Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
研究概览
简要总结
The purpose of this study is to determine the effect a morning light treatment has on improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia syndrome (FMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The outcome assessors and participants were blinded to condition. The PI and lab manager remained unblinded, and performed the fidelity and side-effects assessments. Participants were asked and reminded throughout the study to only speak about their light treatment with either the PI or lab manager.
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
- •Meet criteria for Fibromyalgia syndrome (FMS)
排除标准
- •Significant chronic disease
- •Severe hearing or memory problems
- •Pending medical leave applications at workplace
- •Current pregnancy, breastfeeding, or actively trying to get pregnant
- •Night work or travel outside the eastern time zone within 1 month of the study
- •Other research participation
- •Frequent number of special events during study period (weddings, concerts, exams, etc).
结局指标
主要结局
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
时间窗: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status.
次要结局
- Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test(Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline))
- Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test(Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).)
- Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score(Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).)
研究者
Helen Burgess
Professor of Psychiatry
University of Michigan