Clinical trial NCT05466383: Screening and Intervention for AIS in Haikou, Hainan Province, China
Official title: Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AIS
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. The patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. Patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.


Eligibility 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

Primary outcomes:
measure: Out-of-control rate of treatment
timeFrame: 36 months
Secondary outcomes:
measure: Change in SRS-22 score from baseline over time
timeFrame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
measure: Change in vital capacity from baseline over time
timeFrame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
measure: Change in plantar pressure from baseline over time
timeFrame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
measure: Change in gait from baseline over time
timeFrame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
measure: Correlation between the treatment compliance and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the immediate correction and the out-of-control rate of treatment
timeFrame: 36 months
measure: The incidence of adverse events
timeFrame: 36 months
measure: The change in Cobb angle from baseline over time
timeFrame: 36 months
measure: Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the immediate correction and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
Other outcomes:
measure: Correlation between the age and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the BMI at baseline and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the type of AIS and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the types of braces and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the vitamin D content at baseline and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment
timeFrame: 36 months
measure: Correlation between the age and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the BMI at baseline and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the type of AIS and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the types of braces and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
measure: Correlation between the average time spent doing outdoor exercise after school per day at baseline and the change in 36-month Cobb angle from baseline
timeFrame: 36 months
Locations:
city: Haikou
country: China
facility: Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital
state: Hainan
Study officials:
References: