Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- Out-of-control rate of treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •9 years ≤ age ≤ 16 years
- •Diagnosis of AIS
- •10°≤Cobb's angle<45°
- •Signed informed consent form
Exclusion Criteria
- •With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders
- •Obvious deformity of lower limbs and(or) feet
- •Previous or ongoing treatment of AIS
- •Difficulty to read, understanding, and complete the study questionnaires
- •Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
Arms & Interventions
recommend exercise - perference brace
Intervention: Brace (Device)
recommend exercise - perference observation
recommend brace - perference brace
Intervention: Brace (Device)
recommend brace - perference exercise
Intervention: Exercise (Behavioral)
recommend brace - perference observation
recommend exercise - perference exercise
Intervention: Exercise (Behavioral)
Outcomes
Primary Outcomes
Out-of-control rate of treatment
Time Frame: 36 months
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).
Secondary Outcomes
- Correlation between the treatment compliance and the out-of-control rate of treatment(36 months)
- Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment(36 months)
- Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline(36 months)
- Change in SRS-22 score from baseline over time(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(at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment)
- Change in gait from baseline over time(at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment)
- Correlation between the immediate correction and the out-of-control rate of treatment(36 months)
- Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline(36 months)
- Correlation between the immediate correction and the change in 36-month Cobb angle from baseline(36 months)
- Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline(36 months)
- Change in vital capacity from baseline over time(at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment)
- Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment(36 months)
- The change in Cobb angle from baseline over time(36 months)
- The incidence of adverse events(36 months)
Investigators
Chaoyin Jiang
Professor
Shanghai 6th People's Hospital