Clinical trial NCT03903276: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Lung
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
Collaborators: name: Universidade do Estado do Pará
First posted: 2019-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain perception
timeFrame: post treatment in 3 days
measure: Functional capacity
timeFrame: post treatment in 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade do Estado do Pará
state: Pará
Study officials:
affiliation: Universidade do Estado do Pará
name: Jadson Poça, graduated
role: STUDY_CHAIR
References:
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.
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.
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.
citation: Rushton DN. Electrical stimulation in the treatment of pain. Disabil Rehabil. 2002 May 20;24(8):407-15. doi: 10.1080/09638280110108832.