Adolescent Idiopathic ScoliosisNCT06506227
Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of AIS Based on Epigene-phenotype
A study testing Low risk experimental group, Medium risk experimental group and High risk experimental group in people with Adolescent Idiopathic Scoliosis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Low risk experimental group, Medium risk experimental group and High risk experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Prokin balance apparatus
Hangzhou, Zhejiang, 310006
Jingying Liang, master candidate
About this study
Official title: Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of Adolescent Idiopathic Scoliosis 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.
Read the detailed description
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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Low risk experimental group, Medium risk experimental group, High risk experimental group, Control group COBB 10-20°, Control group COBB 20-45°
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low risk experimental groupBehavioural
Guiding + Manipulation + Traditional Chinese Medicine
Medium risk experimental groupBehavioural
Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces
High risk experimental groupGenetic
Guiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation
Control group COBB 10-20°Behavioural
Specific Exercise Therapy
Control group COBB 20-45°Behavioural
Orthopedic Braces + Specific Exercise Therapy
Control group COBB >45°Behavioural
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 AISOther
Construction and validation of AIS risk prediction model completed
| Study group | Role | What they receive |
|---|---|---|
| according to the order of their visits then were assigned numbers | Experimental | The patients were assigned numbers according to the order of their visits, and after obtaining informed consent, they were divided into a treatment group and a control group to conduct a prospective cohort study. Receives: Behavioral: Low risk experimental group; Behavioral: Medium risk experimental group; Genetic: High risk experimental group; Behavioral: Control group COBB 10-20°; Behavioral: Control group COBB 20-45°; Behavioral: Control group COBB >45°; Other: Experimental group (AIS group); Other: Control group (healthy control); Other: Controlled follow-up before and after AIS |
| According to the order of their visits to the clinic, given the appropriate number, | Experimental | According to the order of their visits to the clinic, given the appropriate number, divided into the test group and the control group, in strict accordance with the results of the group, the appropriate treatment and observation of the group, the teams of personnel and the implementation of clinical treatment should not be the same person. Receives: Behavioral: Low risk experimental group; Behavioral: Medium risk experimental group; Genetic: High risk experimental group; Behavioral: Control group COBB 10-20°; Behavioral: Control group COBB 20-45°; Behavioral: Control group COBB >45°; Other: Experimental group (AIS group); Other: Control group (healthy control); Other: Controlled follow-up before and after AIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Sagittal Balance
Sagittal Balanced descriptions in the sagittal plane are an important way to assess scoliosis and its impact on body structure and function.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Frontal Convexity Of the Spine Angle
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Offside Convexity Of the Spine Angle
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Electromyographic (AEMG) indicators
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.)
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Electroencephalographic (EEG) Index
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Postural Posture Assessment
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Balance Function
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Questionnaire on Spinal Health of Children and Adolescents
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Skeletal maturity (Risser's sign)
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Types of scoliosis
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Sagittal plane axial distance (SVA)
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Muscle and bone ultrasound
Morphological characteristics of the paravertebral muscles were extracted by ultrasonography of the morphology and elasticity of the paravertebral muscles of the enrolled patients.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Number of participants with Chemical testing
Subjects were obtained for routine blood, urine, biochemistry, thyroid function, sex hormones, allergens, growth hormone, leptin, estrogen, melatonin, and other tests.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Number of participants with Blood samples
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Urine test
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.
Measured: Pre-treatment, 3, 6, 9, 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Zhong, bachelor, Study director, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506227
- Sponsor's protocol ID
- 2024-KLS-039-02
- Status last verified
- May 2024
- First submitted
- 30 Jun 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of Adolescent Idiopathic Scoliosis Based on Epigene-phenotype
- ClinicalTrials.gov ID
- NCT06506227
- Acronym / sponsor ID
- 2024-KLS-039-02
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| according to the order of their visits then were assigned numbers | Experimental | Behavioral: Low risk experimental group, Behavioral: Medium risk experimental group, Genetic: High risk experimental group, Behavioral: Control group COBB 10-20°, Behavioral: Control group COBB 20-45°, Behavioral: Control group COBB >45°, Other: Experimental group (AIS group), Other: Control group (healthy control), Other: Controlled follow-up before and after AISThe patients were assigned numbers according to the order of their visits, and after obtaining informed consent, they were divided into a treatment group and a control group to conduct a prospective cohort study. |
| According to the order of their visits to the clinic, given the appropriate number, | Experimental | Behavioral: Low risk experimental group, Behavioral: Medium risk experimental group, Genetic: High risk experimental group, Behavioral: Control group COBB 10-20°, Behavioral: Control group COBB 20-45°, Behavioral: Control group COBB >45°, Other: Experimental group (AIS group), Other: Control group (healthy control), Other: Controlled follow-up before and after AISAccording to the order of their visits to the clinic, given the appropriate number, divided into the test group and the control group, in strict accordance with the results of the group, the appropriate treatment and observation of the group, the teams of personnel and the implementation of clinical treatment should not be the same person. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Subjects with spine-related diseases such as Marfan's syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low risk experimental groupGuiding + Manipulation + Traditional Chinese Medicine | Behavioural | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Medium risk experimental groupGuiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces | Behavioural | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| High risk experimental groupGuiding + Manipulation + Traditional Chinese Medicine + Specific Exercise Therapy + Orthopedic Braces + Specialized Inpatient Rehabilitation | Genetic | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Control group COBB 10-20°Specific Exercise Therapy | Behavioural | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Control group COBB 20-45°Orthopedic Braces + Specific Exercise Therapy | Behavioural | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Control group COBB >45°Orthopedic Braces + Specific Exercise Therapy + Recommended Surgery | Behavioural | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Experimental group (AIS group)Molecular marker exploration and validation | Other | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Control group (healthy control)Molecular marker exploration and validation | Other | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
| Controlled follow-up before and after AISConstruction and validation of AIS risk prediction model completed | Other | According to the order of their visits to the clinic, given the appropriate number,, according to the order of their visits then were assigned numbers |
Primary outcome
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.
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.
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.
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.
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.
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.
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.)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiang Zhong, bachelor study director
The First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low risk experimental group, Medium risk experimental group and High risk experimental group in people with Adolescent Idiopathic Scoliosis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Zhong, bachelor (13588887567, pjjzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb Angle (time frame: Pre-treatment, 3, 6, 9, 12 months post-treatment). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.