ThoracicNCT04964973
Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery.
A study testing Experimental in people with Thoracic and Postoperative Pain, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic, Postoperative Pain
- What is being tested?
- Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 8 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent.
- Affected by pulmonary or mediastinal pathology.
- Who have required thoracic surgery.
Who cannot join
- Patients with pacemakers.
- Diseases with chronic need for analgesic drug.
- History of drug addiction.
- Patients who do not require hospital readmission after surgery.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital of Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35008
About this study
Official title: 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?
Read the 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).
- Conditions
- Thoracic, Postoperative Pain
- Being tested
- Control, Experimental, Placebo
- Keywords
- Rehabilitation, Transcutaneous Electric Nerve Stimulation, Thoracic surgery, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
Post-surgical physiotherapeutic activity.
ExperimentalDevice
Post-surgical physiotherapeutic activity with the application of the technique
PlaceboDevice
Post-surgical physiotherapeutic activity with the application of the non-activated technique
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 1. Control group. Patients have performed the conventional postsurgical program without adding TENS. Receives: 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. Receives: 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 Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel David Álamo Arce, University of Las Palmas de Gran Canaria
- Investigators
- Daniel David Álamo Arce, P.T., Principal investigator, Teaching professor and researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964973
- Sponsor's protocol ID
- CEIC 15012
- Status last verified
- Nov 2022
- First submitted
- 6 Jul 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.
PubMed 21084984Husch 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.
PubMed 32036406Fiorelli 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.
PubMed 22219414Melzack 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.
PubMed 5320816Solak 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.
PubMed 17410506Alamo-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.
PubMed 39702343
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04964973
- Acronym / sponsor ID
- CEIC 15012
- Conditions
- Thoracic, Postoperative Pain
- Keywords
- Rehabilitation, Transcutaneous Electric Nerve Stimulation, Thoracic surgery, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Control1. Control group. Patients have performed the conventional postsurgical program without adding TENS. |
| Experimental Group | Experimental | Device: ExperimentalExperimental 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 | Device: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed the informed consent.
- Affected by pulmonary or mediastinal pathology.
- Who have required thoracic surgery.
Key exclusion criteria (4 listed)
- Patients with pacemakers.
- Diseases with chronic need for analgesic drug.
- History of drug addiction.
- Patients who do not require hospital readmission after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlPost-surgical physiotherapeutic activity. | Device | Control Group |
| ExperimentalPost-surgical physiotherapeutic activity with the application of the technique | Device | Experimental Group |
| PlaceboPost-surgical physiotherapeutic activity with the application of the non-activated technique | Device | Placebo Group |
Primary outcome
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
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 21084984Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.
- Background: PubMed 32036406Husch 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.
- Background: PubMed 22219414Fiorelli 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.
- Background: PubMed 5320816Melzack 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.
- Background: PubMed 17410506Solak 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.
- Derived from this study: PubMed 39702343Alamo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel David Álamo Arce, P.T. principal investigator
Teaching professor and researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Thoracic and Postoperative Pain, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry (time frame: Six month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04964973, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.