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

Primary Purpose

Thoracic, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control
Experimental
Placebo
Sponsored by
University of Las Palmas de Gran Canaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic focused on measuring Rehabilitation, Transcutaneous Electric Nerve Stimulation, Thoracic surgery, Postoperative pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Gran Canaria Dr. Negrín

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Control Group

Experimental Group

Placebo Group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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
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).
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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2021
Last Updated
November 8, 2022
Sponsor
University of Las Palmas de Gran Canaria
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1. Study Identification

Unique Protocol Identification Number
NCT04964973
Brief Title
Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery.
Official Title
Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery: Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Las Palmas de Gran Canaria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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?
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: Physical functioning. Limitation due to physical problems. Body pain. Functioning or social role. Mental health. Limitation due to emotional problems. Vitality, energy or fatigue. 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: 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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic, Postoperative Pain
Keywords
Rehabilitation, Transcutaneous Electric Nerve Stimulation, Thoracic surgery, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
1. Control group. Patients have performed the conventional postsurgical program without adding TENS.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Post-surgical physiotherapeutic activity.
Intervention Type
Device
Intervention Name(s)
Experimental
Intervention Description
Post-surgical physiotherapeutic activity with the application of the technique
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Post-surgical physiotherapeutic activity with the application of the non-activated technique
Primary Outcome Measure Information:
Title
Spirometry
Description
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
Time Frame
Six month
Title
McGill Test
Description
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).
Time Frame
Six month
Title
Quality of life survey sf-36
Description
The SF-36 Questionnaire is one of the most used and evaluated Health-Related Quality of Life (HRQOL) instruments.
Time Frame
Six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel David Álamo Arce, P.T.
Organizational Affiliation
Teaching professor and researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Gran Canaria Dr. Negrín
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21084984
Citation
Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.
Results Reference
background
PubMed Identifier
32036406
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.
Results Reference
background
PubMed Identifier
22219414
Citation
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.
Results Reference
background
PubMed Identifier
5320816
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.
Results Reference
background
PubMed Identifier
17410506
Citation
Solak O, Turna A, Pekcolaklar A, Metin M, Sayar A, Solak O, Gurses A. Transcutaneous electric nerve stimulation for the treatment of postthoracotomy pain: a randomized prospective study. Thorac Cardiovasc Surg. 2007 Apr;55(3):182-5. doi: 10.1055/s-2006-924631.
Results Reference
background

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

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