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Recruiting Observational

Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children

NCT06502613 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-08-01
Last updated
2024-07-16

Condition(s) studied

Scoliosis IdiopathicCircadian RhythmMelatonin

Study 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).

Eligibility

Sex
ALL
Min age
6 Years
Max age
15 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: \-

Primary outcome measure(s)

  • Scoliosis Curve Angle — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06502613 on ClinicalTrials.gov ↗ ← All trials in China