Elucidating the Central Mechanism(s) of Action for Green Light Therapy in Managing Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Decreased activation of glial cells.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Green light-emitting diode (GLED)
Subjects randomized to this arm will be exposed to GLED 2 hours a day for 10 weeks
干预措施: Green Light (Device)
White light-emitting diode (WLED)
Subjects randomized to this arm will be exposed to WLED 2 hours a day for 10 weeks
干预措施: Green Light (Device)
结局指标
主要结局
Decreased activation of glial cells.
时间窗: [Time Frame: 10 - 22 weeks, depending on study arm]
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
次要结局
- Decreasing Central Nervous System inflammation (CNS), Increasing Endorphins.([Time Frame: 10 - 22 weeks, depending on study arm])
- Decreasing the activity of ascending pain pathway, and increasing the activity the descending pain pathway([Time Frame: 10 - 22 weeks, depending on study arm])
- Improvement in Fibromyalgia Impact Questionnaire score([Time Frame: 10 - 22 weeks, depending on study arm])
- Decreased objective and subjective pain scores to mechanical and thermal stimulation([Time Frame: 10 - 22 weeks, depending on study arm])
研究者
Mohab Ibrahim, PhD MD
Associate Professor, Anesthesiology
University of Arizona