Scoliosis Idiopathic AdolescentNCT06802653
Investigation on the Prevalence and Etiology of Adolescent Idiopathic Scoliosis in Nanchang Region
An observational study of Scoliosis Idiopathic Adolescent, run by Nanchang University Affiliated Rehabilitation Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the prevalence and etiology of adolescent idiopathic scoliosis in the Nanchang region. Elementary and middle school students who met the inclusion criteria were included in the study and school-based scoliosis screening was conducted. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic Adolescent
- What is being tested?
- not provided
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 28 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: adolescents aged 9 to 14 years in primary and secondary schools
Who may be able to join
- Age 9-14 years old, enrolled in elementary or middle school.
- Local residents of Nanchang, excluding students from special schools for children with physical or intellectual disabilities.
- No underlying medical conditions, and able to complete all examinations without difficulty.
- Willing to participate in the screening and having signed an informed consent form.
Who cannot join
- Severe Medical Conditions: Individuals with severe diseases of the heart, liver, kidneys, endocrine system, or hematopoietic system.
- Neurological or Psychiatric History: Individuals with a history of neurological or psychiatric disorders.
- Refusal to Participate: Individuals who are unwilling or refuse to participate in the screening.
- Severe Osteoporosis: Individuals diagnosed with severe osteoporosis.
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
Nanchang University Affiliated Rehabilitation Hospital
Nanchang, Jiangxi, 330003
About this study
The purpose of this study is to investigate the prevalence and etiology of adolescent idiopathic scoliosis in the Nanchang region. Elementary and middle school students who met the inclusion criteria were included in the study and school-based scoliosis screening was conducted. Diagnosis of suspected scoliosis was determined by physical examination, Adams forward bend test, measurement of trunk rotation angle, and Standing Anteroposterior X-ray of the Spine. The prevalence of suspected scoliosis among elementary and middle school students was calculated. At the same time, the researchers kept detailed records of all costs incurred in the school screening.
Read the detailed description
Scoliosis is a three-dimensional structural deformity of the spine that includes lateral curvature of the spine in the coronal plane, rotation in the horizontal plane, and alteration of the physiologic curvature in the sagittal plane. Scoliosis has an insidious onset and is often overlooked as there are no obvious symptoms in the early stages. As the disease progresses, it may lead to physical deformities, low back pain, decreased cardiorespiratory function, and may also cause psychological problems such as anxiety and depression. According to statistics, the global prevalence of scoliosis is 2-3%, and adolescent scoliosis is the most common type of scoliosis. The prevalence of scoliosis in adolescent females is higher than that of males. In recent years, the incidence of scoliosis has been on the rise as primary and secondary school students experience increased academic pressure and reduced physical activity and sleep time, which has caused great concern in society.
Scoliosis is thought to be associated with a variety of risk factors, including low BMI, gender differences, racial differences, asymmetrical backpack carrying, low physical activity, and prolonged screen viewing. However, despite the identification of many factors contributing to scoliosis, the comprehensive pathogenesis and natural progression of scoliosis are unknown.
Delaware pioneered school-based scoliosis screening in the 1960s, and it has since gradually spread throughout the United States, Canada, and Europe. Most studies have shown that early scoliosis screening is an effective way to prevent the progression of scoliosis in adolescents and reduce surgery rates. However, the implementation of mandatory scoliosis screening is controversial. Opponents of school-based scoliosis screening programs argue that, from a public health perspective, adolescent idiopathic scoliosis screening programs are not supported by sufficient evidence; from an economic perspective, school-based scoliosis screening requires a significant investment in human, material, and financial resources, and school-based scoliosis screening programs have not demonstrated significant cost-effectiveness.
The objectives of this study were to screen the prevalence of scoliosis among primary and secondary school students.
Study population Inclusion criteria: adolescents aged 9 to 14 years in primary and secondary schools.Exclusion criteria: congenital scoliosis, traumatic scoliosis, spinal tuberculosis, and other diseases caused by scoliosis.
