Scoliosis IdiopathicNCT06992622
Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis
An observational study of Scoliosis Idiopathic and Myopia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Scoliosis Idiopathic, Myopia, Vision Disorders
- How many people
- 73,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 30 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescents participating in the Zhejiang Adolescent Spine and Vision Health Screening Program, China
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000
Wenzhou, Zhejiang, 325600
Xiangyang Wang, 86-13506663458, Xiangyangwang@wmu.edu.cn
About this study
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.
Read the detailed description
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
- Scoliosis Idiopathic, Myopia, Vision Disorders
- Keywords
- Adolescent idiopathic scoliosis, Longitudinal progression, Spine-vision comorbidity
- Medical subject headings
- Myopia, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IS with Myopia | diopathic scoliosis with untreated myopia | |
| IS without Myopia | diopathic scoliosis without myopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Curve Angle
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
Measured: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]
Angle of Trunk Rotation
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.
Measured: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]
Secondary outcomes (3)
Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis
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.
Measured: 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
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).
Measured: 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
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.
Measured: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start30 Sep 2024
- Primary completion30 Sep 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyang Wang, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Xiangyang Wang, Study chair, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992622
- Sponsor's protocol ID
- SAHoWMU-CR2025-08-220
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis
- ClinicalTrials.gov ID
- NCT06992622
- Acronym / sponsor ID
- SAHoWMU-CR2025-08-220
- Conditions
- Scoliosis Idiopathic, Myopia, Vision Disorders
- Keywords
- Adolescent idiopathic scoliosis, Longitudinal progression, Spine-vision comorbidity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 73,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IS with Myopia | – | –diopathic scoliosis with untreated myopia |
| IS without Myopia | – | –diopathic scoliosis without myopia |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescents participating in the Zhejiang Adolescent Spine and Vision Health Screening Program, China
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- • Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
3 secondary outcomes
Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis
Time frame: 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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangyang Wang study chair
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Myopia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 May 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangyang Wang (86-13506663458, Xiangyangwang@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.]). The study lists 2 primary outcomes in all. 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 28 May 2025.