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Scheuermann DiseaseNCT07117448

Clinical and Radiological Correlates of Balance, Pain and Body Image in Adolescents With Scheuermann's Kyphosis

An observational study of Scheuermann Disease, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to evaluate the relationship between sagittal and spinopelvic radiological parameters of the spine and clinical outcomes in adolescents with Scheuermann's kyphosis (SK) by assessing dynamic and static balance, pain, quality of life, and body image. Read more about this study

Who is it for?
Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Scheuermann Disease
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Oct 2024to 10 May 2025
How long will I take part?
8 Months
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
  • Healthy volunteers accepted
  • Child, Adult

Study population: Adolescents aged 10 to 18 years, including individuals diagnosed with Scheuermann's kyphosis and age- and sex-matched healthy controls. All participants were recruited from the department of physical medicine and rehabilitation

Who may be able to join

  • Adolescents aged 10 to 18 years
  • Diagnosis of Scheuermann's kyphosis based on Sorensen criteria (for patient group)
  • Healthy volunteers matched for age and sex (for control group)
  • Ability to understand and comply with study procedures
  • Informed consent obtained from participants and/or guardians

Who cannot join

  • Neuromuscular disorders
  • History of spinal surgery or traumatic spinal injury
  • Scoliosis > 15° (Cobb angle)
  • Vestibular, visual, or auditory impairments
  • Lower extremity musculoskeletal disorders affecting gait or balance
  • Cognitive or psychiatric conditions affecting participation
  • Use of orthotic devices or braces
  • Any other systemic condition affecting postural control

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Relationship Between Clinical and Radiological Parameters, Static and Dynamic Balance, Pain, Quality of Life and Body Image in Adolescents With Scheuermann's Kyphosis

The goal of this observational study is to evaluate the relationship between sagittal and spinopelvic radiological parameters of the spine and clinical outcomes in adolescents with Scheuermann's kyphosis (SK) by assessing dynamic and static balance, pain, quality of life, and body image. The main questions it aims to answer are: Is there a correlation between kyphosis severity, spinopelvic measurements, and balance scores in adolescents with Scheuermann's kyphosis? How do pain, body image, and quality of life relate to radiological parameters and clinical findings in these individuals? Are there significant differences in balance, spinopelvic parameters, body image, and quality of life between adolescents with Scheuermann's kyphosis and healthy controls?

Participants will undergo radiological evaluation of sagittal spine and spinopelvic parameters using standing lateral spinal radiographs, static and dynamic balance assessments to evaluate postural stability, pain assessment using validated pain scales, and quality of life and body image assessments through standardized questionnaires.

Researchers will compare Scheuermann's kyphosis patients and age-matched healthy controls to determine the impact of kyphosis severity on balance, body image, and quality of life.

Read the detailed description

Scheuermann's disease, also known as juvenile kyphosis or juvenile discogenic disease, is a hyperkyphotic condition of the spine involving the vertebral bodies and discs, defined by anterior wedging of 5 degrees or more in three or more consecutive vertebral bodies. Some studies suggest that a single wedged vertebra associated with irregular vertebral endplates is sufficient for diagnosis. The thoracic spine is most commonly affected, but involvement may also extend to the thoracolumbar/lumbar region. The estimated prevalence in the general population is 0.4-8%, with a similar male-to-female ratio.

The exact and universally accepted etiology of Scheuermann's kyphosis (SK) has yet to be determined. It is suggested that disproportionate vertebral endplate mineralization and ossification during growth lead to uneven vertebral body growth, ultimately resulting in kyphosis with the characteristic wedge-shaped vertebral bodies. Thoracic hyperkyphosis in individuals with flexible spines is typically compensated by non-structural hyperlordosis of the lumbar and cervical spine. The head and shoulders are positioned forward, and the deformity is relatively fixed, not resolving with hyperextension. Neurological examination is almost always normal. The diagnosis is often made in adolescents aged 12 to 17 years when parents notice a postural deformity or hunchback appearance. Pain in the affected hyperkyphotic region may be the reason for initial evaluation, which may worsen with standing and activity but typically resolves upon skeletal maturity. The extent and severity of pain vary based on the patient's age, disease stage, kyphosis location, and deformity severity. In addition to spinal deformity, these patients often experience tightness in the pectoral, hamstring, and iliopsoas muscles.

For imaging, standard standing lateral and anteroposterior spinal radiographs are essential. The kyphosis angle is measured on lateral radiographs using the Cobb method. The normal range of thoracic kyphosis, according to the Scoliosis Research Society (SRS), is 20°-40° using the Cobb method. Based on the apex of kyphosis, SK is classified as thoracic type if the apex is at T7-T9, thoracolumbar type if at T10-T12, and lumbar type in cases with progressive low back pain, decreased lumbar lordosis, and characteristic radiographic changes.

