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

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00110565

Collaborator

(none)

Enrollment

Location

29.9

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Menopause	Device: Pulsed magnetic field pad	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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