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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Steven P. Cole, PhD.
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:
NCT00407615
First received: December 1, 2006
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Chronic Low Back Pain
Device: Flex Pad/Static Magnet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN

Resource links provided by NLM:


Further study details as provided by Weintraub, Michael I., MD, FACP, FAAN:

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

Estimated Enrollment: 40
Study Start Date: December 2006
Estimated Study Completion Date: October 2007
Detailed Description:

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:

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.

SIGNIFICANCE:

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.

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.

PARTICIPANTS:

Forty (40) outpatients with chronic low back pain will be enrolled.

PROTOCOL:

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic Low Back Pain

Exclusion Criteria:

  • No surgery on spine,
  • no tumor,
  • no pacemaker,
  • no pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407615

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

Locations
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.
Investigators
Study Chair: Steve P Cole, PhD Research Design Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407615     History of Changes
Other Study ID Numbers: 12106
Study First Received: December 1, 2006
Last Updated: September 20, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014