Double-Blind Placebo Study on Magnetic Field Therapy in Chronic Lumbar Pain
| Status: | Completed |
|---|---|
| Conditions: | Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | December 2006 |
| End Date: | October 2007 |
| Contact: | Michael I. Weintraub, MD |
| Email: | miwneuro@pol.net |
| Phone: | 914-941-0788 |
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
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 (sham/placebo)
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, i.e. 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.
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 (sham/placebo)
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, i.e. 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.
OBJECTIVE:
The objective of this study is to determine if treatment with a flex pad impregnated with
static/permanent 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 and/or radicular pain. The null
hypothesis is that treatment of subjects with chronic back pain with exposure to
static/permanent 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 static/permanent 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 undergarments/skin 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 spine/history of malignancy or tumor.
- Pregnancy.
- Prior spine surgery.
The objective of this study is to determine if treatment with a flex pad impregnated with
static/permanent 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 and/or radicular pain. The null
hypothesis is that treatment of subjects with chronic back pain with exposure to
static/permanent 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 static/permanent 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 undergarments/skin 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 spine/history of malignancy or tumor.
- Pregnancy.
- Prior spine surgery.
Inclusion Criteria:
- Chronic Low Back Pain
Exclusion Criteria:
- No surgery on spine,
- no tumor,
- no pacemaker,
- no pregnancy
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