Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children

NCT06502613 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2024-08-215
• Study Type: observational
• Target: 956
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Scoliosis Idiopathic; Circadian Rhythm; Melatonin

Keywords

Melatonin; Scoliosis

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Routine follow-up visits will be scheduled 6 months apart up to 36 months

Secondary Outcomes (4)

• Circadian rhythm Measurements

  Baseline

• Body mass index

  Routine follow-up visits will be scheduled 6 months apart up to 36 months

• Sleep quality

  Baseline

• Sleep quality

  Baseline

Study Arms (2)

Melatonin phase delay

Salivary melatonin testing shows Melatonin phase delay

Melatonin phase nromal, controls

Salivary melatonin testing shows normal, control group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Aimin Wang, MD

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY CHAIR

Central Study Contacts

Xiangyang Wang, MD

CONTACT

86-13506663458; Xiangyangwang@wmu.edu.com

Chongan Huang, MD

CONTACT

86-577-88006815; huangchongan@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CN (1)