Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444990
Status:
UNKNOWN
Last Update Posted:
2007-09-21
First Post:
2007-03-06
Brief Title:
Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain
Sponsor:
Weintraub Michael I MD FACP FAAN
Organization:
Weintraub Michael I MD FACP FAAN
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain Lbp
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
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:
LBP
Brief Summary:
OBJECTIVE
The objective of this study is to determine if treatment with a flex pad impregnated with staticpermanent magnets that can penetrate over 70 mm may improve the quality of chronic lumbar pain with reduction of pain scores
HYPOTHESIS
The researchers hypothesis that the application of a flex pad active magnetic therapy vs sham if utilized daily during waking hours can reduce back pain andor radicular pain The null hypothesis is that treatment of subjects with chronic back pain with exposure to staticpermanent magnetic fields have no measurable effect on chronic back pain scores and will be equal to the underlying placebo
The objective of this study is to determine if treatment with a flex pad impregnated with staticpermanent magnets that can penetrate over 70 mm may improve the quality of chronic lumbar pain with reduction of pain scores
HYPOTHESIS
The researchers hypothesis that the application of a flex pad active magnetic therapy vs sham if utilized daily during waking hours can reduce back pain andor radicular pain The null hypothesis is that treatment of subjects with chronic back pain with exposure to staticpermanent magnetic fields have no measurable effect on chronic back pain scores and will be equal to the underlying placebo
Detailed Description:
DESIGN
This is a double-blind randomized placebo-controlled study which will consist of two treatment groups Treated subjects will receive a staticpermanent magnetic flex pad with a nominal strength of less than 1000 Gauss Control subjects will receive physically identical flex pad without magnet with a nominal surface field strength of 0 Gauss placebo The magnets will be contained in a pad with a Velcro cover and subjects will wear the pad attached to their undergarmentsskin during waking hours Dr Weintraub will examine participants initially to look for presence or absence of radiculitis range of motion presence of absence of spasm etc The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores It is recognized that these changes are subjective in nature Patients will maintain their VAS scores on a monthly basis and at the end of the study individuals will return all forms and be reevaluated by Dr Weintraub They will be asked specific questions regarding PGIC for bias etc
This is a double-blind randomized placebo-controlled study which will consist of two treatment groups Treated subjects will receive a staticpermanent magnetic flex pad with a nominal strength of less than 1000 Gauss Control subjects will receive physically identical flex pad without magnet with a nominal surface field strength of 0 Gauss placebo The magnets will be contained in a pad with a Velcro cover and subjects will wear the pad attached to their undergarmentsskin during waking hours Dr Weintraub will examine participants initially to look for presence or absence of radiculitis range of motion presence of absence of spasm etc The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores It is recognized that these changes are subjective in nature Patients will maintain their VAS scores on a monthly basis and at the end of the study individuals will return all forms and be reevaluated by Dr Weintraub They will be asked specific questions regarding PGIC for bias etc
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