Chronic Low Back PainPhase 4NCT00407615
Double-Blind Placebo Study on Magnetic Field Therapy in Chronic Lumbar Pain
A Phase 4 study testing Flex Pad/Static Magnet in people with Chronic Low Back Pain, run by Weintraub, Michael I., MD, FACP, FAAN at 2 sites in United States.
Trial summary
This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar pain. I understand that I will wear a flex pad (magnet) during waking hours and keep daily Visual Analog Scale (VAS) pain scores to determine if wearing this device will reduce my constant pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Flex Pad/Static Magnet
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2006to Oct 2007
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic Low Back Pain
Who cannot join
- No surgery on spine,
- no tumor,
- no pacemaker,
- no pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Dr. Michael I. Weintraub
Briarcliff, New York, 10510
Michael I. Weintraub, MD, 914-941-0788, miwneuro@pol.net
- Recruiting
Michael I. Weintraub MD 325 S. Highland Avenue
Briarcliff, New York, 10510
Michael I Weintraub, MD, 914-941-0788, miwneuro@pol.net
Susan Wolert, Data
About this study
Official title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar pain. I understand that I will wear a flex pad (magnet) during waking hours and keep daily Visual Analog Scale (VAS) pain scores to determine if wearing this device will reduce my constant pain. I understand that there are no adverse side effects known from the use of these magnets other than irritation at the site. The identical inactive pads (sham/placebo) have been supplied for use as controls.
I will be randomly assigned into one of two groups and I agree to remain blinded as to the specific type of device that I will receive, i.e. active vs. placebo. Dr. Weintraub (principal investigator) will remain blinded throughout the study. I also agree to not break the blind. Dr. Weintraub has stated that as a result of my cooperation and ability to complete the study, I will be guaranteed to either keep my specific device or receive a specific known "active" device gratis. This currently sells commercially for $60.
Read the detailed description
OBJECTIVE:
The objective of this study is to determine if treatment with a flex pad impregnated with static/permanent magnets that can penetrate over 70 mm may improve the quality of chronic lumbar pain with reduction of pain scores.
HYPOTHESIS:
It is my hypothesis that the application of a flex pad active magnetic therapy vs. sham if utilized daily during waking hours can reduce back pain and/or radicular pain. The null hypothesis is that treatment of subjects with chronic back pain with exposure to static/permanent magnetic fields have no measurable effect on chronic back pain scores and will be equal to the underlying placebo.
SIGNIFICANCE:
This is a low-cost, safe and effective, non-invasive treatment for musculoskeletal pain and specifically for chronic low back pain. An effective outcome would reduce dependency on pharmacological interventions with attempt at reductions in known side effects.
DESIGN:
This is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. Treated subjects will receive a static/permanent magnetic flex pad with a nominal strength of less than 1000 Gauss. Control subjects will receive physically identical flex pad without magnet with a nominal surface field strength of 0 Gauss (placebo). The magnets will be contained in a pad with a Velcro cover and subjects will wear the pad attached to their undergarments/skin during waking hours. Dr. Weintraub will examine participants initially to look for presence or absence of radiculitis, range of motion, presence of absence of spasm, etc. The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores. It is recognized that these changes are subjective in nature. Patients will maintain their VAS scores on a monthly basis and at the end of the study, individuals will return all forms and be reevaluated by Dr. Weintraub. They will be asked specific questions regarding PGIC for bias, etc.
PARTICIPANTS:
Forty (40) outpatients with chronic low back pain will be enrolled.
PROTOCOL:
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
INCLUSION CRITERIA:
- Female or male subjects age 18-80.
- Capable of understanding and complying with study protocols.
- Chronic lumbar pain for at least six months.
EXCLUSION CRITERIA:
- Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
- Cardiac pacemaker or other mechanical internal devices.
- Tumor in the spine/history of malignancy or tumor.
- Pregnancy.
- Prior spine surgery.
- Conditions
- Chronic Low Back Pain
- Being tested
- Flex Pad/Static Magnet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flex Pad/Static MagnetDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startDec 2006
- Study completionOct 2007 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Collaborators
- Steven P. Cole, PhD.
