ClinicalTrials.gg
CompletedNCT07117448Updated Aug 12, 2025

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

An observational study in Scheuermann Disease, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
51
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Kyphosis with a site in Turkey — 9 open to participants now, 10 under way, none of them phase 3. Kyphosis · Turkey.

Enrollment
9th of 14
51 · median 57
Started
2024
with 4 others
Observational
14 of 35
2 open now
Registered
23rd of 35
by date

Among the 35 studies in Kyphosis with a site in Turkey, this one is the 9th largest by enrollment of the 14 observational ones that give a count, is one of 5 that started in 2024, is one of 14 observational ones, and was the 23rd registered.

Kyphosis

132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.

Browse Kyphosis studies →

Open to participants now

9 of the 35 studies in Kyphosis with a site in Turkey are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 20 Kyphosis studies recruiting now, 7 (35%) set no upper age limit and 12 (60%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.

This study: 10 Years to 18 Years · all sexes · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • Scheuermann Disease

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Keywords

  • Kyphosis
  • Balance
  • Sagittal balance
  • Spinopelvic parameters
  • Scheuermann Disease
04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • obtained from participants and/or guardians

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
51 participants (actual)
Target follow-up
8 Months
Patient registry
Yes

Groups and cohorts

  • Scheuermann's Kyphosis Group

    Adolescents diagnosed with Scheuermann's kyphosis according to Sorensen criteria

  • Healthy Control Group

    Age- and sex-matched healthy adolescents with no spinal deformity

06

What researchers measure

Primary outcomes

  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.

    Time frame: At enrollment (Day 0, cross-sectional)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: At enrollment (Day 0)

07

Study locations

1 site
  • Fatih Sultan Mehmet Training and Research Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2024 to primary completion in Mar 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2025
First posted
Aug 12, 2025
StartActual
Oct 10, 2024
Primary completionActual
Mar 10, 2025
CompletionActual
May 10, 2025
Last update
Aug 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07117448
Responsible party
Sılanur Güney Çamlıca (Medical Doctor, Fatih Sultan Mehmet Training and Research Hospital) — Principal investigator
First posted
Aug 12, 2025
Start date
Oct 10, 2024
Primary completion
Mar 10, 2025
Completion
May 10, 2025
Last update
Aug 12, 2025

Study contacts

sılanur güney çamlıca, medical doctor
principal investigator · Resident University of Health Sciences, FSM Training and Research Hospital, Istanbul

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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