Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Insomnia Sleep Studies, Orthopedic, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | February 2007 |
| End Date: | December 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 Quality of Sleep and Reduction of Chronic Spine Pain (Sleep/Mag)
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
permanent/static 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
permanent/static magnetic fields has no measurable effect on neuropathic pain scores or
quality of sleep scores.
DESIGN:
This is a double-blind, randomized, placebo-controlled study which will consist of two
treatment groups. Treated subjects will receive a permanent/static 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 permanent/static 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.
Inclusion Criteria:
- Female or male subjects age 18-80.
- Capable of understanding and complying with study protocols.
- Chronic cervical, thoracic or lumbar pain for at least six months.
- Sleep difficulties and/or insomnia
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.
- Pregnancy.
- Prior spine surgery
We found this trial at
1
site
Click here to add this to my saved trials
