- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06418334
Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zeynel Karakullukcuoglu, MD
- Phone Number: +90 541 216 61 16
- Email: zeynel@uludag.edu.tr
Study Contact Backup
- Name: Deniz Oke, MD
- Phone Number: +90 532 430 69 50
- Email: dr_denizoke@hotmail.com
Study Locations
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Gaziosmanpasa
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Istanbul, Gaziosmanpasa, Turkey, 34255
- Recruiting
- Deniz Oke
-
Contact:
- Zeynel Karakullukcuoglu, MD
- Phone Number: +90 541 216 61 16
- Email: zeynel@uludag.edu.tr
-
Contact:
- Meryem Guneser Gulec, MD
- Phone Number: +90 530 567 88 32
- Email: drmeryemgunesergulec@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity
Thoracal Hyperkyphosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity and applied to the scoliosis outpatient clinicwill be filled in detail.
|
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.
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 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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thoracal hyperkyphosis study form
Time Frame: Within 1 month of applying to the outpatient clinic
|
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
|
Pulmonary function test
Time Frame: Within 1 month of applying to the outpatient clinic
|
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
|
Ultrasonographic Measurement
Time Frame: Within 1 month of applying to the outpatient clinic
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Meryem Guneser Gulec, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
- Study Chair: Cansu Ozkan, MD, Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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