Clinical trial NCT05617235: Kinesiology Taping After Thoracotomy
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
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Thoracotomy
Pulmonary Function
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of Pain Score
timeFrame: Change from Baseline Pain Score at 4 weeks.
measure: Change of Pulmonary Function
timeFrame: Change from Baseline Pulmonary Function at 4 weeks.
measure: Change of Respiratory Muscle Strength
timeFrame: Change from Baseline Pulmonary Strenght at 4 weeks.
measure: Change of Quality of Life
timeFrame: Change from Baseline Quality of Life at 4 weeks.
Secondary outcomes:
measure: Height in Meters
timeFrame: Initial assessment before surgery
measure: Weight in Kilograms
timeFrame: Initial assessment before surgery
measure: Body Mass Index (BMI) in kg/m^2
timeFrame: Initial assessment before surgery.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Neriman Temel Aksu
Study officials:
affiliation: Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu
name: Neriman Temel Aksu
role: PRINCIPAL_INVESTIGATOR
References: