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Completed

NCT Number: NCT05617235

Kinesiology Taping After Thoracotomy

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neriman Temel Aksu

Antalya, 07060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesiology Taping

Device

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 outcomes

  1. Change of Pain Score

    Time frame: Change from Baseline Pain Score at 4 weeks.

    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.

  2. Change of Pulmonary Function

    Time frame: Change from Baseline Pulmonary Function at 4 weeks.

    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.

  3. Change of Respiratory Muscle Strength

    Time frame: Change from Baseline Pulmonary Strenght at 4 weeks.

    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.

  4. Change of Quality of Life

    Time frame: Change from Baseline Quality of Life at 4 weeks.

    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 outcomes

  1. Height in Meters

    Time frame: Initial assessment before surgery

    The height of all subjects in meters (m) will be noted before the surgery.

  2. Weight in Kilograms

    Time frame: Initial assessment before surgery

    The weight of all subjects in kilograms (kg) will be noted before the surgery.

  3. Body Mass Index (BMI) in kg/m^2

    Time frame: Initial assessment before surgery.

    Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Investigation of The Effect of Kinesiology Tape on Pain, Respiratory Function and Respiratory Muscle Strength After Thoracotomy-A Randomized Controlled Study

Acronym: Taping

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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