Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women
|ClinicalTrials.gov Identifier: NCT00110565|
Recruitment Status : Completed
First Posted : May 11, 2005
Last Update Posted : August 6, 2008
The purpose of this study is to determine whether a pulsed magnetic field (PMF) pad will improve symptoms of rheumatoid arthritis (RA) in postmenopausal women.
Study hypothesis: A pulsed magnetic field pad will effectively reduce the symptoms of RA in postmenopausal women.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Menopause||Device: Pulsed magnetic field pad||Phase 2|
RA is a condition characterized by pain, fatigue, sleep disturbances, and mood changes. These symptoms often persist despite the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying antirheumatic drugs (DMARDs). Many women for whom these drugs do not work turn to complementary and alternative therapies, including the use of magnetic devices. Although few studies have investigated the effects of low strength PMF pads in persons with RA, evidence suggests that PMF may help relieve pain, inflammation, and fatigue. This study will determine the effects of a PMF device on RA symptoms in postmenopausal women.
This study will last 12 weeks. Participants will be randomly assigned to one of three groups: active PMF pad treatment, sham PMF pad treatment, or standard of care, which may include drug therapy or physical therapy. Participants in the active and sham PMF pad groups will be treated with their assigned pad for approximately 8 minutes, twice a day for the duration of the study. Questionnaires and self-report scales will be used to assess pain, fatigue, sleep quality, mood, and inflammation episodes. Blood and urine collection will occur to assess levels of stress hormones and certain proteins.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- sleep disturbances
- perceived stress
- stress hormones (norepinephrine and epinephrine)
- pro-inflammatory cytokines (IL-1, IL-6)
- erythrocyte sedimentation rate (ESR)
- C-reactive protein (CRP)
- functional status
- feasibility of study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110565
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Cheryl M. Bourguignon, PhD, RN||University of Virginia|