Morning bright light therapy to slow or prevent adolescent idiopathic scoliosis

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

This will try morning bright light therapy to see if it can slow curve progression or prevent new scoliosis in 10–15-year-olds who have evening sleep patterns.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 10 Years to 15 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University (other)
• Locations: 1 site (Zhejiang, Zhejiang)
• Trial ID: NCT07424703 on ClinicalTrials.gov

What this trial studies

This single-blind, randomized controlled trial enrolls 10–15-year-old patients with idiopathic scoliosis who are classified as evening chronotypes. Participants are randomized to daily morning bright light therapy plus sleep hygiene education or to sleep hygiene education alone, with baseline standing full-spine X-rays and scheduled follow-up radiographs to track Cobb angle changes. Eligible participants are skeletally immature (Risser 0–3) with major Cobb angles under 40° and must be able to use the light device and attend follow-up visits. The trial tests whether advancing circadian phase during the peripubertal period can alter the natural history of scoliosis progression or de novo onset.

Who should consider this trial

Good fit: Ideal candidates are 10–15-year-olds who are evening chronotypes (rMEQ < 12), are skeletally immature (Risser 0–3), have a major Cobb angle < 40°, and can comply with device use and follow-up visits.

Not a fit: Patients who are not evening types, who are skeletally mature, have Cobb angles ≥ 40°, have congenital or neuromuscular scoliosis, have eye disease, or are taking medications that affect circadian rhythm are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this noninvasive approach could slow curve progression, lower the need for bracing or surgery, and improve sleep and bone-related health during puberty.

How similar studies have performed: Bright light therapy is an established treatment for circadian rhythm sleep-wake disorders, but applying it to alter scoliosis progression is novel and has not been validated.

Eligibility criteria

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).

Where this trial is running

Zhejiang, Zhejiang

• The Second Affiliated Hospital of Wenzhou Medical University — Zhejiang, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Xiangyang Wang

Conditions: Idiopathic Scoliosis, Eveningness, Delayed Sleep Phase