Bright Light Treatment At Home To Improve Symptom Management of Fibromyalgia Syndrome

在家进行强光治疗可改善纤维肌痛综合征的症状管理

• 批准号: 9794137
• 负责人: Helen Julia Burgess
• 金额: $ 18.78万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-26 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9794137
• 关键词: Address; Affect; Aftercare; American; Amygdaloid structure; Analgesics; Antidepressive Agents; Antiepileptic Agents; Anxiety; Applications Grants; Behavior Therapy; Chronic Disease; Cognitive Therapy; Comorbidity; Data; Development; Devices; Distress; Dropout; Etiology; Exercise; Exploratory/Developmental Grant; Fatigue; Fibromyalgia; Foundations; Functional disorder; Home environment; Human Resources; Impaired cognition; Individual; Interdisciplinary Study; Internet; Intervention; Lead; Light; Link; Measures; Mediator of activation protein; Medical; Melatonin; Obstructive Sleep Apnea; Pain; Pain Clinics; Pain intensity; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Phase; Phototherapy; Pilot Projects; Placebos; Productivity; Proxy; Public Health; Quality of life; Randomized; Reporting; Research Project Grants; Risk; Risk Factors; Sample Size; Services; Severities; Sleep; Sleep Apnea Syndromes; Sleep disturbances; Source; Strategic Planning; Symptoms; Testing; Time; Unemployment; alternative treatment; base; chronic pain; chronic widespread pain; circadian; circadian pacemaker; compliance behavior; cost effective; depressive symptoms; disability; disturbance in affect; effective therapy; fibromyalgia pain; improved; improved functioning; innovation; modifiable risk; negative affect; novel; optimal treatments; pain catastrophizing; pain reduction; pain sensitivity; reduce symptoms; sex; side effect; sleep quality; symptom management; symptomatic improvement; treatment effect; treatment group; treatment strategy

ABSTRACT Fibromyalgia syndrome (FMS) is characterized by chronic widespread pain, affect/sleep disturbance, fatigue, and cognitive dysfunction. People with FMS report high distress, disability, lost productivity, and poor quality of life. FMS is estimated to affect over 6.5 million Americans and thus represents an important public health problem. A range of pharmacological agents have been tested (antidepressants, antiepileptic medications), but findings indicate only small effects with a high rate of dropout due to adverse side-effects. Cognitive behavioral therapy (CBT) and exercise have also been tested, but have only small to modest effects. Thus, there is an urgent need to develop readily available, affordable, safe, and practical adjunctive approaches to manage FMS symptoms. In this R21 Exploratory/Developmental research grant, we will examine the extent to which a morning light treatment improves function, pain intensity, and pain sensitivity in people with FMS (n=60). We will assess baseline function, pain intensity, and pain sensitivity. Subjects will then be randomized (stratified 18-29 years vs. older): to one of two treatments: 4 weeks of bright morning light (1 h/day) or 4 weeks of dim (placebo) morning light (1 h/day). Subjects will have reassessments of function, pain intensity, and pain sensitivity at mid-treatment and post-treatment. Our pilot data suggests that morning bright light treatment can meaningfully reduce FMS symptoms. In the proposed study, we will reduce subject burden and increase innovation by testing a wearable light device (bright vs. dim Re-timer®) with objective measures of treatment compliance. Aim 1 is to determine the effect of bright versus dim (placebo) morning light treatment on function, pain intensity, and pain sensitivity in individuals with FMS. We hypothesize that function, pain intensity, and pain sensitivity will improve significantly more in the bright light treatment group than in the dim (placebo) light treatment group. Aim 2 is to determine the effect of bright vs. dim (placebo) morning light treatment on potential treatment mediators: morningness-eveningness (a proxy measure of circadian timing), sleep, negative affect, pain catastrophizing, and analgesic medication use. We hypothesize that these variables will significantly improve more with bright light than dim light treatment, and changes in these potential mediators will be associated with changes in function, pain intensity, and pain sensitivity. The Exploratory Aim is to explore whether obstructive sleep apnea severity and/or subject sex moderate treatment effects. The results will provide a foundation for a well-powered R01 RCT to test if morning light (bright vs. placebo), as a non- pharmacological adjunctive treatment, can enhance existing treatments for FMS (e.g. CBT, internet-based CBT, exercise) to improve symptom management. This R21 grant application answers PA-16-008, which calls for “interdisciplinary research to decrease symptom burden in persons with chronic illness through developing and testing innovative, cost-effective, targeted interventions” and also addresses NINR's strategic plan calling for “better symptom management of chronic pain and innovative behavioral treatments applied at home”.

摘要 纤维肌痛综合征（FMS）的特征在于慢性广泛疼痛、情感/睡眠障碍、疲劳， 和认知功能障碍患有FMS的人报告了高痛苦，残疾，生产力下降和质量差。 生活据估计，FMS影响超过650万美国人，因此代表了一个重要的公共卫生问题。 问题.已经测试了一系列药物（抗抑郁药，抗癫痫药），但 调查结果表明，只有很小的影响，由于不良副作用，辍学率很高。认知行为 CBT疗法和运动也已经过测试，但只有很小到中等的效果。因此， 迫切需要开发容易获得的，负担得起的，安全和实用的方法来管理FMS 症状在这个R21探索/发展研究补助金，我们将研究在多大程度上， 晨光治疗改善FMS患者的功能、疼痛强度和疼痛敏感性（n=60）。我们 将评估基线功能、疼痛强度和疼痛敏感性。然后将受试者随机分组（分层 18-29岁与年龄更大）：两种治疗之一：4周明亮的早晨光线（1小时/天）或4周昏暗的 （安慰剂）晨光（1小时/天）。受试者将重新评估功能、疼痛强度和疼痛 治疗中期和治疗后的敏感性。我们的试验数据表明，早晨明亮的光线治疗可以 减轻FMS症状。在拟议的研究中，我们将减轻受试者的负担， 通过测试可穿戴照明设备（亮与暗Re-timer®）进行创新，并采用客观的治疗措施 合规目的1是确定明亮与昏暗（安慰剂）晨光治疗对功能的影响， 疼痛强度和疼痛敏感性。我们假设，功能，疼痛强度， 疼痛敏感性在明亮光治疗组中比在昏暗（安慰剂）光中显著改善更多 治疗组。目的2是确定明亮与昏暗（安慰剂）晨光治疗对 潜在的治疗介质：早晨-晚上（昼夜节律定时的替代测量），睡眠， 负面影响、疼痛灾难化和止痛药物的使用。我们假设这些变量将 明亮光比昏暗光治疗显著改善更多，以及这些潜在介质的变化 将与功能、疼痛强度和疼痛敏感性的变化相关。探索的目的是 探讨阻塞性睡眠呼吸暂停的严重程度和/或受试者性别是否对治疗效果有影响。结果 将为一项有效的R 01随机对照试验提供基础，以测试早晨的光线（明亮与安慰剂）是否作为非 药物治疗，可以加强现有的治疗FMS（如CBT，基于互联网的 CBT，运动），以改善症状管理。此R21赠款申请回答PA-16-008，其中要求 “跨学科研究，以减少慢性病患者的症状负担，通过发展 并测试创新的，具有成本效益的，有针对性的干预措施”，并解决NINR的战略计划呼吁 “更好的慢性疼痛症状管理和创新的行为治疗应用于家庭”。