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

Primary Purpose

Rheumatoid Arthritis, Menopause

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pulsed magnetic field pad
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Magnetics, Pulsed Magnetic Pad, Magnetic Field, Electromagnetic Field, Women, Pulsed Magnetic Field

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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 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

Sites / Locations

  • University of Virginia

Outcomes

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

Full Information

First Posted
May 10, 2005
Last Updated
August 4, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00110565
Brief Title
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Menopause
Keywords
Magnetics, Pulsed Magnetic Pad, Magnetic Field, Electromagnetic Field, Women, Pulsed Magnetic Field

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
87 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pulsed magnetic field pad
Primary Outcome Measure Information:
Title
Pain
Secondary Outcome Measure Information:
Title
Fatigue
Title
sleep disturbances
Title
depression
Title
perceived stress
Title
stress hormones (norepinephrine and epinephrine)
Title
cortisol
Title
pro-inflammatory cytokines (IL-1, IL-6)
Title
erythrocyte sedimentation rate (ESR)
Title
C-reactive protein (CRP)
Title
functional status
Title
feasibility of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl M. Bourguignon, PhD, RN
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

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

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