Adolescent Idiopathic Scoliosis (AIS)NCT07899294
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Jiawei Jiang at 1 site in China.
Trial summary
Taking the DIERS Spinal Moiré System as the primary tool, this study intends to establish an early warning model for adolescent scoliosis based on the system, verify the quantitative relationship between different body postures, three-dimensional pelvic parameters (inclination, rotation angle, torsion angle) and Cobb… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to Dec 2027
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescent patients with abnormal initial screening results from October 2025 to October 2027 will be selected for health education and advised to undergo further examinations in our hospital, followed by screening of those with abnormal results detected by the Spinal Moiré System.
Who may be able to join
- The volunteers recruited shall meet the diagnostic criteria for adolescent idiopathic scoliosis (AIS), with Lenke classification type 1 or 5 and a Cobb angle ranging from 10° to 45°.
Who cannot join
- Patients with concurrent other spinal diseases, a history of previous spinal surgery, or non-idiopathic scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Taking the DIERS Spinal Moiré System as the primary tool, this study intends to establish an early warning model for adolescent scoliosis based on the system, verify the quantitative relationship between different body postures, three-dimensional pelvic parameters (inclination, rotation angle, torsion angle) and Cobb angle progression, analyze the pelvic compensation characteristics of different Lenke classifications, establish a biomechanical prediction model, develop a dynamic risk assessment algorithm suitable for campus screening, formulate personalized rehabilitation programs under the guidance of DIERS parameters, evaluate the inhibitory effect of biofeedback training on scoliosis progression, and form a standardized "screening-diagnosis-intervention-management" process.
This project will develop and promote a screening and precision intervention system for adolescent scoliosis based on the DIERS Spinal Moiré System. The research outcomes of this project will assist the clinical diagnosis and treatment of adolescent idiopathic scoliosis, and propose a precision diagnosis and treatment strategy led by a quantitative data platform. The research findings of the project will be mainly submitted in the form of papers, with the plan to publish 1-2 papers indexed in SCI.
Read the detailed description
Against the backdrop of the Healthy China Strategy, the state attaches great importance to the health of adolescents and children. The "Healthy China 2030" Planning Outline puts forward the concept of "shifting the health threshold forward", identifying adolescents as a key population for prevention and control. On February 1, 2021, the Ministry of Education of China explicitly issued a document stating that scoliosis prevention should be incorporated into school health education and the monitoring network for common student diseases. In the same year, the National Health Commission released the Technical Guidelines for the Prevention and Control of Spinal Deformities in Children and Adolescents, which provides a reference framework for the prevention and control of spinal health in this population.
In this context, establishing a scientific and comprehensive policy for the screening and monitoring of adolescent scoliosis is of great practical significance for the early detection, early intervention and early treatment of scoliosis, as well as for safeguarding the spinal health of adolescents and children. However, domestically, only Shenzhen incorporated spinal screening into the compulsory education physical examination items in 2022, adopting the "five-step method" (including the use of a trunk rotation meter) for testing. In contrast, clinical palpation methods (such as the Adam's Forward Bend Test) have a specificity of only 60-70%, and traditional X-ray examinations are still widely used for subsequent rechecks.
Main Research Content Part 1: Establish a Comprehensive Scoliosis Screening Process Set up a research team and clarify the division of responsibilities among members. The Municipal Health Commission and Education Bureau shall demarcate the screening jurisdictions for each hospital; the Department of Spinal Surgery of the Municipal First People's Hospital shall take the lead in organizing training on on-site screening and monitoring for all participating hospitals, and formulate screening and monitoring procedures. The Municipal Education Bureau shall determine the number of subjects to be screened and specify the screening schedule. All hospitals shall collaborate with schools to organize screening for eligible adolescents and children. For children with abnormal results in the initial screening, it is recommended that they undergo an examination using the DIERS Spinal Moiré System.
Part 2: Analyze the Data from the Spinal Moiré System and Establish a Specialized Database for Adolescent Scoliosis For patients with abnormal results in the initial screening, it is recommended that they undergo a re-examination using the DIERS 4D Spinal Moiré System at Nantong First People's Hospital. All patients shall complete two sets of full-spine examinations with the DIERS 4D System in different positions: the standing position with arms hanging naturally and the standing position with elbows bent and hands on shoulders, in addition to a 4D motion examination. The DIERS 4D measurements shall be conducted independently by two physicians, with the average value taken as the final result. The operation of the DIERS 4D System shall be performed by professionally trained technicians, and the system will automatically generate the measured Cobb angle values and spine-pelvis related parameters. All collected data shall be deployed on a cloud computing server.
