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

NCT04964973 | Completed

• 1 other identifier: CEIC 15012
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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?

Conditions

Thoracic; Postoperative Pain

Keywords

Rehabilitation; Transcutaneous Electric Nerve Stimulation; Thoracic surgery; Postoperative pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Device: Control

Experimental Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Control DEVICE

Post-surgical physiotherapeutic activity.

Control Group

Experimental DEVICE

Post-surgical physiotherapeutic activity with the application of the technique

Experimental Group

Placebo DEVICE

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent.
• Affected by pulmonary or mediastinal pathology.
• Who have required thoracic surgery.

You may not qualify if:

• Patients with pacemakers.
• Diseases with chronic need for analgesic drug.
• History of drug addiction.
• Patients who do not require hospital readmission after surgery.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

University Hospital of Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, 35008, Spain

Location

Related Publications (6)

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

  PMID: 21084984 BACKGROUND

• 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.

  PMID: 32036406 BACKGROUND

• 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.

  PMID: 22219414 BACKGROUND

• 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.

  PMID: 5320816 BACKGROUND

• 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.

  PMID: 17410506 BACKGROUND

• Alamo-Arce DD, Lopez-Fernandez D, Medina-Ramirez R, Vilchez-Barrera M, Etopa-Bitata P, Del Pino Quintana-Montesdeoca M, Baez-Suarez A, Freixinet JL. Effect of transcutaneous electro-stimulation in postoperative rehabilitation pain treatment in thoracic surgery: a randomized clinical trial. Trials. 2024 Dec 19;25(1):839. doi: 10.1186/s13063-024-08613-9.

  PMID: 39702343 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Daniel David Álamo Arce, P.T.

  Teaching professor and researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy

Model Details: Randomized trial

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 16, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 8, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)