Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110565
Status:
COMPLETED
Last Update Posted:
2008-08-06
First Post:
2005-05-10
Brief Title:
Effects of Pulsed Magnetic Pads on Rheumatoid Arthritis Symptoms in Postmenopausal Women
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Pulsed Electromagnetic Field PEMF Efficacy in Reducing Rheumatoid Arthritis Symptoms
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None