain.2005.10.030. Epub 2005 Dec 19.

  PMID: 16360266 RESULT

• 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.

  PMID: 17873166 RESULT

• 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.

  PMID: 28261561 RESULT

• Rushton DN. Electrical stimulation in the treatment of pain. Disabil Rehabil. 2002 May 20;24(8):407-15. doi: 10.1080/09638280110108832.

  PMID: 12033995 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jadson Poça, graduated

  Universidade do Estado do Pará

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Human Movement Department

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: August 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)