Bright Light Therapy: Bright 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: Sleep Hygiene Education Only
Study summary
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
Sex
ALL
Min age
10 Years
Max age
15 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 10 and 15 years.
2. Classified as evening chronotype based on the reduced Horne-Östberg Morningness-Eveningness Questionnaire (rMEQ), defined as a score \< 12.
3. Has undergone radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at the initial clinic visit.
4. Skeletally immature (Risser sign 0-3) with a major Cobb angle \< 40 degrees at baseline.
5. Written informed consent/assent provided by the participant and legal guardian.
6. Willing and able to comply with the study protocol, including device use and scheduled follow-ups.
Exclusion Criteria:
1. Plans to relocate outside the study area within the next 24 months.
2. Use of medications that may interfere with circadian rhythm within the past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).
3. Trans-meridian travel across at least two time zones within the past 3 months or anticipated during the study period.
4. Presence of any eye disease (e.g., glaucoma, retinal disease, macular degeneration) that could be exacerbated by or interfere with light therapy.
5. Clinically diagnosed sleep disorder (e.g., narcolepsy, restless legs syndrome) or prominent medical condition known to interfere with sleep continuity and quality (e.g., moderate-to-severe eczema).
6. Severe chronic health conditions that could confound study outcomes, including but not limited to:
* Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.
* History of spine surgery or significant spinal trauma.
* Spinal tumor.
* Leg length discrepancy \> 20 mm.
* Other severe chronic diseases (e.g., poorly controlled diabetes, chronic liver or renal disease, malabsorption syndromes).
* Severe obesity (body mass index z-score ≥ 3).
Primary outcome measure(s)
Scoliosis Curve Angle — Routine follow-up visits will be scheduled 6 months apart up to 24 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 24 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)
Facility
City
Region
Status
The Second Affiliated Hospital of Wenzhou Medical University
Zhejiang
Zhejiang
Recruiting
More Second Affiliated Hospital of Wenzhou Medical University trials in China
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.
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