Early screening and warning research on adolescent idiopathic scoliosis in China
| ISRCTN | ISRCTN13436876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13436876 |
| Sponsor | Ministry of Science and Technology of the People's Republic of China |
| Funder | Ministry of Science and Technology of the People's Republic of China |
- Submission date
- 19/12/2025
- Registration date
- 19/12/2025
- Last edited
- 19/12/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Adolescent Idiopathic Scoliosis (AIS) is a condition where the spine curves abnormally during adolescence. It affects many young people worldwide and can lead to serious disability if not treated early. Unfortunately, it is often missed in the early stages. This study aims to create a large group (called a cohort) of young people with and without AIS to better understand the condition. Researchers will collect detailed information, including medical tests, imaging, and blood samples, and use this data to build an early warning system. This system will combine traditional Chinese medicine and Western medicine approaches to help doctors diagnose and treat AIS earlier and more effectively.
Who can participate?
Young people aged 10 to 18 years who have AIS or do not have AIS can take part. There is no restriction on whether they are male or female.
What does the study involve?
This is an observational study, which means participants will not receive experimental treatment. Instead, researchers will monitor participants over time and collect information through tests, questionnaires, and follow-up visits.
What are the possible benefits and risks of participating?
Benefits include free physical exams, free assessments of back muscles, health education, and regular follow-up for 12 months. Risks and inconveniences include the time needed for hospital visits and tests, and the possibility that the condition may worsen during the study. If any problems occur, researchers will provide appropriate medical care. If the condition gets worse quickly, treatment will be offered.
Where is the study run from?
The study is being carried out at several hospitals in China, including Wangjing Hospital of the China Academy of Chinese Medical Sciences, Hebei Provincial Hospital of Traditional Chinese Medicine, and the Affiliated Hospital of Neck, Shoulder, Waist and Leg Pain of Shandong First Medical University.
When is the study starting and how long is it expected to run for?
The first participant will join around January 15, 2026. The last participant will join by June 1, 2028, and the study will finish on October 31, 2028.
Who is funding the study?
The study is funded by the National Key Research and Development Program of China (Grant No.: 2024YFC3507405).
Who is the main contact?
Feng Tianxiao (email: fengtianxiao96@163.com)
Contact information
Public
Wangjing Hospital of China Academy of Chinese Medical Sciences, No. 6 Wangjing Zhonghuan South Road, Chaoyang District
Beijing
100102
China
| Phone | +86 10-84739194 |
|---|---|
| wangxu_209@163.com |
Scientific
Wangjing Hospital of China Academy of Chinese Medical Sciences, No. 6 Wangjing Zhonghuan South Road, Chaoyang District
Beijing
100102
China
| Phone | +86 10-84739194 |
|---|---|
| fengtianxiao96@163.com |
Principal investigator
Wangjing Hospital of China Academy of Chinese Medical Sciences, No. 6 Wangjing Zhonghuan South Road, Chaoyang District, Beijing
Beijing
100102
China
| Phone | 010-84739194 |
|---|---|
| weixu.007@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Multicenter screening and disease-syndrome combined early warning research on adolescent idiopathic scoliosis in China |
| Study acronym | AIS-ESW |
| Study objectives | Adolescent Idiopathic Scoliosis (AIS) is a major cause of disability among adolescents worldwide, characterized by high incidence, high progression rate, high disability rate, low awareness rate, and low early diagnosis rate, imposing a heavy socioeconomic burden. Early identification of high-risk groups and patients, risk early warning, precise management, and efficient treatment are key clinical issues urgently needing resolution for this disease. However, there is currently a lack of supporting disease-specific cohorts and early warning systems to meet the significant needs of clinical diagnosis, treatment, and scientific research for AIS. Guided by clinical problems, this study will recruit eligible "diseased" and "un-diseased" AIS subjects from multiple clinical institutions to establish a population cohort. A comprehensive set of macro, meso, and micro indicators will be systematically collected from subjects, including clinical characteristics, patient-reported outcome measures, TCM four diagnostic methods, TCM syndromes, TCM constitutions, imaging data, biomechanical parameters, and blood samples. Following internationally recognized methods and procedures for predictive model construction, a syndrome-disease combined early warning system integrating traditional Chinese and Western medicine multimodal information will be established. This system aims to support the screening, diagnosis, treatment, and scientific research of AIS, and contribute to the implementation and advancement of the Healthy China Strategy. |
