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NCT Number: NCT06506227

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prokin balance apparatus

Hangzhou, Zhejiang, 310006, China

Location contact

Jingying Liang, master candidate

CONTACT

About this study

Currently, there are problems of high genetic and phenotypic heterogeneity in AIS research, lack of in-depth epigenetic studies, and lack of clarity in pathogenic mechanisms. This project proposes to use EWAS technology, combined with a hybrid model of multidimensional and multimodal data fusion, to realize a multi-omics joint analysis, to clarify the amount of synergistic effects between multi-omics risk factors and AIS, to draw a map of modifiable risk factors, to clarify AIS biomarkers, and to reveal AIS To clarify the biomarkers of AIS and reveal the pathogenic mechanism of AIS. Currently, the clinical diagnosis and treatment of AIS is highly subjective and lacks objective and accurate risk prediction, which makes it easy to make wrong clinical decisions, resulting in insufficient, delayed or excessive treatment, missing the optimal time for treatment, and poor clinical efficacy. This project intends to establish a multi-dimensional and multi-modal dynamic database, use the unified model construction technology, combined with the sample imbalance model, to construct a unified and accurate prediction model for AIS, to perform clinical typing and risk stratification for AIS, to establish individualized and accurate diagnostic and treatment protocols for AIS, to improve the efficacy of AIS, to obtain high-quality clinical evidence, and to formulate industry-recognized clinical prevention and treatment standards, norms, and guidelines. Through mining AIS biomarkers, elucidating new mechanisms of AIS pathogenicity, constructing risk prediction models, optimizing AIS precision diagnosis and treatment techniques, and formulating precise diagnosis and treatment protocols and technical specifications for AIS combining Chinese and Western medicine with independent intellectual property rights, the project will achieve full coverage of Zhejiang Province by the end of 2026, forming the "Zhejiang experience" in AIS diagnosis and treatment. Zhejiang experience" will be formed in AIS diagnosis and treatment. The promotion of the results can realize the precision of AIS diagnosis and treatment, improve the efficacy of AIS treatment, reduce the incidence of severe scoliosis, reduce medical expenditure by billions of dollars, and alleviate the economic burden on families and society.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Those who are affected by external factors such as economy, individualized differences, etc., so that they cannot complete the study.

Treatment and study plan

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

Molecular marker exploration and validation

Control group (healthy control)

Other

Molecular marker exploration and validation

Controlled follow-up before and after AIS

Other

Construction and validation of AIS risk prediction model completed

Primary outcomes

  1. Cobb Angle

    Time frame: 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.

  2. Trunk Rotation Degree -Angle of Trunk Rotation

    Time frame: 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.

  3. Coronal Balance

    Time frame: 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.

  4. Sagittal Balance

    Time frame: 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.

  5. Frontal Convexity Of the Spine Angle

    Time frame: 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.

  6. Offside Convexity Of the Spine Angle

    Time frame: 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.

  7. Electromyographic (AEMG) indicators

    Time frame: 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.)

  8. Electroencephalographic (EEG) Index

    Time frame: 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.

  9. Postural Posture Assessment

    Time frame: 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.

  10. Balance Function

    Time frame: 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.

  11. Questionnaire on Spinal Health of Children and Adolescents

    Time frame: 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.

  12. Skeletal maturity (Risser's sign)

    Time frame: 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.

  13. Types of scoliosis

    Time frame: 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.

  14. Sagittal plane axial distance (SVA)

    Time frame: 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.

  15. Muscle and bone ultrasound

    Time frame: 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.

  16. Number of participants with Chemical testing

    Time frame: 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.

  17. Number of participants with Blood samples

    Time frame: 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.

  18. Urine test

    Time frame: 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.

Study contacts

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

Honggen Du, bachelor

CONTACT

[email protected]

13958088996

Jiang Zhong, bachelor

CONTACT

[email protected]

13588887567

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

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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