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

NCT ID: NCT00110565

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-07-31

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.

Conditions

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Rheumatoid Arthritis Menopause

Keywords

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Magnetics Pulsed Magnetic Pad Magnetic Field Electromagnetic Field Women Pulsed Magnetic Field

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pulsed magnetic field pad

Intervention Type DEVICE

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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Cheryl M. Bourguignon, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT001469-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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