Low Back Pain Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)
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:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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