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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,000
Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital
Haikou, Hainan, China
RECRUITINGOut-of-control rate of treatment
Among the patients with skeletal immaturity (Risser's sign 0, 1, 2), out-of-control rate of treatment at the follow-up to 36 months or at skeletal maturity during the trial (i.e., 4° for female Risser's sign or 5° for male Risser's sign). Out-of-control rate of treatment is defined as either: Cobb angle progression \>5°, or Cobb angle ≥45°, or the physician recommends or already has enhanced the intervention regimen (i.e., no intervention change to exercise intervention, no intervention change to brace intervention, or exercise intervention change to brace intervention).
Time frame: 36 months
Change in SRS-22 score from baseline over time
Change in quality of life (SRS-22 score) from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in vital capacity from baseline over time
Change in vital capacity from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment.
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in plantar pressure from baseline over time
Change in plantar pressure from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months after treatment compared with those before treatment.
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in gait from baseline over time
Change in gait from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
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Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Correlation between the treatment compliance and the out-of-control rate of treatment
Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment
Time frame: 36 months
Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment
Correlation between the skeletal maturity (Risser's sign) at baseline and the out-of-control rate of treatment
Time frame: 36 months
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
Time frame: 36 months
Correlation between the immediate correction and the out-of-control rate of treatment
Correlation between the immediate correction \[(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle\] and the out-of-control rate of treatment
Time frame: 36 months
The incidence of adverse events
The incidence of adverse events for the intervention
Time frame: 36 months
The change in Cobb angle from baseline over time
The change in Cobb angle from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
Time frame: 36 months
Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline
Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline
Time frame: 36 months
Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline
Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline
Time frame: 36 months
Correlation between the immediate correction and the change in 36-month Cobb angle from baseline
Correlation between the immediate correction \[(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle\] and the change in 36-month Cobb angle from baseline
Time frame: 36 months
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
Time frame: 36 months