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
  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 Intervention Phase
Rheumatoid Arthritis
Menopause
Device: Pulsed magnetic field pad
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Pain

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 87
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110565

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Investigators
Principal Investigator: Cheryl M. Bourguignon, PhD, RN University of Virginia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00110565     History of Changes
Other Study ID Numbers: R21 AT001469-01A2
Study First Received: May 10, 2005
Last Updated: August 4, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Magnetics
Pulsed Magnetic Pad
Magnetic Field
Electromagnetic Field
Women
Pulsed Magnetic Field

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014