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Double-Blind Placebo Study on Magnetic Field Therapy in Chronic Lumbar Pain

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ClinicalTrials.gov Identifier: NCT00407615
Recruitment Status : Unknown
Verified September 2007 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was:  Recruiting
First Posted : December 5, 2006
Last Update Posted : September 21, 2007
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Flex Pad/Static Magnet Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2006
Estimated Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Chronic Low Back Pain

Exclusion Criteria:

  • No surgery on spine,
  • no tumor,
  • no pacemaker,
  • no pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407615

Contact: Michael I. Weintraub, MD 914-941-0788 miwneuro@pol.net

United States, New York
Dr. Michael I. Weintraub Recruiting
Briarcliff, New York, United States, 10510
Contact: Michael I. Weintraub, MD    914-941-0788    miwneuro@pol.net   
Michael I. Weintraub MD 325 S. Highland Avenue Recruiting
Briarcliff, New York, United States, 10510
Contact: Michael I Weintraub, MD    914-941-0788    miwneuro@pol.net   
Sub-Investigator: Susan Wolert, Data         
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Steven P. Cole, PhD.
Study Chair: Steve P Cole, PhD Research Design Inc.
More Information

ClinicalTrials.gov Identifier: NCT00407615     History of Changes
Other Study ID Numbers: 12106
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: September 21, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms