Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445133
Status:
UNKNOWN
Last Update Posted:
2007-09-27
First Post:
2007-03-06
Brief Title:
Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine 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 Quality of Sleep and Reduction of Chronic Spine Pain SleepMag
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:
SLEEPMAG
Brief Summary:
HYPTHOTHESIS
The researchers hypothesize that application of active magnetic therapy vs sham utilized while individuals sleep can reduce neuropathic pain in the spine and improve the quality of sleep The null hypothesis is that treatment of subjects with spine pain with exposure to permanentstatic magnetic fields has no measurable effect on neuropathic pain scores or quality of sleep scores
The researchers hypothesize that application of active magnetic therapy vs sham utilized while individuals sleep can reduce neuropathic pain in the spine and improve the quality of sleep The null hypothesis is that treatment of subjects with spine pain with exposure to permanentstatic magnetic fields has no measurable effect on neuropathic pain scores or quality of sleep scores
Detailed Description:
DESIGN
This is a double-blind randomized placebo-controlled study which will consist of two treatment groups Treated subjects will receive a permanentstatic magnetic sleeping pad with a nominal strength of less than 1000 Gauss Control subjects will receive physically identical sleeping pad with a nominal surface field strength of 0 Gauss placebo The magnets will be contained in a standard mattress pad and subjects will sleep on the pad The primary outcome measures will be quality of sleep as well as the daily VAS scores These are subjective There will be objective assessment by the quantification of autonomic nervous system ANS strengths of the parasympathetic and sympathetic effects from this non-invasive digital study using spectral analysis Individuals will be evaluated at onset of study and at end of study to look at specifics of range of motion spasm radiculitis etc Scores will be kept on a monthly basis as well as repeat of ANS testing each month At the end of the study individuals will return all forms be reevaluated by Dr Weintraub and also will be asked questions regarding PGIC for bias etc Additionally heart rate and systolic and diastolic BP readings at rest and with challenge of standing will be recorded at baseline and each visit to determine if there is an anti-hypertensive effect from sleeping on magnetic device A reduction of 3 mm Hg improves stroke and cardiac risk by a minimum of 4 No new anti-hypertensive medications will be allowed
This is a double-blind randomized placebo-controlled study which will consist of two treatment groups Treated subjects will receive a permanentstatic magnetic sleeping pad with a nominal strength of less than 1000 Gauss Control subjects will receive physically identical sleeping pad with a nominal surface field strength of 0 Gauss placebo The magnets will be contained in a standard mattress pad and subjects will sleep on the pad The primary outcome measures will be quality of sleep as well as the daily VAS scores These are subjective There will be objective assessment by the quantification of autonomic nervous system ANS strengths of the parasympathetic and sympathetic effects from this non-invasive digital study using spectral analysis Individuals will be evaluated at onset of study and at end of study to look at specifics of range of motion spasm radiculitis etc Scores will be kept on a monthly basis as well as repeat of ANS testing each month At the end of the study individuals will return all forms be reevaluated by Dr Weintraub and also will be asked questions regarding PGIC for bias etc Additionally heart rate and systolic and diastolic BP readings at rest and with challenge of standing will be recorded at baseline and each visit to determine if there is an anti-hypertensive effect from sleeping on magnetic device A reduction of 3 mm Hg improves stroke and cardiac risk by a minimum of 4 No new anti-hypertensive medications will be allowed
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