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

November 8, 2022 updated by: Daniel David Álamo Arce, University of Las Palmas de Gran Canaria

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35008
        • University Hospital of Gran Canaria Dr. Negrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
1. Control group. Patients have performed the conventional postsurgical program without adding TENS.
Device: Control
Post-surgical physiotherapeutic activity.
Experimental: Experimental Group
Experimental group. The application of TENS has been added to the physiotherapy program. It had a frequency of 100 Hz and a phase duration of 100 µsec for a period of 30 minutes (through channel 1 of the TENS equipment), receiving and feeling the patient the physical sensation of the current.
Device: Experimental
Post-surgical physiotherapeutic activity with the application of the technique
Placebo Comparator: Placebo Group
Placebo group. In this group, the same program as group 2 was proposed, using, in this case, channel 2, which did not activate the electric current, and the patient did not receive any physical sensation
Device: Placebo
Post-surgical physiotherapeutic activity with the application of the non-activated technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: Six month
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
McGill Test
Time Frame: Six month
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
Quality of life survey sf-36
Time Frame: Six month
The SF-36 Questionnaire is one of the most used and evaluated Health-Related Quality of Life (HRQOL) instruments.
Six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Las Palmas de Gran Canaria

Investigators

  • Principal Investigator: Daniel David Álamo Arce, P.T., Teaching professor and researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 15012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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