Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain

NCT ID: NCT00444990

Last Updated: 2007-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-12-31

Brief Summary

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.

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.

Conditions

Low Back Pain

Keywords

Lumbar pain; magnets; Reduce low back pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Magnetic Flex Pad

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weintraub, Michael I., MD, FACP, FAAN

INDIV

Sponsor Role: lead

Principal Investigators

Michael I. Weintraub, MD

Role: PRINCIPAL_INVESTIGATOR

Phelps Memorial Hospital

Locations

Michael I. Weintraub, MD

Briarcliff Manor, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael I Weintraub, MD

Role: CONTACT

Phone: 914-941-0788

Email: miwneuro@pol.net

Susan E. Wolert

Role: CONTACT

Phone: 914-941-0788

Email: miwneuro@pol.net

Facility Contacts

Michael I Weintraub, MD

Role: primary

Susan E Wolert

Role: backup

Other Identifiers

00781441

Identifier Type: -

Identifier Source: org_study_id