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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 Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00110565
First received: May 10, 2005
Last updated: August 4, 2008
Last verified: August 2008

May 10, 2005
August 4, 2008
January 2005
July 2007   (final data collection date for primary outcome measure)
Pain
Same as current
Complete list of historical versions of study NCT00110565 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women
Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Menopause
Device: Pulsed magnetic field pad
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110565
R21 AT001469-01A2
No
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Cheryl M. Bourguignon, PhD, RN University of Virginia
National Center for Complementary and Alternative Medicine (NCCAM)
August 2008

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