Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity Using Light Bulbs: A Pilot Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of participants completing follow-up visits after each intervention period
研究概览
简要总结
This pilot randomized, double-blind, crossover clinical trial will evaluate the feasibility and preliminary efficacy of chromatic (colored) light exposure for reducing pain severity and pain sensitivity in adults with fibromyalgia or chronic widespread pain and fatigue. Participants will complete daily symptom surveys throughout the study and undergo patient-reported outcome assessments and quantitative sensory testing at multiple timepoints.
Participants will be randomized to receive either S-cone stimulating chromatic light or equal-energy white light for 2 hours daily over a 7-day treatment period. Following a 1-week washout, participants will cross over to the alternate condition. Outcomes will examine feasibility, changes in pain severity, pain interference, and measures of pain sensitivity. Total study duration is approximately 35 days.
详细描述
This pilot, randomized, double-blind, crossover clinical trial is designed to evaluate the feasibility of administering a chromatic light intervention and to explore its effects on pain severity and pain sensitivity in adults with fibromyalgia or chronic widespread pain and fatigue.
Following informed consent and enrollment, baseline assessments will be performed which will include demographic and health questionnaires, validated patient-reported outcome measures, and quantitative sensory testing (QST), including assessments of conditioned pain modulation, temporal summation, and pressure pain threshold.
Participants will then be randomly assigned to one of two treatment sequences:
S-cone stimulating chromatic light during Treatment Period 1 followed by equal-energy white light during Treatment Period 2.
Equal-energy white light during Treatment Period 1 followed by S-cone stimulating chromatic light during Treatment Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adults ≥ 18 years of age.
- •Individuals who have been diagnosed with fibromyalgia or suffer from chronic widespread pain and fatigue.
- •An average pain severity ≥4 on the 0-10 NRS over the month prior to enrollment.
- •Pain symptoms present for 3 months or longer.
- •Pain must be present in 4 out of 5 body regions.
- •A score of ≥7 on the Widespread pain index (WPI) and ≥5 on the symptom severity scale (SSS), or 4-6 on the WPI and ≥9 on the SSS in the 2016 Fibromyalgia Questionnaire.
- •Willingness to adjust light levels in home environment so that the illumination (measured in lux) provided by the light bulbs is twice the ambient room illumination (also measured in lux).
- •Willingness to use study lightbulbs for 2 consecutive hours a day for 7 consecutive days according to study specifications for both conditions (total of 14 days using lightbulbs)
- •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, uveitis or cataracts.
- •Prisoner Status
- •Pregnancy
- •History of photosensitivity or sensitivity to scintillating (mildly flickering) light.
- •History of seizure disorder.
- •Individuals living in households with people who have a history of seizure disorders.
- •Analgesic treatment plan changes anticipated in the next 3 months (surgery, analgesic medication changes, injections, pain procedures, etc.).
- •Other history or condition that would, in the investigator's judgment, indicate that the individual would highly likely be non-compliant with the study or unsuitable for the study
研究组 & 干预措施
S-cone stimulating chromatic light first followed by equal-energy white light
Participants randomized to this sequence will receive S-cone stimulating chromatic light during the first treatment period, followed by equal-energy white (flickering along the L/M axis) light during the second treatment period. Each treatment period consists of 2 hours of daily light exposure for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m., delivered using programmed "TUO" light bulbs. The two treatment periods are separated by a 1-week washout period. Participants complete daily symptom surveys, patient-reported outcome measures, and quantitative sensory testing throughout the study.
干预措施: S-Cone Stimulating Chromatic Light (Device)
S-cone stimulating chromatic light first followed by equal-energy white light
Participants randomized to this sequence will receive S-cone stimulating chromatic light during the first treatment period, followed by equal-energy white (flickering along the L/M axis) light during the second treatment period. Each treatment period consists of 2 hours of daily light exposure for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m., delivered using programmed "TUO" light bulbs. The two treatment periods are separated by a 1-week washout period. Participants complete daily symptom surveys, patient-reported outcome measures, and quantitative sensory testing throughout the study.
干预措施: Equal-Energy White Light (Device)
Equal-energy white light first followed by S-cone stimulating chromatic light
Participants randomized to this sequence will receive equal-energy white light (flickering along the L/M axis) during the first treatment period, followed by S-cone stimulating chromatic light during the second treatment period. Each treatment period consists of 2 hours of daily light exposure for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m., delivered using programmed "TUO" light bulbs. The two treatment periods are separated by a 1-week washout period. Participants complete daily symptom surveys, patient-reported outcome measures, and quantitative sensory testing throughout the study.
干预措施: S-Cone Stimulating Chromatic Light (Device)
Equal-energy white light first followed by S-cone stimulating chromatic light
Participants randomized to this sequence will receive equal-energy white light (flickering along the L/M axis) during the first treatment period, followed by S-cone stimulating chromatic light during the second treatment period. Each treatment period consists of 2 hours of daily light exposure for 7 consecutive days, ideally between 5:00 a.m. and 10:00 a.m., delivered using programmed "TUO" light bulbs. The two treatment periods are separated by a 1-week washout period. Participants complete daily symptom surveys, patient-reported outcome measures, and quantitative sensory testing throughout the study.
干预措施: Equal-Energy White Light (Device)
结局指标
主要结局
Percentage of participants completing follow-up visits after each intervention period
时间窗: Throughout study participation (35 days)
Feasibility will be assessed by percentage of participants completing follow-up visits after each intervention period.
Percentage of daily flash surveys completed during the two 7-day stimulation periods
时间窗: Throughout the two 7-day stimulation periods (14 eligible survey timepoints during active treatment period)
Feasibility will be assessed by percentage of daily flash surveys completed during the two 7-day stimulation periods (14 eligible survey time points).
Percentage of prescribed light stimulation sessions completed based on participant self-report
时间窗: Throughout the two 7-day stimulation periods (14 eligible survey timepoints during active treatment period)
Feasibility will be assessed by percentage of prescribed light stimulation sessions completed based on participant self-report.
次要结局
- Pain Intensity(Baseline, post-treatment period 1 (Day 14), post-treatment period 2 (Day 28), and follow-up (Day 35))
- Pressure Pain Threshold(Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).)
- Temporal Summation(Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).)
- Conditioned Pain Modulation(Baseline, post-treatment period 1 (Day 14), and post-treatment period 2 (Day 28).)