Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (LBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444990
Recruitment Status : Unknown
Verified September 2007 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was:  Recruiting
First Posted : March 8, 2007
Last Update Posted : September 21, 2007
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN

Brief Summary:


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.


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 or disease Intervention/treatment Phase
Low Back Pain Device: Magnetic Flex Pad Phase 4

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)
Study Start Date : February 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Primary Outcome Measures :
  1. VAS Pain scores/ SF 15 Pain descriptors/ PGIF/

Secondary Outcome Measures :
  1. Autonomic nervous system functions and range of motion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female or male subjects age 18-80.
  • Capable of understanding and complying with study protocols.
  • Chronic lumbar pain for at least six months

Exclusion Criteria:

  • Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
  • Cardiac pacemaker or other mechanical internal devices.
  • Tumor in the spine/history of malignancy or tumor.
  • Pregnancy.
  • Prior spine surgery.

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 identifier (NCT number): NCT00444990

Contact: Michael I Weintraub, MD 914-941-0788
Contact: Susan E. Wolert 914-941-0788

United States, New York
Michael I. Weintraub, MD Recruiting
Briarcliff Manor, New York, United States, 10510
Contact: Michael I Weintraub, MD    914-941-0788   
Contact: Susan E Wolert    914-941-0788   
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Principal Investigator: Michael I. Weintraub, MD Phelps Memorial Hospital Identifier: NCT00444990     History of Changes
Other Study ID Numbers: 00781441
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: September 21, 2007
Last Verified: September 2007

Keywords provided by Weintraub, Michael I., MD, FACP, FAAN:
Lumbar pain
Reduce low back pain

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