- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05651048
The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
December 6, 2022 updated by: MAKBULE KARCI, Istanbul University - Cerrahpasa (IUC)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İ̇stanbul, Turkey, 34540
- Istanbul University - Cerrahpasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion criteria for the study were to have undergone VATS lobectomy and to be aged between 18 and 75 years.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BEMER Group
BEMER application with routine treatment protocol
|
BEMER therapy and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
|
|
Experimental: Kinesiotape Group
Kinesiotape application with routine treatment protocol
|
Kinesiotape application and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
|
|
Experimental: Control Group
routine treatment protocol
|
Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Postoperative 4th day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
February 1, 2021
Study Completion (Anticipated)
December 20, 2022
Study Registration Dates
First Submitted
November 11, 2022
First Submitted That Met QC Criteria
December 6, 2022
First Posted (Estimate)
December 14, 2022
Study Record Updates
Last Update Posted (Estimate)
December 14, 2022
Last Update Submitted That Met QC Criteria
December 6, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICU-KARCI-3477
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.