HyperkyphosisNCT06418334
Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis
An observational study of Hyperkyphosis and Spine Deformity, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Hyperkyphosis, Spine Deformity, Diaphragm Issues
- What is being tested?
- Thoracal hyperkyphosis study form, Scoliosis graphy and Pulmonary function test
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Child, Adult
Study population: It will consist of participants with thoracal hyperkyphosis deformity who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpaşa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information of all individuals involved in the recruitment will be collected.
Who may be able to join
- Increased thoracal kyphosis (thoracic hyperkyphosis)
- Being between the ages of 10-18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperkyphosis, Spine Deformity, Diaphragm Issues
- Being tested
- Thoracal hyperkyphosis study form, Scoliosis graphy, Pulmonary function test, Ultrasonographic Measurement
- Keywords
- Thoracal Hyperkyphosis, Diaphragma Thickness, Ultrasonographic Measurement
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracal hyperkyphosis study formDiagnostic test
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 graphyDiagnostic test
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 testDiagnostic test
Also called Spirometry 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 MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Thoracal hyperkyphosis study form; Diagnostic Test: Scoliosis graphy; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 month of applying to the outpatient clinic
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.
Measured: Within 1 month of applying to the outpatient clinic
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.
Measured: Within 1 month of applying to the outpatient clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Oct 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Meryem Guneser Gulec, MD, Study chair, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation DepartmentCansu Ozkan, MD, Study chair, Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418334
- Sponsor's protocol ID
- 109
- Status last verified
- Apr 2025
- First submitted
- 11 Jan 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.
Publications
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.
PubMed 32099278Karaali 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.
PubMed 33550575Wang 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.
PubMed 26644703Oke D, Karakullukcuoglu Z, Gulec MG, Ozkan C. Ultrasonographic evaluation of diaphragmatic thickness in adolescents with thoracic hyperkyphosis: new horizons in diagnosis. BMC Musculoskelet Disord. 2026 Jan 2;27(1):92. doi: 10.1186/s12891-025-09462-6.
PubMed 41484972
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis
- ClinicalTrials.gov ID
- NCT06418334
- Acronym / sponsor ID
- 109
- Conditions
- Hyperkyphosis, Spine Deformity, Diaphragm Issues
- Keywords
- Thoracal Hyperkyphosis, Diaphragma Thickness, Ultrasonographic Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity | – | Diagnostic Test: Thoracal hyperkyphosis study form, Diagnostic Test: Scoliosis graphy, Diagnostic Test: Pulmonary function test, Diagnostic Test: Ultrasonographic MeasurementThoracal 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- It will consist of participants with thoracal hyperkyphosis deformity who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpaşa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information of all individuals involved in the recruitment will be collected.
Key inclusion criteria (2 listed)
- Increased thoracal kyphosis (thoracic hyperkyphosis)
- Being between the ages of 10-18
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracal hyperkyphosis study formThoracal 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. | Diagnostic test | Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity |
| Scoliosis graphyPatients 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. | Diagnostic test | Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity |
| Pulmonary function testAlso: Spirometry Function TestPulmonary 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. | Diagnostic test | Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity |
| Ultrasonographic MeasurementDiaphragm 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. | Diagnostic test | Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Results publication: PubMed 32099278Jagger 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.
- Results publication: PubMed 33550575Karaali 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.
- Results publication: PubMed 26644703Wang 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.
- Derived from this study: PubMed 41484972Oke D, Karakullukcuoglu Z, Gulec MG, Ozkan C. Ultrasonographic evaluation of diaphragmatic thickness in adolescents with thoracic hyperkyphosis: new horizons in diagnosis. BMC Musculoskelet Disord. 2026 Jan 2;27(1):92. doi: 10.1186/s12891-025-09462-6.
- Individual participant dataSharing planned: No. The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.
Related trials for Hyperkyphosis
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
Hyperkyphosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Kinesio Taping in Young Adults With Thoracic Hyperkyphosis
Thoracic Hyperkyphosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Guneser Gulec, MD study chair
Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Cansu Ozkan, MD study chair
Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkyphosis and Spine Deformity, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracal hyperkyphosis study form (time frame: Within 1 month of applying to the outpatient clinic). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418334, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.