Light color therapy to help chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this pilot, randomized, double-blind, crossover trial, adults with fibromyalgia or chronic widespread pain will receive two lighting conditions for 2 hours daily during two separate 7-day periods, with a 1-week washout in between. Participants and study staff are blinded to the light condition, and outcomes include self-reported pain and pain-related interference as well as quantitative sensory testing. The study uses commercially available TUO light bulbs and monitors light intensity to ensure twofold illumination over ambient room light. Baseline assessments cover demographics, validated patient-reported outcomes, and objective pain sensitivity measures; follow-up assessments occur at multiple timepoints across the trial duration (approximately 35 days total).

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults ≥ 18 years of age.
* Individuals who have been diagnosed with fibromyalgia or suffer from chronic widespread pain and fatigue.
* An average pain severity ≥4 on the 0-10 NRS over the month prior to enrollment.
* Pain symptoms present for 3 months or longer.
* Pain must be present in 4 out of 5 body regions.
* A score of ≥7 on the Widespread pain index (WPI) and ≥5 on the symptom severity scale (SSS), or 4-6 on the WPI and ≥9 on the SSS in the 2016 Fibromyalgia Questionnaire.
* Willingness to adjust light levels in home environment so that the illumination (measured in lux) provided by the light bulbs is twice the ambient room illumination (also measured in lux).
* Willingness to use study lightbulbs for 2 consecutive hours a day for 7 consecutive days according to study specifications for both conditions (total of 14 days using lightbulbs)
* Alert and oriented, and able to provide informed consent
* Ability to read and speak English to complete validated questionnaires.

Exclusion Criteria:

* Vision disorders or conditions resulting in severe vision impairment or blindness
* Individuals with self-report of color blindness, uveitis or cataracts.
* Prisoner Status
* Pregnancy
* History of photosensitivity or sensitivity to scintillating (mildly flickering) light.
* History of seizure disorder.
* Individuals living in households with people who have a history of seizure disorders.
* Analgesic treatment plan changes anticipated in the next 3 months (surgery, analgesic medication changes, injections, pain procedures, etc.).
* Other history or condition that would, in the investigator's judgment, indicate that the individual would highly likely be non-compliant with the study or unsuitable for the study

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Matt Mauck, MD, PhD — UNC Chapel Hill School of Medicine
• Study coordinator: Matthew Mauck, MD, PhD
• Email: matt_mauck@med.unc.edu
• Phone: 919-966-5136

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Colored-light pain relief and brain mapping in chronic musculoskeletal pain

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• Understanding how the brain processes chronic pain in children

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  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT05814497

• Respiratory Function in Fibromyalgia: A Look at Breath and Muscle Health in Women

  This study compares respiratory function, muscle strength, and quality of life between women with fibromyalgia and healthy women to see if fibromyalgia affects breathing and muscle performance.

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• Interoceptive Sensitivity and Central Sensitization in Fibromyalgia

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• Psychologically Informed Physical Therapy (PIPT) for Fibromyalgia delivered online

  A small online program tests if a psychologically informed physical therapy approach is feasible, acceptable, and safe for adults with fibromyalgia to help manage symptoms and improve daily functioning.

  Recruiting IRCCS San Raffaele Roma · Rome, Rome · NCT07865403

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.