| Ethics approval(s) |
Approved 29/10/2025, Medical Ethics Committee of Wangjing Hospital of China Academy of Chinese Medical Sciences (Wangjing Hospital of China Academy of Chinese Medical Sciences, No. 6 Wangjing Zhonghuan South Road, Chaoyang District, Beijing, 100102, China; +86 10-84739681; 2454142594@qq.com), ref: WJEC-KT-2025-055-P001 |
| Health condition(s) or problem(s) studied | Early screening and warning on adolescent idiopathic scoliosis |
| Intervention | This is a multicenter observational cohort study conducted under the National Key R&D Program of China (Grant No.: 2024YFC3507405), led by Wangjing Hospital of China Academy of Chinese Medical Sciences. A total of 2000 adolescents aged 10–18 years will be recruited from scoliosis-specialized outpatient clinics of participating centers, including those with Adolescent Idiopathic Scoliosis (AIS, "diseased" group) and individuals at risk of developing AIS ("un-diseased" group). All participants or their legal guardians will provide written informed consent prior to study enrollment. Data collection will be conducted at three time points: baseline, 6 months, and 12 months after enrollment. A comprehensive set of indicators will be systematically collected, covering three levels: macro indicators (demographic data, lifestyle factors, physical examinations, patient-reported outcomes, and Traditional Chinese Medicine-related information including four diagnostic methods, syndromes, and constitution), meso indicators (standing full-spine X-ray assessments and paraspinal muscle function evaluations via surface electromyography), and micro indicators (serum samples for transcriptomic, metabolomic, and proteomic analyqses to identify potential biomarkers). Following data preprocessing (structuring, standardization, and feature selection), multiple machine learning algorithms will be applied to construct a syndrome-disease combined early warning model integrating Traditional Chinese Medicine and Western medicine multimodal information, in accordance with the international TRIPOD statement. The model will be validated internally (using 30% of the dataset and 10-fold cross-validation) and externally (using data from one independent participating center), with performance evaluated by discrimination, calibration, and clinical utility. Strict quality control measures will be implemented throughout the study, including standardized training for researchers, regular calibration of detection equipment, periodic on-site monitoring by the leading center, quality control for laboratory tests, and targeted strategies to improve participant follow-up adherence. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/10/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2000 |
| Key inclusion criteria | Subjects with adolescent idiopathic scoliosis: 1. According to the diagnostic criteria of the Scoliosis Research Society (SRS), scoliosis is defined as a condition where the Cobb angle measured on a standing full-spine coronal X-ray film is ≥ 10°. 2. Aged 10–18 years. 3. Cobb angle between 10° and 45°, including mild scoliosis (10° ≤ Cobb angle < 20°) and moderate scoliosis (20° ≤ Cobb angle < 45°). 4. Risser sign grade 0–4. 5. Informed consent signed by the subject or their guardian. 6. No scoliosis-specific treatment received in the past 3 months. Healthy volunteers: 1. Cobb angle < 10°. 2. Aged 10–18 years. 3. Informed consent signed by the subject or their guardian. 4. No participation in other clinical studies in the past 3 months. |
| Key exclusion criteria | 1. Secondary scoliosis, such as congenital scoliosis and neuromuscular scoliosis. 2. Comorbidity with severe systemic diseases, including those of the cardiovascular, cerebrovascular, liver, and kidney systems. 3. Spinal lesions, such as fractures, tumors, and tuberculosis. 4. Mental illness or cognitive impairment that prevents cooperation with treatment and evaluation. |
| Date of first enrolment | 15/01/2026 |
| Date of final enrolment | 01/06/2028 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
19/12/2025: Trial's existence confirmed by Medical Ethics Committee of Wangjing Hospital of China Academy of Chinese Medical Sciences.
