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OpenTrials
Completed

NCT Number: NCT00110565

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

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.

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Key information

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed magnetic field pad

Device

Primary outcomes

  1. Pain

Secondary outcomes

  1. Fatigue

  2. sleep disturbances

  3. depression

  4. perceived stress

  5. stress hormones (norepinephrine and epinephrine)

  6. cortisol

  7. pro-inflammatory cytokines (IL-1, IL-6)

  8. erythrocyte sedimentation rate (ESR)

  9. C-reactive protein (CRP)

  10. functional status

  11. feasibility of study

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 11, 2005
Registry last updated
Aug 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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