Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms

Conditions
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Menopause, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Pulsed magnetic field pad


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of RA Postmenopausal, defined by no menstrual period in at least 2 years prior to study entry or a hysterectomy Average pain of 2 or greater on a 0 to 10 pain scale Sleep difficulty Stable medication use related to RA for at least 4 weeks prior to study entry Exclusion Criteria: Diagnoses of lupus, sleep apnea, or restless leg syndrome High-dose prednisone (more than 10 mg/day) or equivalent Pacemakers or other implanted devices Epilepsy Currently undergoing treatment for cancer

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulsed magnetic field pad|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  |  | 
| sleep disturbances |  |  | 
| depression |  |  | 
| perceived stress |  |  | 
| stress hormones (norepinephrine and epinephrine) |  |  | 
| cortisol |  |  | 
| pro-inflammatory cytokines (IL-1, IL-6) |  |  | 
| erythrocyte sedimentation rate (ESR) |  |  | 
| C-reactive protein (CRP) |  |  | 
| functional status |  |  | 
| feasibility of study |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetics, Pulsed Magnetic Pad, Magnetic Field, Electromagnetic Field, Women, Pulsed Magnetic Field