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.
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.
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.
Parallel
Green Light
DeviceThis 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.
Decreased activation of glial cells.
By exposure to GLED investigators hypothesize that glial cells will be decreased, investigators will measure this by using positron emission tomography (PET) scan, scans will be conducted at baseline and the end of study
Decreasing Central Nervous System inflammation (CNS), Increasing Endorphins.
By exposure to GLED, investigators hypothesize that inflammation in the CSF will be decreased and increased endorphin levels, this will be demonstrated by measuring cerebrospinal fluid (CSF) cytokines at baseline and at the end of study.
Decreasing the activity of ascending pain pathway, and increasing the activity the descending pain pathway
Decreasing the activity of the ascending pain pathway shown by decreased pain scores from repeated noxious stimulation (temporal summation) as compared to baseline, increasing the activity of the descending pain pathway measured by increasing the pain threshold to noxious stimulation while patients submerge their hand in an ice water bath as compared to baseline.
Improvement in Fibromyalgia Impact Questionnaire score
These will be completed at baseline and at the end of study. A survey to evaluate the effects of Fibromyalgia. The scale ranges from 0-100. 0 means no impact. 100 means there is a severe negative impact secondary to fibromyalgia. The scale is subjective in nature.
Decreased objective and subjective pain scores to mechanical and thermal stimulation
Investigators will compare pain scores at baseline to end of study. The scale ranges from 0-100%. This is a reported value by the patient which is subjective in nature.
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University of Arizona
Lead sponsor
Banner Alzheimer's Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