Screening Methods In this study, 400 adolescents aged 9-12 years (from selected elementary schools) and 13-14 years (from middle schools) in Nanchang were screened. Prior to the assessment, basic information of the participants (including age, sex, height, weight, BMI, and medical history) was collected. Professional rehabilitation therapists evaluated the participants' posture and spinal rotation angles to determine the presence of scoliosis. Participants suspected of having scoliosis underwent further anteroposterior and lateral X-ray examinations for confirmation. Researchers collected data from the anteroposterior and lateral X-rays, including Cobb angle, Risser grade, Nash-Moe grade, and curve type. For participants diagnosed with scoliosis, additional parameters such as plantar pressure distribution, balance function, and respiratory function were collected.
① Plantar Pressure Measurement The specific procedure is as follows: The Footscan high-frequency plantar pressure distribution system (Belgium) was used. Participants stood barefoot on the pressure plate with their feet shoulder-width apart, looking at a target 1 meter ahead. Their arms hung naturally at their sides, and they breathed normally. After maintaining a stable posture for approximately 1 minute, the pressure sensor readings were recorded. Due to variations in height and body weight, the pressure data collected in this study were expressed as percentages of total plantar pressure. The selected parameters included total pressure on the left foot, total pressure on the right foot, forefoot pressure on both sides, and hindfoot pressure on both sides.
②Standard Posture Assessment
The specific procedure is as follows: The participant stood bareback with feet shoulder-width apart, eyes looking straight ahead, arms hanging naturally, and palms facing inward. The following were assessed:
- Whether the shoulders were level;
- Whether the scapulae were symmetrical;
- Whether the inferior angles of the scapulae were at the same level;
- Whether the lumbar concavities were symmetrical;
- Whether the spinous process line was centered.
- Adams Forward Bend Test The specific procedure is as follows: The participant stood upright with knees straight and feet together, then slowly bent forward to approximately 90° with arms extended and palms joined, gradually placing the hands between the knees. During this process, the examiner observed whether the participant's back showed any asymmetry or unevenness.
- Angle of Trunk Rotation (ATR) Measurement A scoliometer was used to measure the degree of spinal rotation during the forward bend test. A reading greater than 5° was considered positive.
- Standing Anteroposterior X-ray of the Spine The specific procedure is as follows: For patients of normal build, the X-ray settings were typically 120 kV, 200 mA, and 1 second. All patients underwent standing anteroposterior X-rays with feet shoulder-width apart, knees naturally extended, facing the X-ray tube, and hands raised with palms forward. If the leg length discrepancy exceeded 2 cm, the shorter side was elevated to keep the pelvis level. The central axis of the X-ray beam was aligned as closely as possible with the sagittal midline of the spine. A measurement scale was placed appropriately. A Cobb angle greater than 10° was diagnostic of scoliosis.
- Conditions
- Scoliosis Idiopathic Adolescent
- Being tested
- not provided
- Keywords
- scoliosis, screening, adolescents, prevalence, cost of screening
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not providedDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Footscan Plantar Pressure Test Parameters
The results of the Footscan plantar pressure test parameters for participants included total pressure on the left foot, total pressure on the right foot, forefoot pressure on both sides, and hindfoot pressure on both sides.
Measured: The process from enrollment to the completion of screening takes about one week.
Physical Examination
The examinee has a bare back, stands naturally, feet shoulder-width apart, eyes flat, arms down, palms facing inward. The examiner observes whether the patient's shoulders are equal in height; whether the angles of both subscapularis are at the same level; whether the lumbar concavity is symmetrical on both sides; whether the iliac crests are equal in height bilaterally; and whether the spinous processes are deviating from the median axis.
Measured: The process from enrollment to the completion of screening takes about one week.
standing anteroposterior X-rays of the spine
Information from standing anteroposterior X-rays of the spine, including Cobb angle, Risser grade, Nash-Moe grade, and curve type
Measured: The process from enrollment to the completion of screening takes about one week.
participants' basic information
basic information from participants, including age, sex, height, weight, BMI, and medical history.