- Investigators
- Steve P Cole, PhD, Study chair, Research Design Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407615
- Sponsor's protocol ID
- 12106
- Status last verified
- Sep 2007
- First submitted
- 1 Dec 2006
- Last updated
- 21 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
- ClinicalTrials.gov ID
- NCT00407615
- Acronym / sponsor ID
- 12106
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Collaborators
- Steven P. Cole, PhD.
- Study start
- Dec 2006
- Study completion
- Oct 2007 (estimated)
- First posted
- 5 Dec 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.
This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar pain. I understand that I will wear a flex pad (magnet) during waking hours and keep daily Visual Analog Scale (VAS) pain scores to determine if wearing this device will reduce my constant pain. I understand that there are no adverse side effects known from the use of these magnets other than irritation at the site. The identical inactive pads (sham/placebo) have been supplied for use as controls.
I will be randomly assigned into one of two groups and I agree to remain blinded as to the specific type of device that I will receive, i.e. active vs. placebo. Dr. Weintraub (principal investigator) will remain blinded throughout the study. I also agree to not break the blind. Dr. Weintraub has stated that as a result of my cooperation and ability to complete the study, I will be guaranteed to either keep my specific device or receive a specific known "active" device gratis. This currently sells commercially for $60.
Detailed description
OBJECTIVE:
The objective of this study is to determine if treatment with a flex pad impregnated with static/permanent magnets that can penetrate over 70 mm may improve the quality of chronic lumbar pain with reduction of pain scores.
HYPOTHESIS:
It is my hypothesis that the application of a flex pad active magnetic therapy vs. sham if utilized daily during waking hours can reduce back pain and/or radicular pain. The null hypothesis is that treatment of subjects with chronic back pain with exposure to static/permanent magnetic fields have no measurable effect on chronic back pain scores and will be equal to the underlying placebo.
SIGNIFICANCE:
This is a low-cost, safe and effective, non-invasive treatment for musculoskeletal pain and specifically for chronic low back pain. An effective outcome would reduce dependency on pharmacological interventions with attempt at reductions in known side effects.
DESIGN:
This is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. Treated subjects will receive a static/permanent magnetic flex pad with a nominal strength of less than 1000 Gauss. Control subjects will receive physically identical flex pad without magnet with a nominal surface field strength of 0 Gauss (placebo). The magnets will be contained in a pad with a Velcro cover and subjects will wear the pad attached to their undergarments/skin during waking hours. Dr. Weintraub will examine participants initially to look for presence or absence of radiculitis, range of motion, presence of absence of spasm, etc. The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores. It is recognized that these changes are subjective in nature. Patients will maintain their VAS scores on a monthly basis and at the end of the study, individuals will return all forms and be reevaluated by Dr. Weintraub. They will be asked specific questions regarding PGIC for bias, etc.
PARTICIPANTS:
Forty (40) outpatients with chronic low back pain will be enrolled.
PROTOCOL:
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY ON MAGNETIC FIELD THERAPY TO IMPROVE CHRONIC LUMBAR PAIN
INCLUSION CRITERIA:
- Female or male subjects age 18-80.
- Capable of understanding and complying with study protocols.
- Chronic lumbar pain for at least six months.
EXCLUSION CRITERIA:
- Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
- Cardiac pacemaker or other mechanical internal devices.
- Tumor in the spine/history of malignancy or tumor.
- Pregnancy.
- Prior spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Low Back Pain
Key exclusion criteria (4 listed)
- No surgery on spine,
- no tumor,
- no pacemaker,
- no pregnancy
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 |
|---|---|---|
| Flex Pad/Static Magnet | Device | – |
Primary outcome
The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
Steve P Cole, PhD study chair
Research Design Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flex Pad/Static Magnet in people with Chronic Low Back Pain, run by Weintraub, Michael I., MD, FACP, FAAN at 2 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 1 inclusion and 4 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 21 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Michael I. Weintraub, MD (914-941-0788, miwneuro@pol.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores. 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 21 Sep 2007.