Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
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:
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:
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:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 1. Control group. Patients have performed the conventional postsurgical program without adding TENS. |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Device | Post-surgical physiotherapeutic activity. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel David Álamo Arce, P.T. | Teaching professor and researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria | Las Palmas | 35008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21084984 | Background | Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175. | |
| 32036406 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2021 | Nov 8, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2021 | Nov 8, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Randomized trial
Not provided
Not provided
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.
| Experimental |
| Device |
Post-surgical physiotherapeutic activity with the application of the technique |
|
| Placebo | Device | Post-surgical physiotherapeutic activity with the application of the non-activated technique |
|
| 22219414 | 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. |
| 5320816 | 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. |
| 17410506 | 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. |
| 39702343 | Derived | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |