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Sponsored by: |
Advanced Magnetic Research Institute International |
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Information provided by: | Advanced Magnetic Research Institute International |
ClinicalTrials.gov Identifier: | NCT00325377 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Sham-Controlled Clinical Study to Evaluate the Effects of the Magnetic Molecular Energizer (MME)on Chronic Low Back Pain |
Estimated Enrollment: | 100 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | January 2008 |
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.
Ages Eligible for Study: | 30 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Wayne R Bonlie, M.D. | AMRI International |
Study Chair: | Dean R Bonlie, DDS | AMRI International |
Study ID Numbers: | AMRI-LBP-002 |
Study First Received: | May 10, 2006 |
Last Updated: | July 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00325377 History of Changes |
Health Authority: | United States: Food and Drug Administration |
low back pain pain magnetism electromagnetic fields visual analogue pain scale |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |