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

摘要 纤维肌痛综合征(FMS)的特征是慢性广泛性疼痛，影响/睡眠障碍，疲劳， 和认知功能障碍。患有FMS的人报告高度痛苦、残疾、生产力下降和质量差 生活。据估计，FMS影响了超过650万美国人，因此代表着一个重要的公共卫生 有问题。已经测试了一系列药理药物(抗抑郁药物、抗癫痫药物)，但 结果表明，由于不良副作用，只有很小的效果和很高的辍学率。认知行为 治疗(CBT)和锻炼也进行了测试，但只有很小到适度的效果。因此，有一个 迫切需要开发易于获得、负担得起、安全和实用的辅助方法来管理FMS 症状。在这项R21探索性/发展性研究拨款中，我们将研究 晨光治疗改善了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，受试者将被随机(分层 18-29岁VS年龄)：接受两种治疗中的一种：4周明亮的晨光(每天1小时)或4周昏暗 (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。我们的试点数据表明，早晨的强光治疗可以 有意义地减轻FMS症状。在建议的研究中，我们会减轻科目负担，增加 通过测试具有客观治疗措施的可穿戴照明设备(BIGH VS DIM RETIMER®)进行创新 合规性。第一个目标是确定晨光疗法对功能的影响。 FMS患者的疼痛强度和疼痛敏感度。我们假设功能、疼痛强度和 强光治疗组的疼痛敏感度改善程度明显高于暗光(安慰剂)治疗组 治疗组。目标2是确定强光与暗光(安慰剂)晨光治疗对患者的影响 潜在的治疗媒介：早晨-夜晚(昼夜节律的替代测量)，睡眠， 消极情绪、疼痛灾变和止痛药的使用。我们假设这些变量将 强光处理比弱光处理显著改善，并且这些潜在的调节因子的变化 将与功能、疼痛强度和疼痛敏感度的变化有关。探索性的目的是 探讨阻塞性睡眠呼吸暂停的严重程度和/或受试者性别是否适中的治疗效果。结果是 将为性能良好的R01 RCT提供基础，以测试晨光(明亮与安慰剂)，作为非 药理辅助治疗，可以增强现有的FMS治疗方法(例如，基于互联网的CBT CBT、运动)，以改善症状管理。此R21授权申请回答PA-16-008，它调用 为“跨学科研究，以减少慢性病患者的症状负担，通过 和测试创新的、具有成本效益的、有针对性的干预措施“，也满足了NINR的战略计划要求 “更好地管理慢性疼痛的症状，并在家中应用创新的行为疗法”。

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”.