For the clinical data of all patients with adolescent idiopathic scoliosis (AIS), changes in the Cobb angle, vertebral rotation angle, pelvic parameters (pelvic torsion, pelvic rotation, pelvic inclination) and coronal plane balance measured by the DIERS 4D System in the two positions (arms hanging naturally vs. elbows bent and hands on shoulders) shall be observed, so as to analyze the impact of measurement position differences on the spine-pelvis morphological parameters. Pearson correlation analysis, Logistic regression and Wilcoxon test shall be adopted to evaluate parameter differences and high-risk factors.
Construction of the Prediction Model: Taking Cobb angle progression (an increase of ≥ 5° within 6 months) as the outcome indicator, variables including pelvic parameters, body posture difference parameters, age and bone age shall be incorporated. A biomechanical prediction model shall be established using multivariate regression analysis or machine learning algorithms (e.g., random forest). The model performance (e.g., AUC value, accuracy rate) shall be evaluated through internal validation (20% of the samples shall be selected for testing) and external validation (comparison with AIS data from other regions).
Part 3: Develop Personalized Treatment Plans for Adolescent Scoliosis Based on the Analysis Results of the Spinal Moiré System Data.
Based on DIERS parameters (such as scoliosis severity, rotation angle, and pelvic imbalance type) and the prediction model results, hierarchical rehabilitation programs are formulated:
Mild cases (Cobb angle: 10°-25°): Modified Spinal Balance Exercises based on the German Schroth Method plus biofeedback training (correcting poor posture through visual/auditory feedback).
Moderate cases (Cobb angle: 25°-45°): Brace wearing (adjusting brace stress points based on DIERS parameters) plus personalized exercise prescriptions (e.g., core muscle training targeting pelvic rotation).
Verification of Intervention Effectiveness Recruit 500 adolescent idiopathic scoliosis (AIS) patients as volunteers, and divide them into the precision intervention group and the conventional program group according to Lenke classification for a 1-year intervention. Evaluate changes in spine-pelvis parameters via the DIERS system every 3 months. The control group adopts conventional intervention programs (e.g., universal exercise therapy). Compare the two groups in terms of Cobb angle progression rate (proportion of patients with a progression ≥ 5° after intervention), improvement degree of pelvic compensation, and patient compliance.
Part 4: Formulation of Standardized Procedures and Pilot Promotion Procedure Integration Based on the results of screening, diagnosis, intervention, and management, a standardized procedure is formed as follows: Initial Screening (Modified Five-Step Method) → Re-examination (DIERS System) → Diagnosis (Combined with Cobb Angle and Lenke Classification) → Personalized Intervention (Guided by DIERS Parameters) → Regular Follow-up (DIERS Monitoring).
Pilot Promotion Pilot the procedure in 3-5 primary and secondary schools and 2-3 primary medical institutions in Nantong City, and evaluate the screening coverage rate (target: ≥ 80%), re-examination rate of patients with abnormal results (target: ≥ 60%), and intervention effective rate (target: ≥ 60%).
Collect feedback from the pilot sites and optimize procedural details (e.g., simplifying the operation steps of the DIERS system and adding a parental education module).
VII. Data Statistics and Outcome Dissemination Statistical analysis is performed using SPSS 26.0 or R software. Measurement data are expressed as mean ± standard deviation; inter-group comparisons are conducted using t-test or analysis of variance (ANOVA). Enumeration data are analyzed using the chi-square test. A value of P < 0.05 is considered statistically significant.
