Rheumatoid ArthritisPhase 2NCT00110565
Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women
A Phase 2 study testing Pulsed magnetic field pad in people with Rheumatoid Arthritis and Menopause, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis, Menopause
- What is being tested?
- Pulsed magnetic field pad
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Menopause
- Being tested
- Pulsed magnetic field pad
- Keywords
- Magnetics, Pulsed Magnetic Pad, Magnetic Field, Electromagnetic Field, Women, Pulsed Magnetic Field
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed magnetic field padDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Secondary outcomes (11)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 87 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cheryl M. Bourguignon, PhD, RN, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110565
- Sponsor's protocol ID
- R21AT001469-01A2
- Status last verified
- Aug 2008
- First submitted
- 10 May 2005
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Field (PEMF) Efficacy in Reducing Rheumatoid Arthritis Symptoms
- ClinicalTrials.gov ID
- NCT00110565
- Acronym / sponsor ID
- R21AT001469-01A2
- Conditions
- Rheumatoid Arthritis, Menopause
- Keywords
- Magnetics, Pulsed Magnetic Pad, Magnetic Field, Electromagnetic Field, Women, Pulsed Magnetic Field
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 11 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed magnetic field pad | Device | – |
Primary outcome
Pain
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl M. Bourguignon, PhD, RN principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulsed magnetic field pad in people with Rheumatoid Arthritis and Menopause, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.