Clinical trial NCT00110565: Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women
Official title: Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Menopause
Keywords: Magnetics
Pulsed Magnetic Pad
Magnetic Field
Electromagnetic Field
Women
Pulsed Magnetic Field
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2005-05-11
Enrollment: 87
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain
Secondary outcomes:
measure: Fatigue
measure: sleep disturbances
measure: depression
measure: perceived stress
measure: stress hormones (norepinephrine and epinephrine)
measure: cortisol
measure: pro-inflammatory cytokines (IL-1, IL-6)
measure: erythrocyte sedimentation rate (ESR)
measure: C-reactive protein (CRP)
measure: functional status
measure: feasibility of study
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Cheryl M. Bourguignon, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: