The Effects of the MME Procedure on Chronic Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Advanced Magnetic Research Institute International.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Advanced Magnetic Research Institute International
ClinicalTrials.gov Identifier:
NCT00325377
First received: May 10, 2006
Last updated: July 8, 2007
Last verified: July 2007
  Purpose

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).


Condition Intervention Phase
Chronic Low Back Pain
Procedure: MME Procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Sham-Controlled Clinical Study to Evaluate the Effects of the Magnetic Molecular Energizer (MME)on Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Advanced Magnetic Research Institute International:

Primary Outcome Measures:
  • reduction in pain
  • improved ability to function

Secondary Outcome Measures:
  • tolerability to procedure
  • neurologic stability
  • reduction in pain medication

Estimated Enrollment: 100
Study Start Date: April 2006
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00325377

Locations
United States, Arizona
AMRI Arizona
Tucson, Arizona, United States, 85711
United States, Michigan
AMRI Michegan
Sterling Heights, Michigan, United States, 48313
United States, North Carolina
AMRI North Carolina
Mocksville, North Carolina, United States, 27208
United States, Ohio
AMRI NW Ohio
Toledo, Ohio, United States, 43606
United States, Washington
AMRI WA
Renton, Washington, United States, 98055
Sponsors and Collaborators
Advanced Magnetic Research Institute International
Investigators
Study Director: Wayne R Bonlie, M.D. AMRI International
Study Chair: Dean R Bonlie, DDS AMRI International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325377     History of Changes
Other Study ID Numbers: AMRI-LBP-002
Study First Received: May 10, 2006
Last Updated: July 8, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Magnetic Research Institute International:
low back pain
pain
magnetism
electromagnetic fields
visual analogue pain scale

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

ClinicalTrials.gov processed this record on August 19, 2014