Actively Recruiting
Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2026-05-19
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adolescent idiopathic scoliosis (AIS), a common spinal condition in children aged 10 to 15 years characterized by a sideways curvature of the spine without known causes like congenital or neuromuscular disorders. The study explores whether morning bright light therapy can reduce the progression rate of AIS and possibly prevent its new development by addressing circadian rhythm disruptions common during puberty. This is a prospective, single-blind, randomized controlled trial aimed at identifying a non-drug way to manage scoliosis through circadian rhythm adjustment. Participants with AIS and an evening chronotype will be randomly assigned to one of two groups. The intervention group will use a portable light therapy device emitting blue light (480 nm, 400 lux) for 15 to 30 minutes each weekday morning upon waking for six months, combined with a one-time sleep hygiene education session. The control group will receive the same sleep hygiene education without the light therapy device. Regular phone calls will support adherence in the intervention group, and follow-up visits with spine X-rays will occur every six months for at least two years to monitor scoliosis progression. Children with evening chronotype but no scoliosis will also be randomized and monitored annually. Throughout the study, participants will attend follow-up visits every six months for up to 24 months, where spinal curvature angles and trunk rotation will be measured. Additional assessments include questionnaires on scoliosis impact, self-reported and biological circadian rhythm measurements, and gene expression analysis related to circadian markers at baseline and six months. The study will monitor adherence to therapy through phone follow-ups and assess safety and efficacy through these clinical and biological outcomes over the study duration.
CONDITIONS
Brief Title
Effect of Bright Light Therapy on Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 and 15 years
- Evening chronotype based on a specific questionnaire score below 12
- Radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at initial visit
- Skeletally immature with Risser sign 0-3 and major Cobb angle less than 40 degrees at baseline
- Written informed consent/assent from participant and guardian
- Willing and able to comply with study protocol, including device use and follow-ups
You will not qualify if you...
- Plans to move outside the study area within 24 months
- Use of medications affecting circadian rhythm in past 3 months (e.g., lithium, melatonin)
- Travel across two or more time zones in past 3 months or planned during study
- Any eye diseases that could worsen with light therapy (e.g., glaucoma, retinal disease)
- Diagnosed sleep disorders or medical conditions interfering with sleep (e.g., narcolepsy, moderate-to-severe eczema)
- Severe chronic health issues that may affect outcomes, including syndromic or neuromuscular scoliosis, history of spine surgery or trauma, spinal tumor, leg length difference over 20 mm, poorly controlled diabetes, liver or kidney disease, malabsorption, or severe obesity (BMI z-score ≥ 3)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants in the experimental group use a portable light therapy device emitting blue light for 15-30 minutes each weekday morning immediately upon waking, along with standardized sleep hygiene education, for 6 consecutive months. The control group receives sleep hygiene education only.
Daily weekday use of light therapy device for 15-30 minutes in the experimental group; one-time sleep hygiene education session for all participants; regular telephone follow-ups for the experimental group to monitor adherence
Duration - Up to 24 months
Participants undergo routine follow-up visits with radiographic assessment to evaluate scoliosis curve progression and other outcomes.
Follow-up visits every 6 months for up to 24 months
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Wenzhou Medical University
Zhejiang, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiangyang Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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