Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407615
Status:
UNKNOWN
Last Update Posted:
2007-09-21
First Post:
2006-12-01
Brief Title:
Double-Blind Placebo Study on Magnetic Field Therapy in 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
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:
None
Brief Summary:
This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar pain I understand that I will wear a flex pad magnet during waking hours and keep daily Visual Analog Scale VAS pain scores to determine if wearing this device will reduce my constant pain I understand that there are no adverse side effects known from the use of these magnets other than irritation at the site The identical inactive pads shamplacebo have been supplied for use as controls
I will be randomly assigned into one of two groups and I agree to remain blinded as to the specific type of device that I will receive ie active vs placebo Dr Weintraub principal investigator will remain blinded throughout the study I also agree to not break the blind Dr Weintraub has stated that as a result of my cooperation and ability to complete the study I will be guaranteed to either keep my specific device or receive a specific known active device gratis This currently sells commercially for 60
I will be randomly assigned into one of two groups and I agree to remain blinded as to the specific type of device that I will receive ie active vs placebo Dr Weintraub principal investigator will remain blinded throughout the study I also agree to not break the blind Dr Weintraub has stated that as a result of my cooperation and ability to complete the study I will be guaranteed to either keep my specific device or receive a specific known active device gratis This currently sells commercially for 60
Detailed Description:
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
It is my 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
SIGNIFICANCE
This is a low-cost safe and effective non-invasive treatment for musculoskeletal pain and specifically for chronic low back pain An effective outcome would reduce dependency on pharmacological interventions with attempt at reductions in known side effects
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
PARTICIPANTS
Forty 40 outpatients with chronic low back pain will be enrolled
PROTOCOL
A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
INCLUSION CRITERIA
Female or male subjects age 18-80
Capable of understanding and complying with study protocols
Chronic lumbar pain for at least six months
EXCLUSION CRITERIA
Unable to understand informed consent mental retardation psychosis communicative impairment
Cardiac pacemaker or other mechanical internal devices
Tumor in the spinehistory of malignancy or tumor
Pregnancy
Prior spine surgery
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
It is my 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
SIGNIFICANCE
This is a low-cost safe and effective non-invasive treatment for musculoskeletal pain and specifically for chronic low back pain An effective outcome would reduce dependency on pharmacological interventions with attempt at reductions in known side effects
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
PARTICIPANTS
Forty 40 outpatients with chronic low back pain will be enrolled
PROTOCOL
A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
INCLUSION CRITERIA
Female or male subjects age 18-80
Capable of understanding and complying with study protocols
Chronic lumbar pain for at least six months
EXCLUSION CRITERIA
Unable to understand informed consent mental retardation psychosis communicative impairment
Cardiac pacemaker or other mechanical internal devices
Tumor in the spinehistory of malignancy or tumor
Pregnancy
Prior spine surgery
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