NCT05617235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

November 1, 2022

Last Update Submit

November 14, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 from Baseline Pain Score at 4 weeks.

  • 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 from Baseline Pulmonary Function at 4 weeks.

  • 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 from Baseline Pulmonary Strenght at 4 weeks.

  • 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.

    Change from Baseline Quality of Life at 4 weeks.

Secondary Outcomes (3)

  • Height in Meters

    Initial assessment before surgery

  • Weight in Kilograms

    Initial assessment before surgery

  • Body Mass Index (BMI) in kg/m^2

    Initial assessment before surgery.

Study Arms (2)

Conventional Physiotherapy and Rehabilitation

NO INTERVENTION

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.

Kinesiology taping

EXPERIMENTAL

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: 1. In order to stimulate the facilitation of the diaphragmatic function, a 5 cm wide kinesiological tape was applied on the skin. 2. Taping was applied to the latissimus dorsi and serratus anterior muscles, which were cut during the thoracotomy. 3. 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.

Device: Kinesiology taping

Interventions

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: 1. In order to stimulate the facilitation of the diaphragmatic function 2. Taping was applied to the latissimus dorsi and serratus anterior muscles, which were cut during the thoracotomy. 3. 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.

Kinesiology taping

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Who had chest trauma, thoracotomy or tube thoracostomy
  • Who had not complying with the pulmonary function test
  • Who are allergic to the tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neriman Temel Aksu

Antalya, 07060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Neriman Temel Aksu

    Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 15, 2022

Study Start

February 6, 2019

Primary Completion

October 30, 2022

Study Completion

November 1, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations