Double-Blind Placebo Study on Magnetic Field Therapy in Chronic Lumbar Pain
Recruitment status was: Recruiting
|First Submitted Date ICMJE||December 1, 2006|
|First Posted Date ICMJE||December 5, 2006|
|Last Update Posted Date||September 21, 2007|
|Start Date ICMJE||December 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00407615 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Double-Blind Placebo Study on Magnetic Field Therapy in Chronic Lumbar Pain|
|Official Title ICMJE||A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN|
This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar pain. I understand that I will wear a flex pad (magnet) during waking hours and keep daily Visual Analog Scale (VAS) pain scores to determine if wearing this device will reduce my constant pain. I understand that there are no adverse side effects known from the use of these magnets other than irritation at the site. The identical inactive pads (sham/placebo) have been supplied for use as controls.
I will be randomly assigned into one of two groups and I agree to remain blinded as to the specific type of device that I will receive, i.e. active vs. placebo. Dr. Weintraub (principal investigator) will remain blinded throughout the study. I also agree to not break the blind. Dr. Weintraub has stated that as a result of my cooperation and ability to complete the study, I will be guaranteed to either keep my specific device or receive a specific known "active" device gratis. This currently sells commercially for $60.
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.
It is my 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.
This is a low-cost, safe and effective, non-invasive treatment for musculoskeletal pain and specifically for chronic low back pain. An effective outcome would reduce dependency on pharmacological interventions with attempt at reductions in known side effects.
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.
Forty (40) outpatients with chronic low back pain will be enrolled.
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Chronic Low Back Pain|
|Intervention ICMJE||Device: Flex Pad/Static Magnet|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||40|
|Estimated Completion Date||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00407615|
|Other Study ID Numbers ICMJE||12106|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Weintraub, Michael I., MD, FACP, FAAN|
|Collaborators ICMJE||Steven P. Cole, PhD.|
|PRS Account||Weintraub, Michael I., MD, FACP, FAAN|
|Verification Date||September 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP