Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of AIS Based on Epigene-phenotype

Condition(s) studied

Investigational drug(s) / intervention(s)

Low risk experimental group: Guiding + Manipulation + Traditional Chinese Medicine

Medium risk experimental group: Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces

High risk experimental group: Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation

Control group COBB 10-20°: Specific Exercise Therapy

Control group COBB 20-45°: Orthopedic Braces + Specific Exercise Therapy

Control group COBB >45°: Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery

Experimental group (AIS group): Molecular marker exploration and validation

Control group (healthy control): Molecular marker exploration and validation

Controlled follow-up before and after AIS: Construction and validation of AIS risk prediction model completed

Study summary

Mining AIS biomarkers, elucidating the new mechanism of AIS pathogenicity, constructing risk prediction models, optimizing AIS precise diagnosis and treatment techniques, formulating precise diagnosis and treatment protocols and technical specifications for AIS combined with Chinese and Western medicine with independent intellectual property rights, and realizing the full coverage of Zhejiang Province by the end of 2026, so as to form the "Zhejiang experience" of AIS diagnosis and treatment.

Eligibility

Primary outcome measure(s)

• Cobb Angle — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Cobb's angle is an angle used to measure the severity of scoliosis by measuring the angle of lateral curvature to assess the degree of scoliosis.
• Trunk Rotation Degree -Angle of Trunk Rotation — Pre-treatment, 3, 6, 9, 12 months post-treatment
  The patient stood with feet shoulder-width apart and bent forward with hands to palms, and the maximum degree of spinal razorback was measured with the Scoliometer Scoliosis Screening Scale.
• Coronal Balance — Pre-treatment, 3, 6, 9, 12 months post-treatment
  A plumb line is usually used to determine coronal plane balance. In the coronal plane of a normal spine, a plumb line leading from the center of the C7 vertebra will pass through the center of the sacrum or within 1 cm to the left and right of the S1 spinous process.
• Sagittal Balance — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Sagittal Balanced descriptions in the sagittal plane are an important way to assess scoliosis and its impact on body structure and function.
• Frontal Convexity Of the Spine Angle — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Your doctor will ask you to stand or sit down and then take x-ray pictures of your spine from the side. These pictures show the curve and curvature of the spine, from which the doctor can assess the condition of the lordosis.
• Offside Convexity Of the Spine Angle — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Your doctor will ask you to stand or sit down and then take x-ray pictures of your spine from the side. These pictures clearly show the curve and curvature of the spine, and the doctor can use these images to evaluate the condition of the kyphosis.
• Electromyographic (AEMG) indicators — Pre-treatment, 3, 6, 9, 12 months post-treatment
  The obtained surface EMG signal data were input into MegaWin 2.3 signal processing software to extract and analyze linear metrics (mean frequency, median frequency, muscle activity intensity, etc.), and nonlinear metrics (multi-scale sample entropy, fractal dimension, coherence, etc.)
• Electroencephalographic (EEG) Index — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Matlab based software and its toolkit EEGLAB were used to preprocess the data and get clean EEG signal. The effective number of channels acquired in this study was 18 leads. Fifteen 2s segments (i.e., 45s of data) were randomly selected for each subject to obtain δ (1-4Hz), θ (4-8Hz), α (8-13Hz), and β (13-30Hz), and the functional connectivity of the different bands was calculated separately.
• Postural Posture Assessment — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Measurements of trunk offset angle, pelvic tilt angle, thoracic lordosis angle, lumbar lordosis angle, the sum of the maximum angle of vertebral body left-right rotation, the sum of the maximum left-right deviation of the trunk, and the angle of primary bending and lateral curvature can be obtained after completion of the filming.
• Balance Function — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Subjects remained stationary with eyes open for 30 seconds, and four parameters of COP were recorded: area of COP oscillation, mean oscillation velocity in the anteroposterior (AP) and medial-lateral (ML) directions, and length of movement.
• Questionnaire on Spinal Health of Children and Adolescents — Pre-treatment, 3, 6, 9, 12 months post-treatment
  The Spine Health Questionnaire for Children and Adolescents is designed to understand and assess the spine health status and related behaviors of this age group in their daily lives.
• Skeletal maturity (Risser's sign) — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Doctors determine a child's bone age based on the closest standard x-ray image in the atlas to how the child's bones appear on the x-ray.
• Types of scoliosis — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Although scoliosis presents all lateral curvature and vertebral rotation in the spinal phase, we can categorize it into different types based on the number of degrees of scoliosis when the degree of scoliosis is greater than ten degrees in the online screen slice mountain.
• Sagittal plane axial distance (SVA) — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Sagittal plane axial distance (SVA) is one of the most important indicators of spinal and body postural balance, especially when assessing anterior-posterior spinal balance. It is usually measured by imaging (e.g., X-rays or MRI) and is used to quantify the anterior-posterior positional differences between the head and a pelvis.
• Muscle and bone ultrasound — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Morphological characteristics of the paravertebral muscles were extracted by ultrasonography of the morphology and elasticity of the paravertebral muscles of the enrolled patients.
• Number of participants with Chemical testing — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Subjects were obtained for routine blood, urine, biochemistry, thyroid function, sex hormones, allergens, growth hormone, leptin, estrogen, melatonin, and other tests.
• Number of participants with Blood samples — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Venous blood samples were collected from all included patients at 5 mL per person.The obtained blood samples were placed at -8°C. Samples were immediately separated, partitioned and stored after collection, and some blood samples were immediately sent to the hospital for biochemical indexes.
• Urine test — Pre-treatment, 3, 6, 9, 12 months post-treatment
  Drink little or no water before going to bed, and try to retain urine in the bladder for more than 4 hours, use a sterile wide-mouth container to collect, discard the anterior part of the urine, and retain about 10mL of the middle part of the urine into a sterile container, and send it to the test immediately.

Trial sites (1)

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