Pain, Post OperativeNCT05651048
The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
A study testing BEMER Group and Kinesiotape Group in people with Pain, Post Operative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The literature indicates that postoperative pulmonary complications are seen when pain is not treated effectively after videothoracoscopy surgery (VATS). After surgery, physiotherapy and rehabilitation approaches are applied to prevent complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Post Operative
- What is being tested?
- BEMER Group and Kinesiotape Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 20 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for the study were to have undergone VATS lobectomy and to be aged between 18 and 75 years.
Who cannot join
- Presence of pacemaker, severe cardiac failure, severe arrhythmia
- Those with cooperative disorders
- Presence of neurological or orthopedic problems affecting the extremities
- Those with severe psychiatric disorders
- Failure to perform the operation according to the result of intraoperative tumor staging
- Patients who go out of the standard Analgesia protocol
- Patients who were taken back from the service to the intensive care unit
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul, 34540
About this study
Official title: The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and
The literature indicates that postoperative pulmonary complications are seen when pain is not treated effectively after videothoracoscopy surgery (VATS). After surgery, physiotherapy and rehabilitation approaches are applied to prevent complications. Bio-Electro-Magnetic-Energy-Regulation (BEMER) therapy uses low-frequency electromagnetic energy to regulate vasomotion in capillaries and increase microcirculation. BEMER therapy can be applied together with physiotherapy and rehabilitation. The aim of this study is to investigate the effectiveness of BEMER application, which is added to the physiotherapy and rehabilitation program applied after videothoracoscopy surgery.
- Conditions
- Pain, Post Operative
- Being tested
- Control Group, BEMER Group, Kinesiotape Group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
BEMER GroupOther
BEMER therapy and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
Kinesiotape GroupOther
Kinesiotape application and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
| Study group | Role | What they receive |
|---|---|---|
| BEMER Group | Experimental | BEMER application with routine treatment protocol Receives: Other: BEMER Group |
| Kinesiotape Group | Experimental | Kinesiotape application with routine treatment protocol Receives: Other: Kinesiotape Group |
| Control Group | Experimental | routine treatment protocol Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores
Change From Baseline in Pain Scores on the Visual Analog Scale at Postoperative 4th day
Measured: Postoperative 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Nov 2020
- Primary completion1 Feb 2021
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post OperativeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAKBULE KARCI, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651048
- Sponsor's protocol ID
- ICU-KARCI-3477
- Status last verified
- Dec 2022
- First submitted
- 11 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and
- ClinicalTrials.gov ID
- NCT05651048
- Acronym / sponsor ID
- ICU-KARCI-3477
- Conditions
- Pain, Post Operative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 14 Dec 2022 (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.
The literature indicates that postoperative pulmonary complications are seen when pain is not treated effectively after videothoracoscopy surgery (VATS). After surgery, physiotherapy and rehabilitation approaches are applied to prevent complications. Bio-Electro-Magnetic-Energy-Regulation (BEMER) therapy uses low-frequency electromagnetic energy to regulate vasomotion in capillaries and increase microcirculation. BEMER therapy can be applied together with physiotherapy and rehabilitation. The aim of this study is to investigate the effectiveness of BEMER application, which is added to the physiotherapy and rehabilitation program applied after videothoracoscopy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BEMER Group | Experimental | Other: BEMER GroupBEMER application with routine treatment protocol |
| Kinesiotape Group | Experimental | Other: Kinesiotape GroupKinesiotape application with routine treatment protocol |
| Control Group | Experimental | Other: Control Grouproutine treatment protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for the study were to have undergone VATS lobectomy and to be aged between 18 and 75 years.
Key exclusion criteria (7 listed)
- Presence of pacemaker, severe cardiac failure, severe arrhythmia
- Those with cooperative disorders
- Presence of neurological or orthopedic problems affecting the extremities
- Those with severe psychiatric disorders
- Failure to perform the operation according to the result of intraoperative tumor staging
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 |
|---|---|---|
| Control GroupPhysiotherapy and Rehabilitation Program After Videothoracoscopy Surgery | Other | Control Group |
| BEMER GroupBEMER therapy and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery | Other | BEMER Group |
| Kinesiotape GroupKinesiotape application and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery | Other | Kinesiotape Group |
Primary outcome
Change From Baseline in Pain Scores
Time frame: Postoperative 4th day
Change From Baseline in Pain Scores on the Visual Analog Scale at Postoperative 4th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEMER Group and Kinesiotape Group in people with Pain, Post Operative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Dec 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
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?
Change From Baseline in Pain Scores (time frame: Postoperative 4th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2022.