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

Tracking Information
First Submitted Date ICMJE	May 10, 2005
First Posted Date ICMJE	May 11, 2005
Last Update Posted Date	August 6, 2008
Study Start Date ICMJE	January 2005
Actual Primary Completion Date	July 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	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; (submitted: June 23, 2005)	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; (submitted: June 23, 2005)	87
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2007
Actual 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, Older Adult)
Accepts Healthy Volunteers	No
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	No
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