NCT06418334

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

January 11, 2024

Last Update Submit

April 27, 2025

Conditions

Keywords

Thoracal HyperkyphosisDiaphragma ThicknessUltrasonographic Measurement

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

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.

Diagnostic Test: Thoracal hyperkyphosis study formDiagnostic Test: Scoliosis graphyDiagnostic Test: Pulmonary function testDiagnostic Test: Ultrasonographic Measurement

Interventions

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 aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity
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.

Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity

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.

Also known as: Spirometry Function Test
Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity

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.

Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Increased thoracal kyphosis (thoracic hyperkyphosis)
  • Being between the ages of 10-18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deniz Oke

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • Oke 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.

MeSH Terms

Conditions

Kyphosis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

May 17, 2024

Study Start

October 1, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations