Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility: Percent of flash surveys completed
研究概览
简要总结
Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults greater than or equal to 18 and less than or equal to
- •Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
- •Individuals who experience an average pain severity greater than 4/10 in intensity at baseline.
- •Willingness to wear a battery-operated portable ganzfeld light stimulator device for 2 hours per day at the same time each day (ideally complete the light therapy session between 5 am-10 am each morning) for 5 days.
- •Alert and oriented, and able to provide informed consent
- •Ability to read and speak English to complete validated questionnaires.
排除标准
- •Vision disorders or conditions resulting in severe vision impairment or blindness
- •Individuals with self-report of color blindness
- •Prisoner Status
- •Pregnancy
- •No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger the patient).
- •History of seizure disorder
研究组 & 干预措施
Equal energy white stimulus
Equal energy white light at 500 lux. The International Commission on Illumination (CIE) coordinates of this light are (x=y=0.33), indicating that the stimulus appears uniformly white which means that the activation of each of the three classes of photoreceptors are equivalent, thus silencing any chromatic opponency. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.
干预措施: Equal Energy White stimulation (Device)
Green light stimulus
Green light at 500 lux. Participants will view 545 nm green light delivered via a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.
干预措施: Green Light stimulation (Device)
S-cone modulating white light
The S-cone modulating light stimulus will alternate between two light conditions at 500 lux that will activate the S-cones by about 100x differentially between the two conditions while maintaining the L- an M-cones at constant activation between the two alternating conditions using 427 nm versus 545 nm light. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.
干预措施: S-cone modulating white light (Device)
结局指标
主要结局
Feasibility: Percent of flash surveys completed
时间窗: 1 week
Percent of flash surveys completed during light stimulation period. 0% is the lowest and 100% is the highest. Higher percentages indicate greater percent of flash surveys completed.
Feasibility: Percent follow-up
时间窗: 1 week
Percent follow-up for 1 week baseline visit. Follow-up greater than 70% will be considered feasible.
Feasibility: Self-reported light stimulation sessions completed
时间窗: 1 week
Self-reported light stimulation sessions completed by flash survey administered after each light stimulation session over the 5 day stimulation period. Number of sessions will be reported the minimum is 0 and the maximum is 5.
次要结局
- Change in Temporal Summation(Baseline, 1 week)
- Change in pain intensity after stimulation(Baseline, 1 week)
- Change in pressure pain threshold(Baseline, 1 week)
- Change in Conditioned Pain modulation(Baseline, 1 week)
- Change in activity measured with an accelerometer(1 week prior to baseline and 1 week during light stimulation)