search
Back to results

Kinesiology Taping After Thoracotomy (Taping)

Primary Purpose

Post Operative Pain, Thoracotomy, Pulmonary Function

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiology taping
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neriman Temel Aksu

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Physiotherapy and Rehabilitation

Kinesiology taping

Arm Description

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.

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: In order to stimulate the facilitation of the diaphragmatic function, a 5 cm wide kinesiological tape was applied on the skin. Taping was applied to the latissimus dorsi and serratus anterior muscles, which were cut during the thoracotomy. In addition, kinesiology taping can be performed on the trigger pain point of the patient (usually above the pectoralis major). 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.

Outcomes

Primary Outcome Measures

Change of Pain Score
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 of Pulmonary Function
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.
Change of Respiratory Muscle Strength
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.
Change of Quality of Life
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.

Secondary Outcome Measures

Height in Meters
The height of all subjects in meters (m) will be noted before the surgery.
Weight in Kilograms
The weight of all subjects in kilograms (kg) will be noted before the surgery.
Body Mass Index (BMI) in kg/m^2
Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.

Full Information

First Posted
November 1, 2022
Last Updated
November 14, 2022
Sponsor
Akdeniz University
search

1. Study Identification

Unique Protocol Identification Number
NCT05617235
Brief Title
Kinesiology Taping After Thoracotomy
Acronym
Taping
Official Title
Investigation of The Effect of Kinesiology Tape on Pain, Respiratory Function and Respiratory Muscle Strength After Thoracotomy-A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Effective pain control after thoracotomy increases the patient's respiratory functions and related quality of life, reduces the length of hospital stay and the amount of analgesia use. Kinesiology taping has been used in sports injuries for many years and has been used in recent years to reduce pain after major surgery. This study was conducted to examine the effect of kinesiology taping on pain, respiratory function and respiratory muscle strength in patients who underwent thoracotomy.In this prospective randomized controlled experimental study, individuals between the ages of 20-75 who underwent thoracotomy with posterolateral thoracotomy and who agreed to participate in the study were included. Unlike the control group, kinesiology taping was applied to the study group for 7 days after surgery. Pain, respiratory functions, respiratory muscle strength, amount of analgesic drug use, and quality of life were evaluated preoperatively, postoperative day 0, before tape application, postoperative 1st day, postoperative 2nd day, postoperative 7th day and postoperative 1st month.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Thoracotomy, Pulmonary Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physiotherapy and Rehabilitation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Kinesiology taping
Arm Type
Experimental
Arm Description
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: In order to stimulate the facilitation of the diaphragmatic function, a 5 cm wide kinesiological tape was applied on the skin. Taping was applied to the latissimus dorsi and serratus anterior muscles, which were cut during the thoracotomy. In addition, kinesiology taping can be performed on the trigger pain point of the patient (usually above the pectoralis major). 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.
Intervention Type
Device
Intervention Name(s)
Kinesiology taping
Intervention Description
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: In order to stimulate the facilitation of the diaphragmatic function Taping was applied to the latissimus dorsi and serratus anterior muscles, which were cut during the thoracotomy. In addition, kinesiology taping can be performed on the trigger pain point of the patient . After 3-4 days, the tape was renewed. Thus, taping was done twice for each patient. The bands were removed at 1 week postoperatively.
Primary Outcome Measure Information:
Title
Change of Pain Score
Description
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.
Time Frame
Change from Baseline Pain Score at 4 weeks.
Title
Change of Pulmonary Function
Description
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.
Time Frame
Change from Baseline Pulmonary Function at 4 weeks.
Title
Change of Respiratory Muscle Strength
Description
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.
Time Frame
Change from Baseline Pulmonary Strenght at 4 weeks.
Title
Change of Quality of Life
Description
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.
Time Frame
Change from Baseline Quality of Life at 4 weeks.
Secondary Outcome Measure Information:
Title
Height in Meters
Description
The height of all subjects in meters (m) will be noted before the surgery.
Time Frame
Initial assessment before surgery
Title
Weight in Kilograms
Description
The weight of all subjects in kilograms (kg) will be noted before the surgery.
Time Frame
Initial assessment before surgery
Title
Body Mass Index (BMI) in kg/m^2
Description
Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.
Time Frame
Initial assessment before surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neriman Temel Aksu
Organizational Affiliation
Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neriman Temel Aksu
City
Antalya
ZIP/Postal Code
07060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kinesiology Taping After Thoracotomy

We'll reach out to this number within 24 hrs