Measured: The process from enrollment to the completion of screening takes about one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start28 Jul 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion28 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nanchang University Affiliated Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wentao Zeng, Nanchang University Affiliated Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802653
- Sponsor's protocol ID
- SFYLL-KY-PJ-2024-057
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Prevalence and Etiology of Adolescent Idiopathic Scoliosis in Nanchang Region
- ClinicalTrials.gov ID
- NCT06802653
- Acronym / sponsor ID
- SFYLL-KY-PJ-2024-057
- Conditions
- Scoliosis Idiopathic Adolescent
- Keywords
- scoliosis, screening, adolescents, prevalence, cost of screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanchang University Affiliated Rehabilitation HospitalUniversity, hospital or other
- Study start
- 28 Jul 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 28 Sep 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
The purpose of this study is to investigate the prevalence and etiology of adolescent idiopathic scoliosis in the Nanchang region. Elementary and middle school students who met the inclusion criteria were included in the study and school-based scoliosis screening was conducted. Diagnosis of suspected scoliosis was determined by physical examination, Adams forward bend test, measurement of trunk rotation angle, and Standing Anteroposterior X-ray of the Spine. The prevalence of suspected scoliosis among elementary and middle school students was calculated. At the same time, the researchers kept detailed records of all costs incurred in the school screening.
Detailed description
Scoliosis is a three-dimensional structural deformity of the spine that includes lateral curvature of the spine in the coronal plane, rotation in the horizontal plane, and alteration of the physiologic curvature in the sagittal plane. Scoliosis has an insidious onset and is often overlooked as there are no obvious symptoms in the early stages. As the disease progresses, it may lead to physical deformities, low back pain, decreased cardiorespiratory function, and may also cause psychological problems such as anxiety and depression. According to statistics, the global prevalence of scoliosis is 2-3%, and adolescent scoliosis is the most common type of scoliosis. The prevalence of scoliosis in adolescent females is higher than that of males. In recent years, the incidence of scoliosis has been on the rise as primary and secondary school students experience increased academic pressure and reduced physical activity and sleep time, which has caused great concern in society.
Scoliosis is thought to be associated with a variety of risk factors, including low BMI, gender differences, racial differences, asymmetrical backpack carrying, low physical activity, and prolonged screen viewing. However, despite the identification of many factors contributing to scoliosis, the comprehensive pathogenesis and natural progression of scoliosis are unknown.
Delaware pioneered school-based scoliosis screening in the 1960s, and it has since gradually spread throughout the United States, Canada, and Europe. Most studies have shown that early scoliosis screening is an effective way to prevent the progression of scoliosis in adolescents and reduce surgery rates. However, the implementation of mandatory scoliosis screening is controversial. Opponents of school-based scoliosis screening programs argue that, from a public health perspective, adolescent idiopathic scoliosis screening programs are not supported by sufficient evidence; from an economic perspective, school-based scoliosis screening requires a significant investment in human, material, and financial resources, and school-based scoliosis screening programs have not demonstrated significant cost-effectiveness.
The objectives of this study were to screen the prevalence of scoliosis among primary and secondary school students.
Study population Inclusion criteria: adolescents aged 9 to 14 years in primary and secondary schools.Exclusion criteria: congenital scoliosis, traumatic scoliosis, spinal tuberculosis, and other diseases caused by scoliosis.
Screening Methods In this study, 400 adolescents aged 9-12 years (from selected elementary schools) and 13-14 years (from middle schools) in Nanchang were screened. Prior to the assessment, basic information of the participants (including age, sex, height, weight, BMI, and medical history) was collected. Professional rehabilitation therapists evaluated the participants' posture and spinal rotation angles to determine the presence of scoliosis. Participants suspected of having scoliosis underwent further anteroposterior and lateral X-ray examinations for confirmation. Researchers collected data from the anteroposterior and lateral X-rays, including Cobb angle, Risser grade, Nash-Moe grade, and curve type. For participants diagnosed with scoliosis, additional parameters such as plantar pressure distribution, balance function, and respiratory function were collected.
① Plantar Pressure Measurement The specific procedure is as follows: The Footscan high-frequency plantar pressure distribution system (Belgium) was used. Participants stood barefoot on the pressure plate with their feet shoulder-width apart, looking at a target 1 meter ahead. Their arms hung naturally at their sides, and they breathed normally. After maintaining a stable posture for approximately 1 minute, the pressure sensor readings were recorded. Due to variations in height and body weight, the pressure data collected in this study were expressed as percentages of total plantar pressure. The selected parameters included total pressure on the left foot, total pressure on the right foot, forefoot pressure on both sides, and hindfoot pressure on both sides.
