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

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

ClinicalTrials.gov Identifier:

NCT00110565

First received: May 10, 2005

Last updated: August 4, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 10, 2005

Last Updated Date

August 4, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

July 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00110565 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Rheumatoid Arthritis
Menopause

Intervention ^ICMJE

Device: Pulsed magnetic field pad

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

35 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00110565

Other Study ID Numbers ^ICMJE

R21AT001469-01A2( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Center for Complementary and Integrative Health (NCCIH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Cheryl M. Bourguignon, PhD, RN

University of Virginia

PRS Account

National Center for Complementary and Integrative Health (NCCIH)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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