Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis

Spine Deformity Clinical Trial

Official title:

Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418334
• Other study ID #: 109
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: April 2024
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: Deniz Oke, MD
• Phone: +90 532 430 69 50
• Email: dr_denizoke[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Spinal deformity is common in childhood and adolescence. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. The investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities.

Description:

Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracal kyphosis deformity with various etiologies.

Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale.

The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages.

Based on this, the investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities, to show whether there is any relationship between increased kyphosis deformity and diaphragmatic thickness, and to show whether there is any change in diaphragmatic thickness before or after the treatment for kyphosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 15, 2024
• Est. primary completion date: May 4, 2024
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Increased thoracal kyphosis (thoracic hyperkyphosis)

• Being between the ages of 10-18

Exclusion Criteria:

• Congenital spinal, costal and diaphragmatic anomalies

• Neuromuscular disease

• Respiratory system diseases that affect lung functions

• Patients who cannot cooperate with spirometry.

• Having surgery to the chest wall or spine

Related Conditions & MeSH terms

• Diaphragm Issues
• Hyperkyphosis
• Kyphosis
• Spine Deformity

Intervention

Diagnostic Test:
• Thoracal hyperkyphosis study form
Thoracal hyperkyphosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with chest deformity will be filled in detail.
• Scoliosis graphy
Patients whose forward bending test and clinical evaluation results are compatible with hyperkyphosis and scoliosis radiographs are requested. Coronal, sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs.
• Pulmonary function test
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help participant healthcare provider diagnose and decide the treatment of certain lung disorders. The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
• Ultrasonographic Measurement
Diaphragm thickness will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter-cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.

Locations

Country	Name	City	State
Turkey	Deniz Oke	Istanbul	Gaziosmanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Jagger F, Tsirikos AI, Blacklock S, Urquhart DS. Adaptation to reduced lung function in children and young people with spinal deformity. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):191-195. doi: 10.1016/j.jcot.2019.12.013. Epub 2020 Jan 3. — View Citation

Karaali E, Ciloglu O, Gorgulu FF, Ekiz T. Ultrasonographic measurement of diaphragm thickness in patients with severe thoracic scoliosis. J Ultrasound. 2021 Mar;24(1):75-79. doi: 10.1007/s40477-020-00536-w. Epub 2021 Feb 7. — View Citation

Wang JS. Effect of joint mobilization and stretching on respiratory function and spinal movement in very severe COPD with thoracic kyphosis. J Phys Ther Sci. 2015 Oct;27(10):3329-31. doi: 10.1589/jpts.27.3329. Epub 2015 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thoracal hyperkyphosis study form	Thoracal hyperkyphosis study form consisting of clinical and radiological measurements of patients aged 8-18 years who applied to the outpatient clinic with chest deformity will be filled in detail. Coronal, sagittal balance; coronal and sagittal Cobb angles (degree) (degree between upper end vertebral line of thoracal 3 'T3' and lower end vertebral line of 'T12') will be measured from posterior-anterior (PA) and lateral scoliosis radiographs.	Within 1 month of applying to the outpatient clinic
Primary	Pulmonary function test	The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second) (Liter-L), FEV1 (%predicted) (percentage), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted) (percentage), FEV1/FVC (%) and FEV1/FVC (%predicted) (percentage) will be evaluated. The arithmetic average of the results of these three measurements will be taken.	Within 1 month of applying to the outpatient clinic
Primary	Ultrasonographic Measurement	Diaphragm thickness (centimeter-cm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter-cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.	Within 1 month of applying to the outpatient clinic