Scoliosis IdiopathicNCT06502613
Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children
An observational study of Scoliosis Idiopathic and Circadian Rhythm, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study aimed to investigate the prevalence and clinical significance of melatonin phase delay in children with new onset and progressive idiopathic scoliosis (IS). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Scoliosis Idiopathic, Circadian Rhythm, Melatonin
- How many people
- 956 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 15 Jul 2027
- 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 6 to 15 years
- All sexes
- Child
Study population: * Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis * History of previous spine surgery or spinal injury * Tumor or malignant tumor in the spine and brain * Leg length discrepancy more than 20 mm * Fail to fulfill the questionnaire or refuse to attend any further evaluation * Plans to relocate within the next 24 months
Who may be able to join
- Collect saliva according to standards and complete melatonin testing
- Complete scoliometer or X-ray assess scoliosis
- Skeletally immature (Risser Sign 0-3)
- Age between 6 and 15
- Patients can understand and complete the MEQ-5, PSQ, and PSQI Questionnaire at baseline and follow-up visits
- Informed Consent Form signed by subject or the guardian
Who cannot join
- -
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, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Chongan Huang, MD, 86-577-88006815, huangchongan@126.com
About this study
Official title: Melatonin Phase Delay May Increase Risk of Children and Adolescent Idiopathic Scoliosis.
This study aimed to investigate the prevalence and clinical significance of melatonin phase delay in children with new onset and progressive idiopathic scoliosis (IS).
Read the detailed description
Scoliosis is a three-dimensional (3D) structural deformity of the spine defined as a radiological lateral curvature of the spine in the coronal plane of ≥10°. The worldwide prevalence of spinal curves ranges from 0.5% to 5% in children aged 10-16 years. The aetiopathogenesis of idiopathic scoliosis includes genetic abnormalities, neuromuscular, biomechanics, bone metabolism, hormonal factors, and lifestyle explorations. However, none of these factors has been established conclusively as a direct cause of IS.
Etiological research is crucial for the treatment and prevention of idiopathic scoliosis (IS). "Melatonin deficiency" was once one of the most promising etiological hypotheses for IS. Blood melatonin deficiency and dysfunction of its signaling pathways are widely suspected to play a significant role in adolescent idiopathic scoliosis (AIS). In 1994, Machida et al were the first to discover that melatonin deficiency caused by pinealectomy could induce changes similar to idiopathic scoliosis in chickens. Bipedal mice (standing and walking on hind limbs) that underwent pinealectomy or bipedal C57BL/6 mice naturally lacking melatonin were subsequently shown to develop scoliosis as well.
However, the relationship between circulating melatonin levels and AIS in human adolescents has shown significant discrepancies among studies. Whether IS patients have a melatonin deficiency remains to be seen. While Ahuja et al found that daytime melatonin levels in AIS patients were lower than those in normal controls, most other researchers reported no significant differences in serum melatonin, urinary melatonin metabolite levels during the day and night between IS patients and controls. Goultidis et al. even found that melatonin levels in AIS patients were higher than those in the control group. Current studies only measure melatonin concentration. The impact of changes in melatonin secretion patterns on scoliosis has not yet been reported. Our cross-sectional study found that the onset and peak of melatonin secretion were both delayed in patients with scoliosis compared to the control group. The delayed melatonin secretion could be a potential cause of scoliosis.
To fill those gaps, investigators will perform a prospective, unrandomized, observational cohort study at a scoliosis center to determine the prevalence and significance of melatonin phase delay in children with IS. All subjects underwent scoliosis screening led by the Zhejiang Provincial Government. Those with a scoliometer-measured ATR > 5 degrees and a Cobb angle > 10 degrees on X-ray were diagnosed with scoliosis. Individuals with an ATR > 5 degrees but a Cobb angle < 10 degrees on X-ray, or an ATR < 5 degrees, were classified as normal. Subjects screened with the Morning and Evening Questionnaire-5 (MEQ-5), the Pediatric Sleep Questionnaire (PSQ), and the Pittsburgh Sleep Quality Index (PSQI) are used to assess circadian rhythm and sleep quality. Routine follow-up visits will be scheduled 6 months apart up to at least 36 months to assess the new onset scoliosis. Patients diagnosed with scoliosis underwent X-ray examinations, while those not diagnosed with scoliosis were uniformly screened for scoliosis in Zhejiang Province during 2024-2027
- Conditions
- Scoliosis Idiopathic, Circadian Rhythm, Melatonin
- Keywords
- Melatonin, Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin phase delay | Salivary melatonin testing shows Melatonin phase delay | |
| Melatonin phase nromal, controls | Salivary melatonin testing shows normal, control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Curve Angle
A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Angle of Trunk Rotation
In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Secondary outcomes (4)
Circadian rhythm Measurements
circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)
Measured: Baseline
Body mass index
Changes in height, weight and body mass index
Measured: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Sleep quality
The Pediatric Sleep Questionnaire (PSQ) is used to assess sleep quality
Measured: Baseline
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 956 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimin Wang, MD, Study chair, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502613
- Sponsor's protocol ID
- SAHoWMU-CR2024-08-215
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Phase Delay May Increase Risk of Children and Adolescent Idiopathic Scoliosis.
