- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617235
Kinesiology Taping After Thoracotomy (Taping)
Investigation of The Effect of Kinesiology Tape on Pain, Respiratory Function and Respiratory Muscle Strength After Thoracotomy-A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are few studies showing the efficacy of kinesio taping for alleviating postoperative pain. Kinesio taping reduces postoperative pain, functional activity impairment, analgesic drug use, and lymphedema. Kinesio taping can improve cough reflex, secretion excretion, inspiratory muscle strength and respiratory function.Kinesio taping has been used in sports injuries for many years and has been used in recent years to reduce pain after major surgery. The aim of this study is to examine the effect of kinesio taping on pain, respiratory function and respiratory muscle strength after thoracotomy.This study was conducted on patients who underwent posterolateral thoracotomy. Written informed consent was obtained from each patient. The study protocol was approved by the Clinical Research Ethics Committee. The study was conducted in accordance with the principles of the Declaration of Helsinki. Patients were randomly assigned to 1:1 Kinesio taping group or control group using a computerized random number generator (GraphPad Software, San Diego, California) on postoperative day 0.The first group of the study consisted of patients in the Kinesio taping group, who underwent kinesio taping in addition to postoperative pulmonary rehabilitation and standard pain medication applications, and the second group consisted of patients in the control group, who underwent postoperative pulmonary rehabilitation and standard pain medication applications. On the postoperative 0th day, kinesiology taping was applied to the patients in the Kinesio taping group whose hemodynamic status was stable after extubation by an expert physiotherapist. The material we used for kinesio taping was Kinesio® Tex Gold™ (Kinesio Holding Corporation, Albuquerque, NM, USA), a 100% cotton, latex-free, 5 cm wide elastic band. A The kinesio tape can stay for 3-4 days if the patient does not develop any discomfort. After 3-4 days, the tape was renewed. The bands were removed at 1 week postoperatively.
The patients were followed from the preoperative period until discharge. For each patient, age, gender, weight and height measurements, educational status, type of surgery, whether there is any additional systemic disease, smoking, alcohol habits, medications they constantly use, previous operations, postoperative complications, surgical procedure, duration of operation, duration of anesthesia, Chest tube incision time and hospital stay were recorded.
The G*power sample size calculator was used to determine the sample size of the study. A sample size of 35 subjects for each group was estimated, assuming sample size, 0.05 type I error rate (α) and 90% power (1-α). A total of 88 patients were included to avoid possible loss or exclusion. Statistical analysis was performed using the SPSS version 23 statistical software program (SPSS Inc., Chicago, IL). In the comparisons between the two groups, Student's t test or Mann-Whitney U test was used. Chi-square test (Fisher exact test, 2-tailed) was used to compare categorical variables. Two-way analysis of variance was used in repeated measures to evaluate the change over time of the measured variables of the treatment and control groups and the group-time interactions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antalya, Turkey, 07060
- Neriman Temel Aksu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Who underwent thoracotomy with a posterolateral thoracotomy incision
- Who agreed to participate in the study, were aged 20-75 years
- Who had no known cerebrovascular disease
- Who had no morbid obesity and heart disease that would interfere with the study
- Who had no cognitive and cognitive impairments that would interfere with communication
Exclusion Criteria:
- Who had chest trauma, thoracotomy or tube thoracostomy
- Who had not complying with the pulmonary function test
- Who are allergic to the tape
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Conventional Physiotherapy and Rehabilitation
A training will be given including information about the postoperative recovery process, the purpose of respiratory physiotherapy and rehabilitation, the importance of physiotherapy and rehabilitation in the postoperative period, attention to speed up recovery and prevention of complications, breathing exercises, coughing training, posture exercises, early mobilization and its importance, and answering patient questions.The program includes progressive ambulation and progressive shoulder and rib cage exercises.
These exercises will be performed under the supervision of a physiotherapist from the first postoperative day.
The exercises will be advanced every day by increasing the number of repetitions.