The importance of sagittal profile assessment in spinal pathologies is increasing. Neutral sagittal balance is evaluated on standing lateral spinal radiographs. Kyphotic deformities disrupt neutral sagittal balance. Increased kyphotic deformity causes the head to shift forward beyond the feet and pelvis, resulting in positive sagittal imbalance.

Balance includes static balance, which is the ability to maintain the body in a specific position; dynamic balance, which is the ability to maintain balance during movement; and postural stability, which is the ability to maintain orientation in relation to the surrounding environment. This mechanism involves a neuromuscular interaction that integrates information from proprioceptive, visual, and vestibular inputs to generate an appropriate motor response to keep the body's center of mass within the base of support. Morphological spinal deformities can alter head position, lead to asymmetric muscle activity around the spine, and shift the body's center of mass, affecting postural stability and balance performance. Therefore, postural stability and balance performance in upright standing may be altered in individuals with spinal deformities such as scoliosis and hyperkyphosis. A kyphotic posture may cause the center of mass to shift forward beyond stability limits, reducing postural balance and increasing fall risk. Dysfunction in somatosensory pathways may impair postural control mechanisms, potentially influencing the etiology or progression of scoliosis.

The literature associates different scoliotic curvatures with altered posturography and postural sway under both static and dynamic conditions, indicating varying degrees of balance impairment. Some studies suggest that the degree of balance dysfunction correlates with the severity of the scoliotic curvature. While previous studies on SK have examined the relationship between radiographic findings and clinical symptoms, the impact of abnormal thoracic kyphotic posture on static balance, and spinopelvic parameters between SK patients and age-matched controls, no study has compared kyphosis severity and spinopelvic measurements with balance scores, body image, and quality of life.

This study aims to investigate the relationship between sagittal and spinopelvic radiological parameters and clinical findings in adolescents with Scheuermann's kyphosis by evaluating dynamic and static balance, pain, quality of life, and body image. Additionally, changes in these parameters will be compared with those of healthy adolescents.

Keywords
Kyphosis, Balance, Sagittal balance, Spinopelvic parameters, Scheuermann Disease
Medical subject headings
Scheuermann Disease, Kyphosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07117448
Study groupRoleWhat they receive
Scheuermann's Kyphosis GroupAdolescents diagnosed with Scheuermann's kyphosis according to Sorensen criteria
Healthy Control GroupAge- and sex-matched healthy adolescents with no spinal deformity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance Parameters Assessed by Multiple Modalities

    Clinical balance tests will assess static postural control by recording the duration (in seconds) the participant maintains the test position.

    Stabilometric platform will measure postural sway parameters during quiet stance. Computerized Dynamic Posturography (CDP) will provide composite scores reflecting balance performance under various sensory conditions Each method will be analyzed and reported separately. Additionally, agreement and correlation between clinical balance tests and device-based measurements (stabilometric platform and CDP) will be evaluated.

    Measured: At enrollment (Day 0, cross-sectional)

Secondary outcomes (4)
  1. Pain Level Assessed by Numeric Rating Scale (NRS)

    Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.

    Measured: At enrollment (Day 0)

  2. Health-Related Quality of Life Assessed by SRS-22r

    Quality of life will be evaluated using the SRS-22r questionnaire, consisting of 22 items covering five domains: function, pain, self-image, mental health, and satisfaction. Each item is scored from 1 to 5. Higher scores indicate better quality of life.

    Measured: At enrollment (Day 0)

  3. Body Image Perception Assessed by SAAS

    Body image perception will be evaluated using the Social Appearance Anxiety Scale (SAAS), a 16-item self-report scale. Items are scored on a 5-point Likert scale from 1 (not at all) to 5 (extremely). Higher scores reflect greater appearance-related anxiety and more negative body image.

    Measured: At enrollment (Day 0)

  4. Correlation Between Clinical and Radiological Parameters

    Correlations will be analyzed between clinical outcome measures (pain via NRS, quality of life via SRS-22r, and body image via SAAS) and radiographic parameters (e.g., kyphosis angle, pelvic incidence, sagittal vertical axis). Statistical analyses will include correlation coefficients to assess the strength and direction of associations.

    Measured: At enrollment (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start10 Oct 2024
  3. Primary completion10 Mar 2025
  4. Study completion10 May 2025

Resources

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
Cross-sectional
Enrolment
51 participants (actual)
Target duration
8 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117448
Sponsor's protocol ID
24/543
Status last verified
Aug 2025
First submitted
18 Jun 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Scheuermann Disease, run by Fatih Sultan Mehmet Training and Research 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 5 inclusion and 8 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 12 Aug 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?

Balance Parameters Assessed by Multiple Modalities (time frame: At enrollment (Day 0, cross-sectional)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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