Chronic Low Back PainPhase 3NCT00325377
The Effects of the MME Procedure on Chronic Low Back Pain
A Phase 3 study testing MME Procedure in people with Chronic Low Back Pain, run by Advanced Magnetic Research Institute International at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- MME Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2006to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily low back pain of at least 3 months duration
- stable neurologic status
- prior medical work up and trial of standard medical therapy
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
AMRI North Carolina
Mocksville, North Carolina, 27208
AMRI WA
Renton, Washington, 98055
AMRI Michegan
Sterling Heights, Michigan, 48313
AMRI NW Ohio
Toledo, Ohio, 43606
AMRI Arizona
Tucson, Arizona, 85711
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- MME Procedure
- Keywords
- low back pain, pain, magnetism, electromagnetic fields, visual analogue pain scale
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MME ProcedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in pain
improved ability to function
Secondary outcomes (3)
tolerability to procedure
neurologic stability
reduction in pain medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startApr 2006
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Magnetic Research Institute International
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wayne R Bonlie, M.D., Study director, AMRI InternationalDean R Bonlie, DDS, Study chair, AMRI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325377
- Sponsor's protocol ID
- AMRI-LBP-002
- Status last verified
- Jul 2007
- First submitted
- 10 May 2006
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-Controlled Clinical Study to Evaluate the Effects of the Magnetic Molecular Energizer (MME)on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00325377
- Acronym / sponsor ID
- AMRI-LBP-002
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, pain, magnetism, electromagnetic fields, visual analogue pain scale
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Advanced Magnetic Research Institute InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Jan 2008 (estimated)
- First posted
- 12 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- daily low back pain of at least 3 months duration
- stable neurologic status
- prior medical work up and trial of standard medical therapy
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MME Procedure | Procedure or surgery | – |
Primary outcome
reduction in pain
improved ability to function
3 secondary outcomes
tolerability to procedure
neurologic stability
reduction in pain medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne R Bonlie, M.D. study director
AMRI International
Dean R Bonlie, DDS study chair
AMRI International
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MME Procedure in people with Chronic Low Back Pain, run by Advanced Magnetic Research Institute International at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in pain. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2007.