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Experimental: Kinesiology taping
On the postoperative 0th day, kinesiology taping was applied to the patients in the study group whose hemodynamic status was stable after extubation by an expert physiotherapist. All tapes were applied by the same physiotherapist on clean and shaved skin (if necessary). Investigators applied kinesiology taping as described below:
The kinesiology tape can stay for 3-4 days if the patient does not develop any discomfort. After 3-4 days, the tape was renewed. Thus, taping was done twice for each patient. The bands were removed at 1 week postoperatively. |
On the postoperative 0th day, kinesiology taping was applied to the patients in the study group whose hemodynamic status was stable after extubation by an expert physiotherapist. Investigators applied kinesiology taping as described below:
After 3-4 days, the tape was renewed. Thus, taping was done twice for each patient. The bands were removed at 1 week postoperatively. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain Score
Time Frame: Change from Baseline Pain Score at 4 weeks.
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The Visual Analog Scale (VAS) was used as a one-dimensional scale for pain assessment. VAS is a self-administered, one-dimensional measure of pain intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of pain. Always "0" means no pain, while "10" means excruciating pain. When asked, patients touch a point corresponding to their degree of pain, and this mark indicates the degree of pain on the scale. Higher scores indicate greater pain severity. Preoperative, postoperative day 0, pre-taping, postoperative 1st day, postoperative 2nd day, postoperative 7th day and postoperative 1st month were evaluated. |
Change from Baseline Pain Score at 4 weeks.
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Change of Pulmonary Function
Time Frame: Change from Baseline Pulmonary Function at 4 weeks.
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Pulmonary function testing was performed using a digital spirometer (Pony FX, COSMED Inc., Italy) with subjects in a comfortable 90-degree sitting position.This test was repeated 3 times for each patient and the best value was recorded.
A 1-minute rest period was given between each test.
Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), 1 second forced expiratory volume to forced vital capacity (FEV1/FVC), peak expiratory flow (PEF), 25-75% forced expiratory flow (FEF25-75) have been recorded.
The tests were performed preoperatively, postoperative day 0, before tape application, postoperative day 1, postoperative day 2, postoperative day 7, and postoperative 1 month.
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Change from Baseline Pulmonary Function at 4 weeks.
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Change of Respiratory Muscle Strength
Time Frame: Change from Baseline Pulmonary Strenght at 4 weeks.
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Respiratory muscle strength was evaluated by measuring maximal inspiratory and maximal expiratory pressures with a portable intraoral pressure measuring device (Pony FX, COSMED Inc., Italy).
During the measurements, participants were verbally encouraged for maximum performance.
The maneuvers were repeated at least 5 times at intervals of at least 30 seconds, and the best among the measurements with a 5-10% difference was selected for analysis.
MIP and MEP values were determined as cmH2O.
The tests were performed preoperatively, postoperative day 0, before tape application, postoperative day 1, postoperative day 2, postoperative day 7, and postoperative 1 month.
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Change from Baseline Pulmonary Strenght at 4 weeks.
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Change of Quality of Life
Time Frame: Change from Baseline Quality of Life at 4 weeks.
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The Short Form-36 (SF-36) quality of life scoring was used to evaluate the quality of life of the patients.
SF-36 is a questionnaire with 8 subscales that gives information about the health status and quality of life of the person.
SF-36 was translated into Turkish in 1999.
Confirmation studies were conducted in different patient groups.The tests were applied in the preoperative period, at the postoperative 1st month.
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Change from Baseline Quality of Life at 4 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height in Meters
Time Frame: Initial assessment before surgery
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The height of all subjects in meters (m) will be noted before the surgery.
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Initial assessment before surgery
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Weight in Kilograms
Time Frame: Initial assessment before surgery
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The weight of all subjects in kilograms (kg) will be noted before the surgery.
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Initial assessment before surgery
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Body Mass Index (BMI) in kg/m^2
Time Frame: Initial assessment before surgery.
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Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.
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Initial assessment before surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neriman Temel Aksu, Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Akdeniz Univ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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