- ClinicalTrials.gov ID
- NCT06502613
- Acronym / sponsor ID
- SAHoWMU-CR2024-08-215
- Conditions
- Scoliosis Idiopathic, Circadian Rhythm, Melatonin
- Keywords
- Melatonin, Scoliosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 956 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 16 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.
This study aimed to investigate the prevalence and clinical significance of melatonin phase delay in children with new onset and progressive idiopathic scoliosis (IS).
Detailed description
Scoliosis is a three-dimensional (3D) structural deformity of the spine defined as a radiological lateral curvature of the spine in the coronal plane of ≥10°. The worldwide prevalence of spinal curves ranges from 0.5% to 5% in children aged 10-16 years. The aetiopathogenesis of idiopathic scoliosis includes genetic abnormalities, neuromuscular, biomechanics, bone metabolism, hormonal factors, and lifestyle explorations. However, none of these factors has been established conclusively as a direct cause of IS.
Etiological research is crucial for the treatment and prevention of idiopathic scoliosis (IS). "Melatonin deficiency" was once one of the most promising etiological hypotheses for IS. Blood melatonin deficiency and dysfunction of its signaling pathways are widely suspected to play a significant role in adolescent idiopathic scoliosis (AIS). In 1994, Machida et al were the first to discover that melatonin deficiency caused by pinealectomy could induce changes similar to idiopathic scoliosis in chickens. Bipedal mice (standing and walking on hind limbs) that underwent pinealectomy or bipedal C57BL/6 mice naturally lacking melatonin were subsequently shown to develop scoliosis as well.
However, the relationship between circulating melatonin levels and AIS in human adolescents has shown significant discrepancies among studies. Whether IS patients have a melatonin deficiency remains to be seen. While Ahuja et al found that daytime melatonin levels in AIS patients were lower than those in normal controls, most other researchers reported no significant differences in serum melatonin, urinary melatonin metabolite levels during the day and night between IS patients and controls. Goultidis et al. even found that melatonin levels in AIS patients were higher than those in the control group. Current studies only measure melatonin concentration. The impact of changes in melatonin secretion patterns on scoliosis has not yet been reported. Our cross-sectional study found that the onset and peak of melatonin secretion were both delayed in patients with scoliosis compared to the control group. The delayed melatonin secretion could be a potential cause of scoliosis.
To fill those gaps, investigators will perform a prospective, unrandomized, observational cohort study at a scoliosis center to determine the prevalence and significance of melatonin phase delay in children with IS. All subjects underwent scoliosis screening led by the Zhejiang Provincial Government. Those with a scoliometer-measured ATR > 5 degrees and a Cobb angle > 10 degrees on X-ray were diagnosed with scoliosis. Individuals with an ATR > 5 degrees but a Cobb angle < 10 degrees on X-ray, or an ATR < 5 degrees, were classified as normal. Subjects screened with the Morning and Evening Questionnaire-5 (MEQ-5), the Pediatric Sleep Questionnaire (PSQ), and the Pittsburgh Sleep Quality Index (PSQI) are used to assess circadian rhythm and sleep quality. Routine follow-up visits will be scheduled 6 months apart up to at least 36 months to assess the new onset scoliosis. Patients diagnosed with scoliosis underwent X-ray examinations, while those not diagnosed with scoliosis were uniformly screened for scoliosis in Zhejiang Province during 2024-2027
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin phase delay | – | –Salivary melatonin testing shows Melatonin phase delay |
| Melatonin phase nromal, controls | – | –Salivary melatonin testing shows normal, control group |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- * Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis * History of previous spine surgery or spinal injury * Tumor or malignant tumor in the spine and brain * Leg length discrepancy more than 20 mm * Fail to fulfill the questionnaire or refuse to attend any further evaluation * Plans to relocate within the next 24 months
Key inclusion criteria (6 listed)
- Collect saliva according to standards and complete melatonin testing
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scoliosis Curve Angle
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method
Angle of Trunk Rotation
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.
4 secondary outcomes
Circadian rhythm Measurements
Time frame: Baseline
Body mass index
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months
Sleep quality
Time frame: Baseline
Sleep quality
Time frame: Baseline
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 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Scoliosis Idiopathic
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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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.
Aimin Wang, MD study chair
Second Affiliated Hospital of Wenzhou Medical University
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 and Circadian Rhythm, run by Second Affiliated Hospital of Wenzhou 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 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 Xiangyang Wang, MD (86-13506663458, Xiangyangwang@wmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Curve Angle (time frame: Routine follow-up visits will be scheduled 6 months apart up to 36 months). The study lists 2 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 16 Jul 2024.