RecruitingNot ApplicableNCT07424703

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


Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Enrollment

120 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 15 Years

Inclusion Criteria6

  • 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.
  • Written informed consent/assent provided by the participant and legal guardian.
  • Willing and able to comply with the study protocol, including device use and scheduled follow-ups.

Exclusion Criteria12

  • 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.
  • 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).
  • 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).

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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


Locations(1)

The Second Affiliated Hospital of Wenzhou Medical University

Zhejiang, Zhejiang, China

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NCT07424703


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