Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain (SLEEP/MAG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00445133|
Recruitment Status : Unknown
Verified September 2007 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was: Recruiting
First Posted : March 8, 2007
Last Update Posted : September 27, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Neck Pain Sleep Initiation and Maintenance Disorders||Device: Magnetic Sleep Pad||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine Pain (Sleep/Mag)|
|Study Start Date :||February 2007|
|Study Completion Date :||December 2007|
- VAS Pain scores/Pittsburgh Sleep scores/Insomnia sleep scores/SF 15 pain descriptor scores/PGIC/
- Autonomic Nerve Functions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445133
|Contact: Michael I. Weintraub, MDemail@example.com|
|Contact: Susan E Wolertfirstname.lastname@example.org|
|United States, New York|
|Dr. Michael I . Weintraub||Recruiting|
|Briarcliff Manor, New York, United States, 10510|
|Contact: Michael I Weintraub, MD 914-941-0788 email@example.com|
|Contact: Susan E Wolert 914-941-0788 firstname.lastname@example.org|
|Principal Investigator: Michael I. Weintraub, MD|
|Principal Investigator:||Michael I. Weintraub, MD||Phelps Memorial Hospital|