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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT05569486
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Green Light — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Green light-emitting diode (GLED)
    Subjects randomized to this arm will be exposed to GLED 2 hours a day for 10 weeks
  • Placebo Comparator: White light-emitting diode (WLED)
    Subjects randomized to this arm will be exposed to WLED 2 hours a day for 10 weeks

Primary Outcome Measure

Decreased activation of glial cells. [ Time Frame: [Time Frame: 10 - 22 weeks, depending on study arm] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Banner University Medical Center Multispecialty Services ClinicTucsonArizona85711-

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Banner University Medical Center Multispecialty Services Clinic· Tucson, AZ

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