Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain

NCT05569486 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-03

No results posted yet for this study

Summary

Investigators have previously shown that specific colors of light can alter nociception. Green light emitting diode exposure (GLED) provides long-lasting antinociception in rodents, through the visual system. No adverse effects were noted, and motor performance was not impaired. Investigator clinical trials have shown GLED is also effective in decreasing pain intensity of fibromyalgia patients and decreasing the number of headache-days per month in migraine patients. However, investigators do not yet understand the mechanisms by which GLED reduces pain.

Understanding the mechanisms of action of GLED will provide additional support for using light therapy as both a treatment and as a possible diagnostic tool. While investigators do not fully understand the mechanisms of action of GLED, investigators do know that it is centrally mediated.

To better elucidate the mechanism of action for GLED, investigators propose a single-blinded randomized placebo-controlled clinical trial to elucidate the central mechanism(s) of action that GLED therapy has in improving fibromyalgia pain, conducted by a team with a successful record of collaboration. Investigator's hypothesis is that GLED decreases neuroinflammation leading to modulation of the signaling in the ascending and descending pain pathways.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Green Light

This is a low-energy device. It produces almost no heat because it uses an LED source for light. The device does not store energy or electrical power that can be discharged later.

Sponsors & Collaborators

  • Banner Alzheimer's Institute

    collaborator OTHER
  • University of Arizona

    lead OTHER

Principal Investigators

  • Mohab M Ibrahim, PhD., MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2029-12-30
Completion
2029-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569486 on ClinicalTrials.gov