Effect of Bright Light Therapy on Idiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-15
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
This trial aims to investigate whether morning bright light therapy can reduce the progression rate of idiopathic scoliosis in children and potentially prevent its de novo development.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 10 and 15 years.
Classified as evening chronotype based on the reduced Horne-Östberg Morningness-Eveningness Questionnaire (rMEQ), defined as a score < 12.
Has undergone radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at the initial clinic visit.
Skeletally immature (Risser sign 0-3) with a major Cobb angle < 40 degrees at baseline.
Disqualifiers
Plans to relocate outside the study area within the next 24 months.
Use of medications that may interfere with circadian rhythm within the past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).
Trans-meridian travel across at least two time zones within the past 3 months or anticipated during the study period.
Presence of any eye disease (e.g., glaucoma, retinal disease, macular degeneration) that could be exacerbated by or interfere with light therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Bright Light Therapy
DeviceBright Light Therapy plus Sleep Hygiene Education. Use of a portable light therapy device emitting narrow-band blue light (peak wavelength 480 nm) at an intensity of 400 lux, for 15-30 minutes each weekday morning immediately upon waking, for 6 consecutive months.
Sleep Hygiene Education
BehavioralSleep Hygiene Education Only
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Bright Light Therapy plus Sleep Hygiene EducationExperimental treatment 1 intervention
Group B: Sleep Hygiene Education OnlyActive comparator 1 intervention
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 24 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 24 monthsSecondary outcomes
1
Scoliosis Research Society-22 (SRS-22) questionnaire
The SRS-22 aims to evaluate health-related quality of life (HRQOL) in patients with idiopathic scoliosis. The SRS-22 specifically addresses areas affected by spinal deformities-such as pain, self-perception, function, mental health, and satisfaction with treatment. Consequently, it offers a focused approach to understanding the patient experience.
Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months2
Self-Report Circadian rhythm Measurements
Circadian rhythm as assessed by the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ)
Time frame
At baseline and months 63
Objective Circadian Measurements: Dim-light melatonin onset (DLMO)
Dim-light melatonin onset (express as time value hh:mm) is determined by 6-hours salivary melatonin collected at 1-hour interval.
Time frame
At baseline and months 64
Gene Expression of Circadian Biomarkers
Change in mRNA expression levels of Circadian Genes such as Bmal1 in peripheral blood mononuclear cells as measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Time frame
At baseline and months 6Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
The Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting325000, Zhejiang, Zhejiang
China
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Source ClinicalTrials.gov