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

NCT ID: NCT06992622

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

73000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2032-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis Idiopathic Myopia Vision Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IS with Myopia

diopathic scoliosis with untreated myopia

No interventions assigned to this group

IS without Myopia

diopathic scoliosis without myopia

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiangyang Wang

M.D., Chief physician, Doctorial supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangyang Wang

Role: STUDY_CHAIR

Second Affiliated Hospital of Wenzhou Medical University

Locations

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

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangyang Wang

Role: CONTACT

86-13506663458

Facility Contacts

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Xiangyang Wang

Role: primary

86-13506663458

Other Identifiers

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SAHoWMU-CR2025-08-220

Identifier Type: -

Identifier Source: org_study_id

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