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

ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

Qualifiers

18 years or older who can speak and understand English

Meets the diagnostic criteria for fibromyalgia accroding to the 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria.

Average numeric pain score of 5 out of 10 or greater over the 10 weeks prior to enrolling in the study, and failure of medical therapy to control their pain.

Disqualifiers

Serious mental illness defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality. This will be assessed during the screening interview. Patients with psychiatric disorders will have their medical record reviewed prior to enrollment

History of color blindness or uncorrected cataracts

Subjects receiving remuneration for their medical condition.

Genotype of low affinity binders for translocator protein, (TSPO), as patients with low affinity binding TSPO may not have adequate uptake for the radioactive tracer used for the PET scan.

Trial design

Treatments tested in this trial

  • Green Light

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Arizona

Lead sponsor

Banner Alzheimer's Institute

Collaborator