Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73,000
- 试验地点
- 1
- 主要终点
- Scoliosis Curve Angle
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• 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
结局指标
主要结局
Scoliosis Curve Angle
时间窗: 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
Angle of Trunk Rotation
时间窗: 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.
次要结局
- Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis(Baseline and every 24 months (±1 month) until study completion, up to 96 months.)
- Daily Near-Work Duration (UVD) Assessed by 30-Minute Block Questionnaire(Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.)
- Axial Length (AL) Growth Rate Measured by Swept-Source OCT(Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.)
研究者
Xiangyang Wang
M.D., Chief physician, Doctorial supervisor
Second Affiliated Hospital of Wenzhou Medical University