Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain

Low Back Pain Clinical Trial

— LBP  

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00444990
• Other study ID #: 00781441
• Status: Recruiting
• Phase: Phase 4
• First received: March 6, 2007
• Last updated: September 20, 2007
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2007
• Source: Weintraub, Michael I., MD, FACP, FAAN
• Contact: Michael I Weintraub, MD
• Phone: 914-941-0788
• Email: miwneuro[@]pol.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Device:
• Magnetic Flex Pad

Locations

Country	Name	City	State
United States	Michael I. Weintraub, MD	Briarcliff Manor	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weintraub, Michael I., MD, FACP, FAAN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Pain scores/ SF 15 Pain descriptors/ PGIF/
Secondary	Autonomic nervous system functions and range of motion