Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-15
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
956 Participants
are grouped into 2 trial groupsGroup A: Melatonin phase delay
Group B: Melatonin phase nromal, controls
Trial outcomes
Primary outcomes
1
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
Time frame
Routine follow-up visits will be scheduled 6 months apart up to 36 months2
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.
Time frame
Routine follow-up visits will be scheduled 6 months apart up to 36 monthsSecondary outcomes
1
Circadian rhythm Measurements
circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)
Time frame
Baseline2
Body mass index
Changes in height, weight and body mass index
Time frame
Routine follow-up visits will be scheduled 6 months apart up to 36 months3
Sleep quality
The Pediatric Sleep Questionnaire (PSQ) is used to assess sleep quality
Time frame
Baseline4
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov