Screening and Intervention for AIS in Haikou, Hainan Province, China

Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China

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 Overview

• Status: Recruiting
• Conditions: AIS
• Intervention / Treatment: Behavioral: Exercise; Device: Brace

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chaoyin Jiang, MD; Phone Number: +8689868603821; Email: Jiangdoctor1979@sina.com
• Study Contact Backup: Name: Zhenyu Wang, Ph.D; Phone Number: +8613391281688; Email: drwang@vip.qq.com

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570300
      • Recruiting
      • Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital
      • Contact: Chaoyin Jiang, MD
      • Principal Investigator: Chaoyin Jiang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: recommend exercise - perference exercise	Behavioral: Exercise; Exercise rehabilitation with Schroth method
Active Comparator: recommend exercise - perference brace	Device: Brace; Wear an orthopedic brace
No Intervention: recommend exercise - perference observation
Active Comparator: recommend brace - perference brace	Device: Brace; Wear an orthopedic brace
Active Comparator: recommend brace - perference exercise	Behavioral: Exercise; Exercise rehabilitation with Schroth method
No Intervention: recommend brace - perference observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Out-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).	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events	The incidence of adverse events for the intervention	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	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.	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.	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	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	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	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	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	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	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	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	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	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	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the age and the out-of-control rate of treatment	Correlation between the patient's age and the out-of-control rate of treatment	36 months
Correlation between the BMI at baseline and the out-of-control rate of treatment	Correlation between the patient's BMI (kg/m^2) at baseline and the out-of-control rate of treatment	36 months
Correlation between the type of AIS and the out-of-control rate of treatment	Correlation between the type of AIS and the out-of-control rate of treatment	36 months
Correlation between the types of braces and the out-of-control rate of treatment	Correlation between the types of braces and the out-of-control rate of treatment	36 months
Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment	Correlation between the average time (hours) spent doing homework per day at baseline and the out-of-control rate of treatment	36 months
Correlation between the vitamin D content at baseline and the out-of-control rate of treatment	Correlation between the serum 25(OH)D (nmol/L) at baseline and the out-of-control rate of treatment	36 months
Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment	Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment	36 months
Correlation between the age and the change in 36-month Cobb angle from baseline	Correlation between the patient's age and the change in 36-month Cobb angle from baseline	36 months
Correlation between the BMI at baseline and the change in 36-month Cobb angle from baseline	Correlation between the patient's BMI (kg/m^2) at baseline and the change in 36-month Cobb angle from baseline	36 months
Correlation between the type of AIS and the change in 36-month Cobb angle from baseline	Correlation between the type of AIS and the change in 36-month Cobb angle from baseline	36 months
Correlation between the types of braces and the change in 36-month Cobb angle from baseline	Correlation between the types of braces and the change in 36-month Cobb angle from baseline	36 months
Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline	Correlation between the average time (hours) spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline	36 months
Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline	Correlation between the serum 25(OH)D (nmol/L) at baseline and the change in 36-month Cobb angle from baseline	36 months
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	Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the change in 36-month Cobb angle from baseline	36 months

Collaborators and Investigators

• Sponsor: Chaoyin Jiang

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GTYN2022001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No