What is the mechanism of action of this treatment?

Common treatments for Fibromyalgia, such as Green Light Emitting Diode Exposure (GLED), work by decreasing neuroinflammation and modulating the signaling in the ascending and descending pain pathways. This is crucial for Fibromyalgia patients because neuroinflammation and dysregulated pain pathways are key contributors to their chronic pain. By targeting these mechanisms, treatments like GLED can help reduce pain intensity and improve the overall quality of life. Additionally, other treatments often focus on improving sleep, reducing fatigue, and managing comorbid conditions, which further aid in alleviating symptoms and enhancing patient well-being.

What side effects are associated with this type of intervention?

Common treatments for fibromyalgia include medications like pregabalin and gabapentin, which are used to manage pain and improve sleep. Pregabalin can cause side effects such as dizziness, sedation, and weight gain, while gabapentin may lead to dizziness, sedation, lightheadedness, and weight gain. Both medications are generally well tolerated, but some patients may experience these adverse effects. Additionally, non-pharmacological treatments like light therapy, including GLED, are being studied for their potential to reduce pain by decreasing neuroinflammation and modulating pain pathways, with no significant adverse effects reported so far.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of fibromyalgia, including pregabalin, duloxetine, and milnacipran. Pregabalin, an anticonvulsant, helps reduce pain by modulating calcium channels and decreasing the release of neurotransmitters involved in pain pathways. Duloxetine and milnacipran are serotonin-norepinephrine reuptake inhibitors (SNRIs) that work by increasing the levels of serotonin and norepinephrine, which can help modulate pain and improve mood. These treatments, like GLED therapy, aim to modulate pain pathways, although through pharmacological rather than light-based mechanisms.

What other types of research exist?

Promising novel alternatives to GLED for fibromyalgia patients include: 1) Optogenetic approaches using TRPV1 promoter to selectively inhibit pain transmission, 2) Electroacupuncture combined with glial metabolic inhibitors like fluorocitrate to enhance analgesia, 3) High-frequency near-infrared (NIR) laser irradiation to reduce pain during orthodontic tooth movement, and 4) Red LED phototherapy, which has shown analgesic and anti-inflammatory effects in preclinical studies.

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Light Therapy

Green Light Therapy for Chronic Pain

N/A

Waitlist Available

Led By Mohab M Ibrahim, PhD., MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up [time frame: 10 - 22 weeks, depending on study arm]

Summary

This trial uses green light exposure to help reduce pain in patients with fibromyalgia and migraines. The green light likely works by decreasing brain inflammation and altering pain signals. Green light exposure has been shown to reduce headache days and improve quality of life in migraine patients without adverse events.

Who is the study for?

This trial is for adults over 18 who speak English, have been diagnosed with fibromyalgia according to specific criteria, and experience chronic pain rated at least 5 out of 10 despite medical treatment. People with serious mental illness, color blindness, uncorrected cataracts or those paid for their condition are excluded.

What is being tested?

The study tests Green Light Therapy (GLED) as a potential treatment for fibromyalgia and chronic pain. It aims to understand how GLED might reduce pain by affecting the brain's processing of pain signals. Participants will be randomly assigned to receive either GLED or a placebo in a controlled environment.

What are the potential side effects?

Previous studies suggest that Green Light Therapy does not cause adverse effects and does not impair motor performance. However, individual experiences may vary during the course of this research.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with fibromyalgia according to the latest criteria.

Select...

My average pain level is 5 or more out of 10, and treatments haven't helped.

Select...

My average pain level is 5 or more out of 10, and medications haven't helped.

Select...

I have been diagnosed with fibromyalgia according to the latest criteria.

Select...

I am 18 or older and can speak and understand English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My genetic test shows low affinity for TSPO, affecting PET scan tracer uptake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ [time frame: 10 - 22 weeks, depending on study arm]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~[time frame: 10 - 22 weeks, depending on study arm]

This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: 10 - 22 weeks, depending on study arm] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decreased activation of glial cells.

Secondary study objectives

Pain

Decreasing Central Nervous System inflammation (CNS), Increasing Endorphins.

Ascending aorta structure

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Green light-emitting diode (GLED)Experimental Treatment1 Intervention

Subjects randomized to this arm will be exposed to GLED 2 hours a day for 10 weeks

Group II: White light-emitting diode (WLED)Placebo Group1 Intervention

Subjects randomized to this arm will be exposed to WLED 2 hours a day for 10 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Green Light

2011

Completed Phase 4

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Fibromyalgia, such as Green Light Emitting Diode Exposure (GLED), work by decreasing neuroinflammation and modulating the signaling in the ascending and descending pain pathways. This is crucial for Fibromyalgia patients because neuroinflammation and dysregulated pain pathways are key contributors to their chronic pain. By targeting these mechanisms, treatments like GLED can help reduce pain intensity and improve the overall quality of life. Additionally, other treatments often focus on improving sleep, reducing fatigue, and managing comorbid conditions, which further aid in alleviating symptoms and enhancing patient well-being.

Effects of high-frequency near infrared laser irradiation on experimental tooth movement-induced pain in rats.Development and Characterization of An Injury-free Model of Functional Pain in Rats by Exposure to Red Light.Low-Intensity Photobiomodulation Decreases Neuropathic Pain in Paw Ischemia-Reperfusion and Spared Nervus Ischiadicus Injury Experimental Models.