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


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Rheumatoid Arthritis


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

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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 Treatment or Intervention Phase
Rheumatoid Arthritis
Menopause
 Device: Pulsed magnetic field pad
Phase II

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Pain
Secondary Outcomes: 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
Expected Total Enrollment:  87

Study start: January 2005;  Expected completion: July 2006
Last follow-up: June 2006;  Data entry closure: June 2006

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.

Eligibility

Ages Eligible for Study:  35 Years and above,  Genders Eligible for Study:  Female

Criteria

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, fibromyalgia, chronic fatigue syndrome, sleep apnea, or restless leg syndrome
  • High-dose prednisone (more than 10 mg/day) or equivalent
  • Currently undergoing hormone replacement therapy (HRT) or have stopped taking HRT less than 6 weeks prior to study entry
  • Pacemakers or other implanted devices
  • Epilepsy
  • History of or present diagnosis of cancer

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00110565

Donna R. Gelzer, RN, BSN      434-243-9934    dg2s@virginia.edu
Cheryl M. Bourguignon, PhD, RN      434-924-0082    cb2n@virginia.edu

Virginia
      University of Virginia, Charlottesville,  Virginia,  22903,  United States; Recruiting
Donna R. Gelzer, RN, BSN  434-243-9934    dg2s@virginia.edu 
Cheryl M. Bourguignon, PhD, RN  434-924-0082    cb2n@virginia.edu 
Cheryl M. Bourguignon, PhD, RN,  Principal Investigator
Ann G. Taylor, EdD, MSN, RN,  Sub-Investigator
Janet E. Lewis, MD,  Sub-Investigator
William S. Evans, MD,  Sub-Investigator
George Gillis, PhD,  Sub-Investigator

Study chairs or principal investigators

Cheryl M. Bourguignon, PhD, RN,  Principal Investigator,  University of Virginia   

More Information

Study ID Numbers:  1 R21 AT001469-01A2
Record last reviewed:  May 2005
Last Updated:  May 10, 2005
Record first received:  May 10, 2005
ClinicalTrials.gov Identifier:  NCT00110565
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005


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Page Updated: December 9, 2005
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