Compile research reports, 1-2 SCI-indexed papers, and the Guidelines for Screening and Intervention of Adolescent Scoliosis in Nantong City, and promote the popularization of research outcomes among regional medical institutions and schools.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
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 |
|---|---|---|
| Mild cases | Cobb angle: 10°-25° | |
| Moderate cases | Cobb angle: 25°-45° |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Compare the Cobb angles measured by the DIERS 4D System in two positions (arms hanging naturally and elbows bent with hands on shoulders) with those measured by X-ray, respectively.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
- Investigators
- Guanhua Xu, Dr., Study director, Nantong First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899294
- Sponsor's protocol ID
- ChunyanJI
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
- ClinicalTrials.gov ID
- NCT07899294
- Acronym / sponsor ID
- ChunyanJI
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jiawei JiangUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Taking the DIERS Spinal Moiré System as the primary tool, this study intends to establish an early warning model for adolescent scoliosis based on the system, verify the quantitative relationship between different body postures, three-dimensional pelvic parameters (inclination, rotation angle, torsion angle) and Cobb angle progression, analyze the pelvic compensation characteristics of different Lenke classifications, establish a biomechanical prediction model, develop a dynamic risk assessment algorithm suitable for campus screening, formulate personalized rehabilitation programs under the guidance of DIERS parameters, evaluate the inhibitory effect of biofeedback training on scoliosis progression, and form a standardized "screening-diagnosis-intervention-management" process.
This project will develop and promote a screening and precision intervention system for adolescent scoliosis based on the DIERS Spinal Moiré System. The research outcomes of this project will assist the clinical diagnosis and treatment of adolescent idiopathic scoliosis, and propose a precision diagnosis and treatment strategy led by a quantitative data platform. The research findings of the project will be mainly submitted in the form of papers, with the plan to publish 1-2 papers indexed in SCI.
Detailed description
Against the backdrop of the Healthy China Strategy, the state attaches great importance to the health of adolescents and children. The "Healthy China 2030" Planning Outline puts forward the concept of "shifting the health threshold forward", identifying adolescents as a key population for prevention and control. On February 1, 2021, the Ministry of Education of China explicitly issued a document stating that scoliosis prevention should be incorporated into school health education and the monitoring network for common student diseases. In the same year, the National Health Commission released the Technical Guidelines for the Prevention and Control of Spinal Deformities in Children and Adolescents, which provides a reference framework for the prevention and control of spinal health in this population.
In this context, establishing a scientific and comprehensive policy for the screening and monitoring of adolescent scoliosis is of great practical significance for the early detection, early intervention and early treatment of scoliosis, as well as for safeguarding the spinal health of adolescents and children. However, domestically, only Shenzhen incorporated spinal screening into the compulsory education physical examination items in 2022, adopting the "five-step method" (including the use of a trunk rotation meter) for testing. In contrast, clinical palpation methods (such as the Adam's Forward Bend Test) have a specificity of only 60-70%, and traditional X-ray examinations are still widely used for subsequent rechecks.
Main Research Content Part 1: Establish a Comprehensive Scoliosis Screening Process Set up a research team and clarify the division of responsibilities among members. The Municipal Health Commission and Education Bureau shall demarcate the screening jurisdictions for each hospital; the Department of Spinal Surgery of the Municipal First People's Hospital shall take the lead in organizing training on on-site screening and monitoring for all participating hospitals, and formulate screening and monitoring procedures. The Municipal Education Bureau shall determine the number of subjects to be screened and specify the screening schedule. All hospitals shall collaborate with schools to organize screening for eligible adolescents and children. For children with abnormal results in the initial screening, it is recommended that they undergo an examination using the DIERS Spinal Moiré System.
Part 2: Analyze the Data from the Spinal Moiré System and Establish a Specialized Database for Adolescent Scoliosis For patients with abnormal results in the initial screening, it is recommended that they undergo a re-examination using the DIERS 4D Spinal Moiré System at Nantong First People's Hospital. All patients shall complete two sets of full-spine examinations with the DIERS 4D System in different positions: the standing position with arms hanging naturally and the standing position with elbows bent and hands on shoulders, in addition to a 4D motion examination. The DIERS 4D measurements shall be conducted independently by two physicians, with the average value taken as the final result. The operation of the DIERS 4D System shall be performed by professionally trained technicians, and the system will automatically generate the measured Cobb angle values and spine-pelvis related parameters. All collected data shall be deployed on a cloud computing server.
For the clinical data of all patients with adolescent idiopathic scoliosis (AIS), changes in the Cobb angle, vertebral rotation angle, pelvic parameters (pelvic torsion, pelvic rotation, pelvic inclination) and coronal plane balance measured by the DIERS 4D System in the two positions (arms hanging naturally vs. elbows bent and hands on shoulders) shall be observed, so as to analyze the impact of measurement position differences on the spine-pelvis morphological parameters. Pearson correlation analysis, Logistic regression and Wilcoxon test shall be adopted to evaluate parameter differences and high-risk factors.
