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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110565
• Other study ID #: R21AT001469-01A2
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2005
• Last updated: August 4, 2008
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: August 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Menopause
• Rheumatoid Arthritis

Intervention

Device:
• Pulsed magnetic field pad

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain
Secondary	Fatigue
Secondary	sleep disturbances
Secondary	depression
Secondary	perceived stress
Secondary	stress hormones (norepinephrine and epinephrine)
Secondary	cortisol
Secondary	pro-inflammatory cytokines (IL-1, IL-6)
Secondary	erythrocyte sedimentation rate (ESR)
Secondary	C-reactive protein (CRP)
Secondary	functional status
Secondary	feasibility of study