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NCT Number: NCT06992622

Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis

The aim of study: 1. To investigate the prevalence of scoliosis, other spinal deformities, myopia, and visual impairments in adolescents (aged 6-18) in Zhejiang Province.

2.To track 8-year dynamic changes in spinal curvature and analyze associations between scoliosis, vision disorders, and potential risk factors.

3.To deliver scoliosis health education during screenings.

4.To mitigate scoliosis progression through early detection and intervention.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000

Wenzhou, Zhejiang, 325600, China

Location status: Recruiting

Location contact

Xiangyang Wang

CONTACT

[email protected]

86-13506663458

About this study

Scoliosis is the most common pediatric musculoskeletal disorder, affecting up to 4% of otherwise healthy children worldwide. Approximately 80-90% of cases are idiopathic scoliosis (IS), predominantly emerging during adolescence. While mild IS often causes no symptoms, moderate cases may lead to spinal deformity and mild respiratory dysfunction, with severe cases potentially resulting in cardiopulmonary compromise or even paralysis.

Despite extensive research exploring potential causes - including genetic, neuroendocrine, skeletal, muscular, postural, biomechanical and lifestyle factors - the underlying mechanisms of IS remain unclear. Bracing currently stands as the only proven conservative treatment to slow progression, yet 20-30% of braced patients still require eventual surgical correction. Adolescence represents both a critical window for rapid curve progression and the optimal period for effective intervention. Early screening has been demonstrated to significantly improve outcomes, highlighting the importance of preventive strategies during this developmental stage.

Recent studies across various populations have reported scoliosis prevalence rates ranging from 0.27% to 3.5%, with notable regional variations:

Singaporean studies found rates between 0.27%-2.49%

Greek research reported 1.7% prevalence

Large-scale US screening showed 0.9% prevalence

Chinese studies documented rates from 1.07% (Guangzhou) to 3.5% (Hong Kong)

Most existing research has been cross-sectional in design, lacking prospective data on curve progression patterns and associated risk factors.

This prospective cohort study aims to:1. To investigate the prevalence of scoliosis, other spinal deformities, myopia, and visual impairments in adolescents (aged 6-18) in Zhejiang Province.

2.To track 8-year dynamic changes in spinal curvature and analyze associations between scoliosis, vision disorders, and potential risk factors.

3.To deliver scoliosis health education during screenings.

4.To mitigate scoliosis progression through early detection and intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic scoliosis at their first clinic visit
  • Skeletally immature (Risser Sign 0-3)
  • Cobb angle between 11-40 degrees
  • Age between 6 and 17

Exclusion criteria

  • • Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis
  • History of previous spine surgery or spinal injury
  • Tumor or malignant tumor in the spine
  • Leg length discrepancy more than 20 mm
  • Previous diagnosis or treatment of SDB more than 6 months ago
  • Plans to relocate within the next 24 months

Treatment and study plan

Primary outcomes

  1. Scoliosis Curve Angle

    Time frame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]

    A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method

  2. Angle of Trunk Rotation

    Time frame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]

    In addition to spinal x-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.

Secondary outcomes

  1. Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis

    Time frame: Baseline and every 24 months (±1 month) until study completion, up to 96 months.

    MSE (diopters) will be calculated as [sphere + ½ cylinder] using autorefraction (Topcon KR-800) under cycloplegia (1% cyclopentolate). Myopia is defined as MSE ≤-0.50D. Triplicate measurements will be averaged per eye.

  2. Daily Near-Work Duration (UVD) Assessed by 30-Minute Block Questionnaire

    Time frame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.

    Daily near-work activities (reading/digital screen use) will be recorded through the validated 20-item Near-Vision Activity Questionnaire (NVAQ). Total daily UVD will be calculated by summing 30-minute activity blocks (maximum 16 blocks/day).

  3. Axial Length (AL) Growth Rate Measured by Swept-Source OCT

    Time frame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.

    AL (mm) will be measured using swept-source optical coherence tomography (Topcon Triton Plus). Annualized growth rates (mm/year) will be calculated by linear regression of AL against time between baseline and each follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangyang Wang

CONTACT

[email protected]

86-13506663458

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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