The Effects of the MME Procedure on Chronic Low Back Pain

July 8, 2007 updated by: Advanced Magnetic Research Institute International

A Randomized Sham-Controlled Clinical Study to Evaluate the Effects of the Magnetic Molecular Energizer (MME)on Chronic Low Back Pain

The purpose of this study is to test whether or not the Magnetic Molecular Energizer (MME) device provides a well tolerated and effective intervention to reduce pain, pain-related symptoms and improve ability to function in those diagnosed with the condition "Chronic Low Back Pain" (chronic LBP).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pilot studies conducted by AMRI International suggest that 0.5T static magnetic field energy as supplied by the investigational device Magnetic Molecular Energizer (MME) may be effective for relieving chronic low back pain that has been persistent despite conventional therapy. This study is is a randomized, sham-controlled trial intended to show whether or not the MME intervention is an effective, well tolerated intervention for the reduction of pain, pain related symptoms and improved ability to function in those diagnosed with the condition, chronic low back pain.

The MME procedure consists of laying on a treatment bed with the individual's body positioned between two large, electromagnetic coils that create a very strong (0.3T - 0.5T) magnetic field that passes through the body. The device bears a superficial resemblance to an open MRI machine. The field is focused on the low back area. The total intervention time for the study is 140 hr of MME exposure, consisting of 8 - 12 hrs per day for 12 - 18 consecutive days or nights. Participants with be assessed prior to starting the intervention by history and physical exam conducted by one of the physician investigators, assessing pain level by using a visual analogue pain scale, assessing functional ability using the Oswestry Low Back Pain Disability Index questionnaire and assessment of cutaneous perception threshold (CPT) using the Neurometer device.

Pain scale levels will be assessed daily throughout the intervention period. At the conclusion of the intervention period, CPT testing will be repeated. One month after the intervention, the Oswestry Low Back Pain Disability Index questionnaire will be mailed to the participant. The final evaluation will be six months after the intervention. The participant is to return to the clinic and repeat CPT testing, report pain levels and complete the Oswestry Low Back Pain Disability Index questionnaire.

The targeted enrollment for the trial is 100 participants. The participants will be randomized so that 50 receive the active procedure and 50 will receive a sham procedure. The sham procedure is provided by a MME device that has been disabled so that the machine appears to turn on, but no magnetic field is produced. When the final post-intervention follow-up has been completed the participants will be informed whether they received the active or sham procedure. Those who received the sham procedure will be offered to receive the active procedure if they desire. The same evaluations will be repeated with this cross-over group, but the data will be reported separately from the main trial results.

Participants are not asked to discontinue their usual medications or treatments for their low back pain. Medication usage will be assessed to see if there is any change in usage pattern associated with the procedure.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • AMRI Arizona
    • Michigan
      • Sterling Heights, Michigan, United States, 48313
        • AMRI Michegan
    • North Carolina
      • Mocksville, North Carolina, United States, 27208
        • AMRI North Carolina
    • Ohio
      • Toledo, Ohio, United States, 43606
        • AMRI NW Ohio
    • Washington
      • Renton, Washington, United States, 98055
        • AMRI WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • daily low back pain of at least 3 months duration
  • stable neurologic status
  • prior medical work up and trial of standard medical therapy

Exclusion Criteria:

  • progressive neurologic deficits
  • neurologic deficits in the legs due to a medical condition other than the back
  • severe obesity (BMI > 34.9)
  • long acting narcotics
  • severe spinal stenosis (fixed obstruction of the spinal canal)
  • pacemakers, defibrillators, implanted medication pump, spinal cord stimulator or shrapnel
  • low back screws, rods, artificial discs or cages
  • fibromyalgia
  • pregnancy
  • an open insurance claim or pending legal claim or settlement related to the back pain, or retired on back-related disability, or receiving disability pension related to the back problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
reduction in pain
improved ability to function

Secondary Outcome Measures

Outcome Measure
tolerability to procedure
neurologic stability
reduction in pain medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Magnetic Research Institute International

Investigators

  • Study Director: Wayne R Bonlie, M.D., AMRI International
  • Study Chair: Dean R Bonlie, DDS, AMRI International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Anticipated)

January 1, 2008

Study Registration Dates

First Submitted

May 10, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (Estimate)

May 12, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2007

Last Update Submitted That Met QC Criteria

July 8, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMRI-LBP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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