- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110565
Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women
Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pain
|
Secondary Outcome Measures
Outcome Measure |
---|
depression
|
Fatigue
|
C-reactive protein (CRP)
|
sleep disturbances
|
perceived stress
|
stress hormones (norepinephrine and epinephrine)
|
cortisol
|
pro-inflammatory cytokines (IL-1, IL-6)
|
erythrocyte sedimentation rate (ESR)
|
functional status
|
feasibility of study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cheryl M. Bourguignon, PhD, RN, University of Virginia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001469-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Universidad Autonoma de Nuevo LeonCompletedRheumatoId ArthritisMexico
-
Hamad Medical CorporationUnknownRHEUMATOID ARTHRITISQatar
Clinical Trials on Pulsed magnetic field pad
-
Northern Orthopaedic Division, DenmarkUnknownChronic Venous Hypertension With Ulcer and Inflammation | Venous Ulcer PainDenmark
-
Wake Forest University Health SciencesNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingInterstitial Cystitis | Bladder Pain Syndrome | Chronic Interstitial CystitisUnited States
-
Shrouk Abd Elmohsen Taha Basiony ElnhrawyCompletedJuvenile Idiopathic ArthritisEgypt
-
Auburn UniversityQuantumTX Pte LtdRecruiting
-
Wake Forest University Health SciencesCompletedInterstitial Cystitis | Bladder Pain Syndrome | Chronic Interstitial CystitisUnited States
-
Horus UniversityCompletedOsteo Arthritis Knee | Ultrasound Therapy; ComplicationsEgypt
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
Jolanta ZwolińskaCompleted
-
Mayo ClinicRecruitingMyocardial Infarction | Coronary Artery DiseaseUnited States
-
Shanghai MicroPort EP MedTech Co., Ltd.Active, not recruitingParoxysmal Supraventricular TachycardiaChina