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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

May 10, 2006
July 8, 2007
April 2006
Not Provided
  • reduction in pain
  • improved ability to function
Same as current
Complete list of historical versions of study NCT00325377 on ClinicalTrials.gov Archive Site
  • tolerability to procedure
  • neurologic stability
  • reduction in pain medication
Same as current
Not Provided
Not Provided
 
The Effects of the MME Procedure on Chronic Low Back Pain
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Low Back Pain
Procedure: MME Procedure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2008
Not Provided

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
Both
30 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00325377
AMRI-LBP-002
No
Not Provided
Advanced Magnetic Research Institute International
Not Provided
Study Director: Wayne R Bonlie, M.D. AMRI International
Study Chair: Dean R Bonlie, DDS AMRI International
Advanced Magnetic Research Institute International
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP