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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Patients diagnosed with AIS;② Sex is not limited, age 10-18 years old; ③ Those who sign the informed consent and can cooperate with follow-up visits; ④ Those who can cooperate with X-ray, chemical test, genetic test and other examination and evaluation for the measurement of relevant indexes.

Disqualifiers

Subjects with spine-related diseases such as Marfan's syndrome;

Subjects with previous ankylosing spondylitis, spinal neurofibroma, spinal tuberculosis, spinal trauma and other spine-related diseases;

Subjects with combined serious medical diseases and psychiatric patients;

Those with ECOG score > 2, which may have an impact on the study results;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low risk experimental group

    Behavioral

    Guiding + Manipulation + Traditional Chinese Medicine

  • Medium risk experimental group

    Behavioral

    Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces

  • High risk experimental group

    Genetic

    Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation

  • Control group COBB 10-20°

    Behavioral

    Specific Exercise Therapy

  • Control group COBB 20-45°

    Behavioral

    Orthopedic Braces + Specific Exercise Therapy

  • Control group COBB >45°

    Behavioral

    Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery

  • Experimental group (AIS group)

    Other intervention

    Molecular marker exploration and validation

  • Control group (healthy control)

    Other intervention

    Molecular marker exploration and validation

  • Controlled follow-up before and after AIS

    Other intervention

    Construction and validation of AIS risk prediction model completed

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: according to the order of their visits then were assigned numbersExperimental treatment 9 interventions
Group B: According to the order of their visits to the clinic, given the appropriate number,Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Cobb Angle

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.

Time frame
Pre-treatment, 3, 6, 9, 12 months post-treatment
2

Trunk Rotation Degree -Angle of Trunk Rotation

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.

Time frame
Pre-treatment, 3, 6, 9, 12 months post-treatment
3

Coronal Balance

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.

Time frame
Pre-treatment, 3, 6, 9, 12 months post-treatment
4

Sagittal Balance

Sagittal Balanced descriptions in the sagittal plane are an important way to assess scoliosis and its impact on body structure and function.

Time frame
Pre-treatment, 3, 6, 9, 12 months post-treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: