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NCT Number: NCT05466383

Screening and Intervention for AIS 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.

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Key information

Conditions

AIS

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital

Haikou, Hainan, 570300, China

Location status: Recruiting

Location contact

Chaoyin Jiang, MD

CONTACT

Chaoyin Jiang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Exercise rehabilitation with Schroth method

Brace

Device

Wear an orthopedic brace

Primary outcomes

  1. 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

  1. Change in SRS-22 score from baseline over time

    Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment

    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

  2. Change in vital capacity from baseline over time

    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 at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment.

  3. Change in plantar pressure from baseline over time

    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 at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months after treatment compared with those before treatment.

  4. Change in gait from baseline over time

    Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment

    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

  5. Correlation between the treatment compliance and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment

  6. Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the skeletal maturity (Risser's sign) at baseline and the out-of-control rate of treatment

  7. Correlation between the Cobb's angle 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

  8. Correlation between the immediate correction and the out-of-control rate of treatment

    Time frame: 36 months

    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

  9. The incidence of adverse events

    Time frame: 36 months

    The incidence of adverse events for the intervention

  10. The change in Cobb angle from baseline over time

    Time frame: 36 months

    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

  11. Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline

  12. Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline

  13. Correlation between the immediate correction and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    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

  14. Correlation between the Cobb's angle at baseline 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

Other outcomes

  1. Correlation between the age and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the patient's age and the out-of-control rate of treatment

  2. Correlation between the BMI at baseline and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the patient's BMI (kg/m^2) at baseline and the out-of-control rate of treatment

  3. Correlation between the type of AIS and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the type of AIS and the out-of-control rate of treatment

  4. Correlation between the types of braces and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the types of braces and the out-of-control rate of treatment

  5. Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the average time (hours) spent doing homework per day at baseline and the out-of-control rate of treatment

  6. Correlation between the vitamin D content at baseline and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the serum 25(OH)D (nmol/L) at baseline and the out-of-control rate of treatment

  7. Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment

    Time frame: 36 months

    Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment

  8. Correlation between the age and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the patient's age and the change in 36-month Cobb angle from baseline

  9. Correlation between the BMI at baseline and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the patient's BMI (kg/m^2) at baseline and the change in 36-month Cobb angle from baseline

  10. Correlation between the type of AIS and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the type of AIS and the change in 36-month Cobb angle from baseline

  11. Correlation between the types of braces and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the types of braces and the change in 36-month Cobb angle from baseline

  12. Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the average time (hours) spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline

  13. Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline

    Time frame: 36 months

    Correlation between the serum 25(OH)D (nmol/L) at baseline and the change in 36-month Cobb angle from baseline

  14. 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

    Time frame: 36 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Chaoyin Jiang, MD

CONTACT

[email protected]

+8689868603821

Zhenyu Wang, Ph.D

CONTACT

[email protected]

+8613391281688

Sponsors and collaborators

Lead sponsor

Chaoyin Jiang

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2022
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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