PEMF Efficacy in Reducing Rheumatoid Arthritis Symptoms

描述（由申请人提供）：类风湿性关节炎（RA）是一种死亡率高、发病率高的破坏性炎症性疾病，女性多于男性。类风湿性关节炎的症状包括疼痛、疲劳、睡眠障碍和抑郁，绝经期的女性往往会变得更严重。尽管使用了非甾体抗炎药和疾病缓解抗风湿药，这些症状经常持续存在。在两项非对照研究中，类风湿关节炎患者报告使用低强度脉冲电磁场（PEMF）后疼痛和关节肿胀得到改善。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的影响程度；并对所提出的设计进行可行性测试。参与者将被随机分配到三个治疗组中的一个：积极的PEMF，假PEMF和标准治疗。活跃组和假组的女性将每天两次在垫子上躺8分钟。活跃组将在整个身体上接受低强度的PEMF。

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.