②Standard Posture Assessment
The specific procedure is as follows: The participant stood bareback with feet shoulder-width apart, eyes looking straight ahead, arms hanging naturally, and palms facing inward. The following were assessed:
- Whether the shoulders were level;
- Whether the scapulae were symmetrical;
- Whether the inferior angles of the scapulae were at the same level;
- Whether the lumbar concavities were symmetrical;
- Whether the spinous process line was centered.
- Adams Forward Bend Test The specific procedure is as follows: The participant stood upright with knees straight and feet together, then slowly bent forward to approximately 90° with arms extended and palms joined, gradually placing the hands between the knees. During this process, the examiner observed whether the participant's back showed any asymmetry or unevenness.
- Angle of Trunk Rotation (ATR) Measurement A scoliometer was used to measure the degree of spinal rotation during the forward bend test. A reading greater than 5° was considered positive.
- Standing Anteroposterior X-ray of the Spine The specific procedure is as follows: For patients of normal build, the X-ray settings were typically 120 kV, 200 mA, and 1 second. All patients underwent standing anteroposterior X-rays with feet shoulder-width apart, knees naturally extended, facing the X-ray tube, and hands raised with palms forward. If the leg length discrepancy exceeded 2 cm, the shorter side was elevated to keep the pelvis level. The central axis of the X-ray beam was aligned as closely as possible with the sagittal midline of the spine. A measurement scale was placed appropriately. A Cobb angle greater than 10° was diagnostic of scoliosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- adolescents aged 9 to 14 years in primary and secondary schools
Key inclusion criteria (4 listed)
- Age 9-14 years old, enrolled in elementary or middle school.
- Local residents of Nanchang, excluding students from special schools for children with physical or intellectual disabilities.
- No underlying medical conditions, and able to complete all examinations without difficulty.
- Willing to participate in the screening and having signed an informed consent form.
Key exclusion criteria (4 listed)
- Severe Medical Conditions: Individuals with severe diseases of the heart, liver, kidneys, endocrine system, or hematopoietic system.
- Neurological or Psychiatric History: Individuals with a history of neurological or psychiatric disorders.
- Refusal to Participate: Individuals who are unwilling or refuse to participate in the screening.
- Severe Osteoporosis: Individuals diagnosed with severe osteoporosis.
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 |
|---|---|---|
| not provided | Diagnostic test | – |
Primary outcome
Footscan Plantar Pressure Test Parameters
Time frame: The process from enrollment to the completion of screening takes about one week.
The results of the Footscan plantar pressure test parameters for participants included total pressure on the left foot, total pressure on the right foot, forefoot pressure on both sides, and hindfoot pressure on both sides.
Physical Examination
Time frame: The process from enrollment to the completion of screening takes about one week.
The examinee has a bare back, stands naturally, feet shoulder-width apart, eyes flat, arms down, palms facing inward. The examiner observes whether the patient's shoulders are equal in height; whether the angles of both subscapularis are at the same level; whether the lumbar concavity is symmetrical on both sides; whether the iliac crests are equal in height bilaterally; and whether the spinous processes are deviating from the median axis.
standing anteroposterior X-rays of the spine
Time frame: The process from enrollment to the completion of screening takes about one week.
Information from standing anteroposterior X-rays of the spine, including Cobb angle, Risser grade, Nash-Moe grade, and curve type
participants' basic information
Time frame: The process from enrollment to the completion of screening takes about one week.
basic information from participants, including age, sex, height, weight, BMI, and medical history.
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 30 May 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic Adolescent, run by Nanchang University Affiliated Rehabilitation Hospital 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 4 inclusion and 4 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 30 May 2025. 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 Liang Ying (china+15279073720, 15270973720@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Footscan Plantar Pressure Test Parameters (time frame: The process from enrollment to the completion of screening takes about one week.). The study lists 4 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 30 May 2025.