Screening and treating adolescents with adolescent idiopathic scoliosis in Haikou, China
Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China
This study is testing non-surgical treatments like exercise and braces for kids with mild to moderate scoliosis to see how well they work over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 9 Years to 16 Years |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 1 site (Haikou, Hainan) |
| Trial ID | NCT05466383 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to recruit mild to moderate adolescent idiopathic scoliosis (AIS) patients from a large population of primary and secondary school students in Haikou, Hainan Province. Participants aged 9 to 16 years will receive non-surgical interventions, such as exercise or brace treatment, based on physician recommendations and patient preferences. The study will follow these patients for 36 months to assess the effectiveness and safety of the interventions in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 9 to 16 years diagnosed with mild to moderate AIS.
Not a fit: Patients with other developmental, musculoskeletal, or mental disorders, or those who have previously received treatment for AIS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-surgical treatment options for adolescents with AIS, potentially improving their quality of life.
How similar studies have performed: While similar non-surgical interventions for AIS have been explored, this specific approach in a large screening population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 9 years ≤ age ≤ 16 years 2. Diagnosis of AIS 3. 10°≤Cobb's angle\<45° 4. Signed informed consent form Exclusion Criteria: 1. With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders 2. Obvious deformity of lower limbs and(or) feet 3. Previous or ongoing treatment of AIS 4. Difficulty to read, understanding, and complete the study questionnaires 5. Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
Where this trial is running
Haikou, Hainan
- Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital — Haikou, Hainan, China (Recruiting)
Study contacts
- Study coordinator: Chaoyin Jiang, MD
- Email: Jiangdoctor1979@sina.com
- Phone: +8689868603821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.