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| Sponsored by: |
Weintraub, Michael I., MD, FACP, FAAN |
|---|---|
| Information provided by: | Weintraub, Michael I., MD, FACP, FAAN |
| ClinicalTrials.gov Identifier: | NCT00444990 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Device: Magnetic Flex Pad |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp) |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael I Weintraub, MD | 914-941-0788 | miwneuro@pol.net |
| Contact: Susan E. Wolert | 914-941-0788 | miwneuro@pol.net |
| United States, New York | |
| Michael I. Weintraub, MD | Recruiting |
| Briarcliff Manor, New York, United States, 10510 | |
| Contact: Michael I Weintraub, MD 914-941-0788 miwneuro@pol.net | |
| Contact: Susan E Wolert 914-941-0788 miwneuro@pol.net | |
| Principal Investigator: | Michael I. Weintraub, MD | Phelps Memorial Hospital |
More Information
| Study ID Numbers: | 00781441 |
| Study First Received: | March 6, 2007 |
| Last Updated: | September 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00444990 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lumbar pain magnets Reduce low back pain |
|
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
|
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |
