Magnets in the Treatment of Sciatica
Low Back Pain, Sciatica
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Pain, Low Back, Radiculopathy, Electromagnetic Treatment, Back Device, Sciatica, Low Back Pain
Eligibility Criteria
INCLUSION CRITERIA: Low back pain of 3 months duration or longer present at least 5 out of 7 days a week Age between 28-80 at the start of the study Men and women of all ethnicities Signs and symptoms of lumbar radiculopathy. In this study chronic lumbar radicular signs and symptoms are defined as pain located in the lower lumbar spine corresponding to L1 and below for at least 3 months with radicular characteristics, i.e. pain described as sharp, burning, with numbness and/or tingling. Ability to understand the study measures and mentally capable to give consent to participate in the study (based on an 8th grade education level) Willingness to refrain from making changes in non-study medications taken for sciatica Patients with failed back syndrome. Pain level of at least 4/10 on average on a scale of 0 to 10 for the past month Pain not attributable to malignancy, inflammatory arthritis such as rheumatoid arthritis, or infection by previous examinations or by laboratory testing Patients' agreement to keeping a log of their pain level and documentation of compliance with wearing of back device. Patients' agreement not to make changes in pain medication type of dosing during the study. Women of reproductive age agreeing to undergo a pregnancy test at baseline. EXCLUSION CRITERIA: Patients with pacemakers Patients with mechanical heart pumps Pregnancy or breast feeding Presence of pain of greater intensity in any other location than the low back or the leg History of fibromyalgia as described by Wolfe F et al. (1990) (a minimum of 11 out of 18 points of tenderness must be present to satisfy criteria for fibromyalgia) History of spinal unstability (as defined by X-ray, CT scan or MRI of grade II spondylolisthesis or greater) Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits Unwillingness to use adequate contraception excluding oral contraceptive medications (such as barrier methods with spermicide simultaneously) for women Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease History of inflammation arthritis (rheumatoid arthritis, SLE) Presence of active cancer History of spinal infection Patients s/p spinal fusion with spinal rods over the lower lumbar spine
Sites / Locations
- National Institute of Dental And Craniofacial Research (NIDCR)