NCT05569486

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

Elucidating the Central Mechanism(s) of Action for Green Light Therapy in Managing Chronic Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After a patient is consented, investigators will collect the baseline Fibromyalgia Impact Questionnaire survey (FIQ), thermal and mechanical pain detection and tolerance threshold, conditioned pain modulation (CPM), collect cerebrospinal fluid (CSF), and obtain positron emission tomography scan (PET scan) for microglia baseline activity. It is expected that the PET scan will take place on different day given the time needed and preparation for the completion of a PET scan. Investigators expect the baseline value collections to take 1-2 days to complete. Once all baseline values are obtained, the light therapy exposure will begin. The start of light exposure will be considered the start of Week 1. Investigators will follow up with the patient over the phone every 2 weeks +/- 1 week to ensure safety and compliance and to answer any questions the patient may have. Recruited patients will also have investigator's contact information to contact investigators with any urgent questions. At the end of Week 10, investigators will obtain the final values for the FIQ survey, thermal and mechanical pain detection and tolerance threshold, CPM, collect CSF, and obtain PET scan.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-12-01
• Primary completion: 2029-12-30
• Completion: 2029-12-30
• First posted: 2022-10-06
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study