What is magnetic field energy
The effects of the MME procedure on chronic lower back pain
Pilot studies conducted by AMRI International suggest that there is static magnetic field energy of 0.5T. As supplied by the exam device, Magnetic Molecular Energizer (MME) may be effective in relieving chronic back pain that has persisted despite conventional therapy. This study is a randomized, sham-controlled study designed to determine whether or not the MME is present. Intervention is an effective, well-tolerated intervention for relieving pain related symptoms and improving functioning in the chronic back pain diagnosed with the disease.
The MME procedure consists of lying on a treatment bed with the person's body positioned between two large electromagnetic coils that create a very strong (0.3T - 0.5T) magnet field that passes through the body. The device has a superficial resemblance to an open MRI machine. The field focuses on the lower back. The total intervention time for the study is 140 hours of MME exposure, consisting of 8-12 hours per day for 12-18 consecutive days or nights. Participants must be assessed based on their medical history prior to the start of the intervention, physical examination by one of the doctor's examiners, assessment of pain level using a visual analog pain scale that assesses functionality using the Oswestry Low Back Pain Disability Index Questionnaire and Skin Perception Threshold (CPT ) using the neurometer device.
The pain scales are scored daily throughout the intervention period. At the end of the intervention period, the CPT tests are repeated. One month after the intervention, the Oswestry Low Back Pain Disability Index questionnaire is sent to the participants. The final assessment is made six months after the intervention. The participant should return to the clinic and repeat CPT tests, report pain levels, and complete Oswestry Low Back Pain Disability Index questionnaires.
The targeted registration for the study is 100 participants. Participants will be randomized so that 50 will receive the active procedure and 50 will receive a sham procedure. The mock procedure is provided by an MME device that has been disabled for the computer to turn on, but no magnetic field is generated. When the final post-intervention follow-up has finished, participants will be informed whether they received the active or sham procedure. Those who have received the bogus procedure are offered to have the active procedure if they wish. The same assessments are repeated with this crossover group. However, the data are reported separately from the main test results.
Participants are not asked to stop their usual medications or treatments because of their low levels of back pain. Medication use is assessed to determine whether the pattern of use has changed associated with the procedure.
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