Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (LBP)
|ClinicalTrials.gov Identifier: NCT00444990|
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 21, 2007
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.
The researchers 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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Magnetic Flex Pad||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)|
|Study Start Date :||February 2007|
|Study Completion Date :||December 2007|
- VAS Pain scores/ SF 15 Pain descriptors/ PGIF/
- Autonomic nervous system functions and range of motion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444990
|Contact: Michael I Weintraub, MDfirstname.lastname@example.org|
|Contact: Susan E. Wolertemail@example.com|
|United States, New York|
|Michael I. Weintraub, MD||Recruiting|
|Briarcliff Manor, New York, United States, 10510|
|Contact: Michael I Weintraub, MD 914-941-0788 firstname.lastname@example.org|
|Contact: Susan E Wolert 914-941-0788 email@example.com|
|Principal Investigator:||Michael I. Weintraub, MD||Phelps Memorial Hospital|