NCT00110565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jan 2005

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

Enrollment Period

2.5 years

First QC Date

May 10, 2005

Last Update Submit

August 4, 2008

Conditions

Rheumatoid ArthritisMenopause

Keywords

MagneticsPulsed Magnetic PadMagnetic FieldElectromagnetic FieldWomenPulsed Magnetic Field

Outcome Measures

Primary Outcomes (1)

  • Pain

Secondary Outcomes (11)

  • Fatigue

  • sleep disturbances

  • depression

  • perceived stress

  • stress hormones (norepinephrine and epinephrine)

  • +6 more secondary outcomes

Interventions

Pulsed magnetic field padDEVICE

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Cheryl M. Bourguignon, PhD, RN

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 10, 2005

First Posted

May 11, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

US(1)