Version 2.5.2.0 |
Abstract
Grant Number: 5R21AT001469-02 Project Title: PEMF Efficacy in Reducing Rheumatoid Arthritis Symptoms
PI Information: Name Title BOURGUIGNON, CHERYL M. cb2n@virginia.edu Abstract: 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.
Public Health Relevance:
This Public Health Relevance is not available.Thesaurus Terms:
alternative medicine, arthritis therapy, electromagnetic radiation, human therapy evaluation, magnetic field, rheumatoid arthritis
chronic pain, depression, fatigue, functional ability, sleep disorder
blood chemistry, clinical research, female, human subject, patient oriented research, postmenopause, questionnaire, urinalysis
Institution: UNIVERSITY OF VIRGINIA CHARLOTTESVILLE BOX 400195 CHARLOTTESVILLE, VA 229044195 Fiscal Year: 2005 Department: NONE Project Start: 15-SEP-2004 Project End: 31-JUL-2007 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1