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

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:
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:
NCT00444990
First received: March 6, 2007
Last updated: September 20, 2007
Last verified: September 2007
  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 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 (Lbp)

Resource links provided by NLM:


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

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

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

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: December 2007
Detailed Description:

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
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444990

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

Locations
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   
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Investigators
Principal Investigator: Michael I. Weintraub, MD Phelps Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00444990     History of Changes
Other Study ID Numbers: 00781441
Study First Received: March 6, 2007
Last Updated: September 20, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014