PEMF Efficacy in Reducing Rheumatoid Arthritis Symptoms

描述(申请人提供)：类风湿性关节炎(RA)是一种破坏性的炎症性疾病，死亡率和发病率都较高，女性患者比男性更多。更年期妇女的RA疼痛、疲劳、睡眠障碍和抑郁症状通常会变得更严重。尽管使用了非类固醇消炎药和抗风湿药物，这些症状仍然经常存在。在两项非对照研究中，RA患者报告在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在减轻绝经后RA妇女疼痛、疲劳、睡眠障碍和抑郁症状以及生理因素方面的效果；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中的一个：积极的PEMF、假的PEMF和标准护理。活动组和假PEMF组的女性每天两次在垫子上躺8分钟。活动组将在全身接受低强度的PEMF。 假衬垫的外观和功能与活动衬垫相同，不同之处在于不会提供PEMF。所有参与者将继续服用RA药物。数据将在基线和12周的治疗期内收集。参与者将在基线、1-8周和12周期间的一个24小时内记录疼痛、疲劳、睡眠、抑郁、炎症活动、感觉到的压力和功能状态的数据。在基线、6周和12周，参与者将使用腕部活动记录仪对睡眠障碍进行客观测量；使用血清和夜间尿液测量神经内分泌/ANS因子(去甲肾上腺素、肾上腺素和皮质醇)；炎症相关测量(IL-1β、IL-6、红细胞沉降率、C反应蛋白和风湿病医生关节计数)。积极和虚假的PEMF组的女性也将记录她们每天的干预使用情况。将使用描述性统计和混合效应模型对目标进行分析。

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.