Light Bulb Stimuli to Reduce Chronic Pain

NCT07825792 | Not Yet Recruiting FDA Device

• 1 other identifier: 24-1180
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized, double-blind, crossover clinical trial will evaluate the feasibility and preliminary efficacy of chromatic (colored) light exposure for reducing pain severity and pain sensitivity in adults with fibromyalgia or chronic widespread pain and fatigue. Participants will complete daily symptom surveys throughout the study and undergo patient-reported outcome assessments and quantitative sensory testing at multiple timepoints. Participants will be randomized to receive either S-cone stimulating chromatic light or equal-energy white light for 2 hours daily over a 7-day treatment period. Following a 1-week washout, participants will cross over to the alternate condition. Outcomes will examine feasibility, changes in pain severity, pain interference, and measures of pain sensitivity. Total study duration is approximately 35 days.

Conditions

Fibromyalgia; Musculoskeletal Pain

Keywords

Fibromyalgia; Musculoskeletal Pain; Analgesia

Outcome Measures

Primary Outcomes (3)

• Percentage of participants completing follow-up visits after each intervention period

  Feasibility will be assessed by percentage of participants completing follow-up visits after each intervention period.

  Throughout study participation (35 days)

• Percentage of daily flash surveys completed during the two 7-day stimulation periods

  Feasibility will be assessed by percentage of daily flash surveys completed during the two 7-day stimulation periods (14 eligible survey time points).

  Throughout the two 7-day stimulation periods (14 eligible survey timepoints during active treatment period)

• Percentage of prescribed light stimulation sessions completed based on participant self-report

  Feasibility will be assessed by percentage of prescribed light stimulation sessions completed based on participant self-report.

  Throughout the two 7-day stimulation periods (14 eligible survey timepoints during active treatment period)

Secondary Outcomes (4)

• Pain Intensity

  Baseline, post-treatment period 1 (Day 14), post-treatment period 2 (Day 28), and follow-up (Day 35)

• Pressure Pain Threshold

  Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).

• Temporal Summation

  Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).

• Conditioned Pain Modulation

  Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).

Study Arms (2)

S-cone stimulating chromatic light first followed by equal-energy white light

EXPERIMENTAL

Participants randomized to this sequence will receive S-cone stimulating chromatic light during the first treatment period, followed by equal-energy white (flickering along the L/M axis) light during the second treatment period. Each treatment period consists of 2 hours of daily light exposure for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m., delivered using programmed "TUO" light bulbs. The two treatment periods are separated by a 1-week washout period. Participants complete daily symptom surveys, patient-reported outcome measures, and quantitative sensory testing throughout the study.

Device: S-Cone Stimulating Chromatic Light; Device: Equal-Energy White Light

Equal-energy white light first followed by S-cone stimulating chromatic light

EXPERIMENTAL

Participants randomized to this sequence will receive equal-energy white light (flickering along the L/M axis) during the first treatment period, followed by S-cone stimulating chromatic light during the second treatment period. Each treatment period consists of 2 hours of daily light exposure for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m., delivered using programmed "TUO" light bulbs. The two treatment periods are separated by a 1-week washout period. Participants complete daily symptom surveys, patient-reported outcome measures, and quantitative sensory testing throughout the study.

Device: S-Cone Stimulating Chromatic Light; Device: Equal-Energy White Light

Interventions

S-Cone Stimulating Chromatic Light DEVICE

Participants receive exposure to S-cone stimulating chromatic light delivered via programmed TUO light bulbs. Light is administered for 2 hours daily for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m.. Participants use the light in their home environment while engaging in normal daily activities. Light intensity is maintained at a minimum of twice the ambient room illumination using an illuminometer provided by the study. This intervention is designed to selectively stimulate short-wavelength-sensitive (S-cone) photoreceptors.

Equal-energy white light first followed by S-cone stimulating chromatic light; S-cone stimulating chromatic light first followed by equal-energy white light

Equal-Energy White Light DEVICE

Participants receive exposure to a light that appears equal-energy white that flickers along the L/M axis delivered via programmed TUO light bulbs. Light is administered for 2 hours daily for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m. Participants use the light in their home environment while engaging in normal daily activities. Light intensity is maintained at a minimum of twice the ambient room illumination using an illuminometer provided by the study. This intervention serves as the control condition for comparison with the S-cone stimulating chromatic light intervention.

Equal-energy white light first followed by S-cone stimulating chromatic light; S-cone stimulating chromatic light first followed by equal-energy white light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Musculoskeletal Pain; Agnosia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Matt Mauck, MD, PhD

  UNC Chapel Hill School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Mauck, MD, PhD

CONTACT

919-966-5136; matt_mauck@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)