Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery.

Postoperative Pain Clinical Trial

Official title:

Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery: Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964973
• Other study ID #: CEIC 15012
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: March 8, 2022

Study information

• Verified date: November 2022
• Source: University of Las Palmas de Gran Canaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chest pain is one of the most difficult problems to solve after thoracic surgery. Its correct control is often quite difficult, which can cause complications due to an ineffective cough and superficial respiratory movements. It could provoke secretion retention, lung atelectasis, and even pneumonia. In addition, insufficient treatment of postoperative pain also causes a slower recovery of mobility, delaying the incorporation to daily life activities.

Transcutaneous electrical stimulation (TENS) is a technique that attempts to establish pain control by applying electrical current through superficial electrodes Is transcutaneous electrical nerve stimulation effective for the pain rehabilitation approach after thoracic surgery? Are there spirometry changes related to pulmonary function after the application of transcutaneous electrical nerve stimulation in postoperative rehabilitation of thoracic surgical patients?

Description:

All patients likely to be part of the study will have an exhaustive medical history. Said clinical history will have, as a basis, the following aspects:

• Filiation data.

• Personal history.

• Type of intervention carried out.

• Incisions made.

• Chronology, location and characteristics of pain. Once intervened, the data corresponding to the surgical intervention performed will be collected. Once the period of 7 days after the intervention has passed and in the absence of complications and pleural drainage, the period of respiratory physiotherapy will begin.

Assessment of quality of life The SF-36 (Short Form Health Survey) health questionnaire will be carried out. This questionnaire is used in medical and mental health research and, in general, in health-related research. It offers an overview of the health status of the person, with the advantage that it is quick and easy to fill out, while also being easy to assess. In the same way, by allowing the numerical assessment of different aspects of the health of the person, it becomes an excellent tool for any research related to health. It contains 36 questions that address different aspects related to the daily life of the person who fills in the questionnaire. These questions are grouped and measured in 8 sections that are evaluated independently and give rise to 8 dimensions that the questionnaire measures.

The eight dimensions are:

1. Physical functioning.

2. Limitation due to physical problems.

3. Body pain.

4. Functioning or social role.

5. Mental health.

6. Limitation due to emotional problems.

7. Vitality, energy or fatigue.

8. General perception of health. In 1991, the project known as "International Quality of Life Assessment" (International Quality of Life Assessment Project, IQOLA) was started, which basically consists of adapting and testing the intercultural applicability of a generic instrument called the SF-Health Survey. (Short Form 36 Health Survey).

The Spanish version of the SF-36 is one of the most widely used generic instruments in the national territory, both in descriptive studies that measure the impact on HRQL in different patient populations and for the evaluation of therapeutic interventions.

Pain assessment

The necessary tools to make a correct pain assessment. In this sense, two ways of measuring it will be established:

1. Self-reports, where the visual analog scale (VAS) will be the basic measurement tool. The pain will be marked with a scale from 0 (absence of pain) to 10 (maximum possible pain).

2. The standardized tests, as an objective of the study, are also proposed to analyze sensitive, affective and behavioral aspects of pain in these patients, it is for this reason that the Mc Gill test will be the tool to take into account.

Assessment of respiratory function The different respiratory parameters will be measured by spirometry (Siebel spirometer): Forced Vital Capacity (FVC); Forced expiratory volume of the first second (FEV1); FEV1 / FVC (Tiffeneau Index).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 8, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed the informed consent.

• Affected by pulmonary or mediastinal pathology.

• Who have required thoracic surgery.

Exclusion Criteria:

• Patients with pacemakers.

• Diseases with chronic need for analgesic drug.

• History of drug addiction.

• Patients who do not require hospital readmission after surgery.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Thoracic

Intervention

Device:
• Control
Post-surgical physiotherapeutic activity.
• Experimental
Post-surgical physiotherapeutic activity with the application of the technique
• Placebo
Post-surgical physiotherapeutic activity with the application of the non-activated technique

Locations

Country	Name	City	State
Spain	University Hospital of Gran Canaria Dr. Negrín	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Fiorelli A, Morgillo F, Milione R, Pace MC, Passavanti MB, Laperuta P, Aurilio C, Santini M. Control of post-thoracotomy pain by transcutaneous electrical nerve stimulation: effect on serum cytokine levels, visual analogue scale, pulmonary function and medication. Eur J Cardiothorac Surg. 2012 Apr;41(4):861-8; discussion 868. doi: 10.1093/ejcts/ezr108. Epub 2011 Dec 16. — View Citation

Husch HH, Watte G, Zanon M, Pacini GS, Birriel D, Carvalho PL, Kessler A, Sbruzzi G. Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pulmonary Function, and Respiratory Muscle Strength After Posterolateral Thoracotomy: A Randomized Controlled Trial. Lung. 2020 Apr;198(2):345-353. doi: 10.1007/s00408-020-00335-4. Epub 2020 Feb 8. — View Citation

Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available. — View Citation

Solak O, Turna A, Pekcolaklar A, Metin M, Sayar A, Solak O, Gürses A. Transcutaneous electric nerve stimulation for the treatment of postthoracotomy pain: a randomized prospective study. Thorac Cardiovasc Surg. 2007 Apr;55(3):182-5. — View Citation

Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry	It will consist of a simple spirometry using the Datospir Micro Sibelmed spirometer. The values of the forced vital capacity (FVC) and the volume expired forged in the first second (FEV1) are shown in percentages according to the theoretical values	Six month
Primary	McGill Test	A McGill test will be performed to analyze the level of immediate postoperative pain. The McGill test (Painting Classification Index) (PRI) measures three dimensions: sensory, affective, and evaluative. It consists of 66 words (pain descriptors).	Six month
Primary	Quality of life survey sf-36	The SF-36 Questionnaire is one of the most used and evaluated Health-Related Quality of Life (HRQOL) instruments.	Six month