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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-03-08

Brief Summary

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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?

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Detailed Description

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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).

Conditions

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Thoracic Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The principal investigator and the patient do not know which technique will be applied. The principal investigator and the patients do not know which group they are in, intervention, placebo or control.

Study Groups

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Control Group

1\. Control group. Patients have performed the conventional postsurgical program without adding TENS.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

Post-surgical physiotherapeutic activity.

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.

Group Type EXPERIMENTAL

Experimental

Intervention Type DEVICE

Post-surgical physiotherapeutic activity with the application of the technique

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Post-surgical physiotherapeutic activity with the application of the non-activated technique

Interventions

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Control

Post-surgical physiotherapeutic activity.

Intervention Type DEVICE

Experimental

Post-surgical physiotherapeutic activity with the application of the technique

Intervention Type DEVICE

Placebo

Post-surgical physiotherapeutic activity with the application of the non-activated technique

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No