Construction of the Prediction Model: Taking Cobb angle progression (an increase of ≥ 5° within 6 months) as the outcome indicator, variables including pelvic parameters, body posture difference parameters, age and bone age shall be incorporated. A biomechanical prediction model shall be established using multivariate regression analysis or machine learning algorithms (e.g., random forest). The model performance (e.g., AUC value, accuracy rate) shall be evaluated through internal validation (20% of the samples shall be selected for testing) and external validation (comparison with AIS data from other regions).
Part 3: Develop Personalized Treatment Plans for Adolescent Scoliosis Based on the Analysis Results of the Spinal Moiré System Data.
Based on DIERS parameters (such as scoliosis severity, rotation angle, and pelvic imbalance type) and the prediction model results, hierarchical rehabilitation programs are formulated:
Mild cases (Cobb angle: 10°-25°): Modified Spinal Balance Exercises based on the German Schroth Method plus biofeedback training (correcting poor posture through visual/auditory feedback).
Moderate cases (Cobb angle: 25°-45°): Brace wearing (adjusting brace stress points based on DIERS parameters) plus personalized exercise prescriptions (e.g., core muscle training targeting pelvic rotation).
Verification of Intervention Effectiveness Recruit 500 adolescent idiopathic scoliosis (AIS) patients as volunteers, and divide them into the precision intervention group and the conventional program group according to Lenke classification for a 1-year intervention. Evaluate changes in spine-pelvis parameters via the DIERS system every 3 months. The control group adopts conventional intervention programs (e.g., universal exercise therapy). Compare the two groups in terms of Cobb angle progression rate (proportion of patients with a progression ≥ 5° after intervention), improvement degree of pelvic compensation, and patient compliance.
Part 4: Formulation of Standardized Procedures and Pilot Promotion Procedure Integration Based on the results of screening, diagnosis, intervention, and management, a standardized procedure is formed as follows: Initial Screening (Modified Five-Step Method) → Re-examination (DIERS System) → Diagnosis (Combined with Cobb Angle and Lenke Classification) → Personalized Intervention (Guided by DIERS Parameters) → Regular Follow-up (DIERS Monitoring).
Pilot Promotion Pilot the procedure in 3-5 primary and secondary schools and 2-3 primary medical institutions in Nantong City, and evaluate the screening coverage rate (target: ≥ 80%), re-examination rate of patients with abnormal results (target: ≥ 60%), and intervention effective rate (target: ≥ 60%).
Collect feedback from the pilot sites and optimize procedural details (e.g., simplifying the operation steps of the DIERS system and adding a parental education module).
VII. Data Statistics and Outcome Dissemination Statistical analysis is performed using SPSS 26.0 or R software. Measurement data are expressed as mean ± standard deviation; inter-group comparisons are conducted using t-test or analysis of variance (ANOVA). Enumeration data are analyzed using the chi-square test. A value of P < 0.05 is considered statistically significant.
Compile research reports, 1-2 SCI-indexed papers, and the Guidelines for Screening and Intervention of Adolescent Scoliosis in Nantong City, and promote the popularization of research outcomes among regional medical institutions and schools.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild cases | – | –Cobb angle: 10°-25° |
| Moderate cases | – | –Cobb angle: 25°-45° |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent patients with abnormal initial screening results from October 2025 to October 2027 will be selected for health education and advised to undergo further examinations in our hospital, followed by screening of those with abnormal results detected by the Spinal Moiré System.
Key inclusion criteria (1 listed)
- The volunteers recruited shall meet the diagnostic criteria for adolescent idiopathic scoliosis (AIS), with Lenke classification type 1 or 5 and a Cobb angle ranging from 10° to 45°.
Key exclusion criteria (1 listed)
- Patients with concurrent other spinal diseases, a history of previous spinal surgery, or non-idiopathic 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
Cobb angle
Time frame: through study completion, an average of 2 year
Compare the Cobb angles measured by the DIERS 4D System in two positions (arms hanging naturally and elbows bent with hands on shoulders) with those measured by X-ray, respectively.
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Guanhua Xu, Dr. study director
Nantong First People's Hospital
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 Adolescent Idiopathic Scoliosis (AIS), run by Jiawei Jiang 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: through study completion, an average of 2 year). 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 27 Oct 2026.