Skip to content

Effect of Bright Light Therapy on Idiopathic Scoliosis

Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07424703
Enrollment
120
Registered
2026-02-20
Start date
2025-09-01
Completion date
2028-09-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Sleep Phase, Eveningness, Idiopathic Scoliosis

Brief 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.

Detailed description

Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal deformity, characterized by a lateral spinal curvature of ≥10° in the absence of congenital or neuromuscular abnormalities. Afflicting 3-4% of children worldwide, AIS emerges during the vulnerable period of puberty, yet its underlying etiology remains poorly understood. Adolescence is also associated with a gradual shift in circadian rhythm, characterized by an intrinsic phase delay and increased evening preference that coincides with pubertal development. Notably, our unpublished data reveal that the prevalence of evening chronotype among children with idiopathic scoliosis may reach 20-30%, significantly higher than in the general pediatric population. While circadian disruption is known to adversely affect bone metabolism, muscle mass, and postural control in adults, its impact on children-particularly those with circadian vulnerability-remains unexplored. We hypothesize that the circadian phase delay and associated sleep disruption during the peripubertal period may represent a modifiable risk factor contributing to the onset or progression of spinal curvature. Bright light therapy is a well-established intervention for circadian rhythm sleep-wake disorders, capable of advancing the circadian phase and stabilizing sleep patterns. This prospective, single-blind, randomized controlled trial will investigate the efficacy of bright light therapy in modifying the natural history of idiopathic scoliosis. Children with idiopathic scoliosis and a confirmed evening chronotype will be randomized into one of two groups. The Intervention Group will receive a combination of morning bright light exposure and standardized sleep hygiene education. Participants will be instructed to wear a portable light therapy device (480nm, 400LUX) for 15-30 minutes each weekday morning immediately upon waking, for a duration of 6 months. The Control Group will receive identical sleep hygiene education but no light therapy device, serving as an active comparator to control for the effects of increased health awareness and behavioral recommendations. To ensure adherence, the intervention group will receive regular telephone follow-ups to monitor device usage, address challenges, and encourage compliance; flexible adjustment of exposure timing (e.g., mid-morning) will be permitted if morning adherence proves difficult. For all participants with scoliosis, routine follow-up visits with radiographic assessment will be scheduled at 6-month intervals for at least 24 months to evaluate curve progression. Additionally, children with an evening chronotype but without scoliosis at baseline will also be randomized to the same intervention arms and will undergo annual scoliosis screening as part of an ongoing provincial health initiative. This study may identify a safe, non-pharmacological intervention targeting circadian rhythm as a novel approach to scoliosis management.

Interventions

DEVICEBright 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.

BEHAVIORALSleep Hygiene Education

Sleep Hygiene Education Only

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The radiologists measuring Cobb angles will be blinded to treatment allocation.

Eligibility

Sex/Gender
ALL
Age
10 Years to 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).

Design outcomes

Primary

MeasureTime frameDescription
Scoliosis Curve AngleRoutine follow-up visits will be scheduled 6 months apart up to 24 monthsA 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 RotationRoutine follow-up visits will be scheduled 6 months apart up to 24 monthsIn 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.

Secondary

MeasureTime frameDescription
Scoliosis Research Society-22 (SRS-22) questionnaireRoutine follow-up visits will be scheduled 6 months apart up to 24 monthsThe 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.
Self-Report Circadian rhythm MeasurementsAt baseline and months 6Circadian rhythm as assessed by the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ)
Objective Circadian Measurements: Dim-light melatonin onset (DLMO)At baseline and months 6Dim-light melatonin onset (express as time value hh:mm) is determined by 6-hours salivary melatonin collected at 1-hour interval.
Gene Expression of Circadian BiomarkersAt baseline and months 6Change 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).

Countries

China

Contacts

CONTACTXiangyang Wang
Xiangyangwang@wmu.edu.com13506663458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026