PEMF Efficacy in Reducing Rheumatoid Arthritis Symptoms

描述（由申请人提供）：类风湿性关节炎（RA）是一种破坏性炎症性疾病，死亡率和发病率较高，女性多于男性。RA的疼痛，疲劳，睡眠障碍和抑郁症状往往会在绝经期变得更糟。尽管使用了非甾体类抗炎药和改善疾病的抗风湿药，这些症状经常持续存在。在两项非对照研究中，RA患者报告使用低强度脉冲电磁场（PEMF）后疼痛和关节肿胀有所改善。因此，这项修订的探索性研究的具体目的是调查低强度PEMF对减少绝经后RA女性疼痛、疲劳、睡眠障碍和抑郁症状以及生理因素的影响程度;并测试拟议设计的可行性。参与者将被随机分配到三个治疗组之一：主动PEMF，假PEMF和标准治疗。积极和假PEMF组的女性将躺在垫子上8分钟，每天两次。活动组将在整个身体上接收低强度PEMF。 除了不输送PEMF外，假焊盘的外观和功能与有源焊盘相同。所有受试者将继续服用RA药物。将在基线和12周治疗期间收集数据。参与者将记录基线、第1-8周和第12周期间24小时内的疼痛、疲劳、睡眠、抑郁、炎性疾病活动、感知压力和功能状态的数据。在基线、第6周和第12周，参与者将进行以下客观测量：使用腕动记录仪的睡眠障碍;使用血清和隔夜尿的神经内分泌/ANS因子（去甲肾上腺素、肾上腺素和皮质醇）;炎症相关测量（IL-1 β、IL-6、红细胞沉降率、C反应蛋白和风湿病学家关节计数）。积极和假PEMF组的妇女也将记录他们的日常干预使用。将使用描述性统计和混合效应模型进行目的分析。

DESCRIPTION (provided by applicant): Rheumatoid arthritis (RA) is a destructive inflammatory disease with increased mortality and high morbidity, affecting more women than men. The RA symptoms of pain, fatigue, sleep disturbances, and depression often become worse for women during menopause. These symptoms frequently persist in spite of the use of non-steroidal anti-inflammatory drugs and disease modifying anti-rheumatic drugs. In two uncontrolled studies, persons with RA reported improvements in pain and joint swelling after using low strength pulsed electromagnetic fields (PEMF). Thus, the specific aims of this revised exploratory study are to investigate the magnitude of effects of low strength PEMF on reducing the symptoms of pain, fatigue, sleep disturbances, and depression as well as physiologic factors in postmenopausal women with RA; and to test the feasibility of the proposed design. Participants will be randomly assigned to one of three treatment groups: active PEMF, sham PEMF, and standard care. Women in the active and sham PEMF groups will lie on a pad for 8 minutes twice a day. The active group will receive low strength PEMF over the entire body. The sham pad will look and function identically to the active pad, except that no PEMF will be delivered. All participants will remain on their RA medications. Data will be collected at baseline and during the 12 week treatment period. Participants will record data on pain, fatigue, sleep, depression, inflammatory disease activity, perceived stress, and functional status over one 24-hour period during baseline, weeks 1-8, and week 12. At baseline, 6, and 12 weeks, participants will have objective measurements of: sleep disturbances using wrist actigraphy; neuroendocrine/ANS factors (norepinephrine, epinephrine, and cortisol) using both serum and overnight urines; inflammation related measures (IL-1 beta, IL-6, erythrocyte sedimentation rate, C-reactive protein, and rheumatologist joint counts). Women in the active and sham PEMF groups will also record their daily intervention use. Descriptive statistics and mixed effects models will be used to conduct the analysis of the aims.