Low Back PainPhase 2NCT00044109
Magnets in the Treatment of Sciatica
A Phase 2 study testing Magnets in people with Low Back Pain and Sciatica, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials. We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Low Back Pain, Sciatica
- What is being tested?
- Magnets
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2006
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain of 3 months duration or longer present at least 5 out of 7 days a week
- Age between 28-80 at the start of the study
- Men and women of all ethnicities
- Signs and symptoms of lumbar radiculopathy. In this study chronic lumbar radicular signs and symptoms are defined as pain located in the lower lumbar spine corresponding to L1 and below for at least 3 months with radicular characteristics, i.e. pain described as sharp, burning, with numbness and/or tingling.
- Ability to understand the study measures and mentally capable to give consent to participate in the study (based on an 8th grade education level)
- Willingness to refrain from making changes in non-study medications taken for sciatica
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- Patients with failed back syndrome.
- Pain level of at least 4/10 on average on a scale of 0 to 10 for the past month
- Pain not attributable to malignancy, inflammatory arthritis such as rheumatoid arthritis, or infection by previous examinations or by laboratory testing
- Patients' agreement to keeping a log of their pain level and documentation of compliance with wearing of back device.
- Patients' agreement not to make changes in pain medication type of dosing during the study.
- Women of reproductive age agreeing to undergo a pregnancy test at baseline.
Who cannot join
- Patients with pacemakers
- Patients with mechanical heart pumps
- Pregnancy or breast feeding
- Presence of pain of greater intensity in any other location than the low back or the leg
- History of fibromyalgia as described by Wolfe F et al. (1990) (a minimum of 11 out of 18 points of tenderness must be present to satisfy criteria for fibromyalgia)
- History of spinal unstability (as defined by X-ray, CT scan or MRI of grade II spondylolisthesis or greater)
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- Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits
- Unwillingness to use adequate contraception excluding oral contraceptive medications (such as barrier methods with spermicide simultaneously) for women
- Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease
- History of inflammation arthritis (rheumatoid arthritis, SLE)
- Presence of active cancer
- History of spinal infection
- Patients s/p spinal fusion with spinal rods over the lower lumbar spine
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Static Magnets In The Treatment of Sciatica
Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials.
We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more.
This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.
Read the detailed description
Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials.
We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more.
This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.
- Conditions
- Low Back Pain, Sciatica
- Being tested
- Magnets
- Keywords
- Pain, Low Back, Radiculopathy, Electromagnetic Treatment, Back Device, Sciatica, Low Back Pain
- Medical subject headings
- Low Back Pain, Sciatica, Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.
Secondary outcomes (1)
Baseline and end of period 1 and 2 of Phase II: Pain symptoms, Pain level with walking, Use of pain meds, Use of other non-medication treatments, questionnaire: SF 36, Oswestry and Beck Depression, Days of disability. End of Study: Patient preference.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2002 (estimated)
- Study startAug 2002
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044109
- Sponsor's protocol ID
- 020274
- Other IDs
- 02-D-0274
- Status last verified
- Jun 2006
- First submitted
- 17 Aug 2002
- Last updated
- 26 Jun 2006
- Results posted
- No
Publications
Blank M, Soo L. Optimal frequencies for magnetic acceleration of cytochrome oxidase and Na,K-ATPase reactions. Bioelectrochemistry. 2001 Mar;53(2):171-4. doi: 10.1016/s0302-4598(00)00128-8.
PubMed 11339304
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Magnets In The Treatment of Sciatica
- ClinicalTrials.gov ID
- NCT00044109
- Acronym / sponsor ID
- 020274
- Conditions
- Low Back Pain, Sciatica
- Keywords
- Pain, Low Back, Radiculopathy, Electromagnetic Treatment, Back Device, Sciatica, Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Aug 2002
- Study completion
- Jun 2006
- First posted
- 19 Aug 2002 (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.
Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials.
We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more.
This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.
Detailed description
Despite much popularity among the public, magnetic devices used for the treatment of various musculoskeletal and neuropathic pain syndromes have been the subject of few randomized controlled trials.
We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75 who have had signs and symptoms of sciatica for 3 months or more.
This is a double-blind, randomized, placebo-control, two phase study. In the first phase, after one week baseline, subjects will be randomized to 4 different treatments in a cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine and left-right across the lumbo-sacral spine), a sham device of similar configuration and a no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes will be broken to select the magnetic device associated with the greatest amount of pain score reduction. During the second phase which will also be double-blinded, subjects will be randomized to wear the selected magnetic device and sham in a cross-over design. Each of the 2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain score in the leg. Daily pain level in the low back and the back and leg combined in addition to the patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck depression inventory.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
Key exclusion criteria (13 listed)
- Patients with pacemakers
- Patients with mechanical heart pumps
- Pregnancy or breast feeding
- Presence of pain of greater intensity in any other location than the low back or the leg
- History of fibromyalgia as described by Wolfe F et al. (1990) (a minimum of 11 out of 18 points of tenderness must be present to satisfy criteria for fibromyalgia)
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 |
|---|---|---|
| Magnets | Device | – |
Primary outcome
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.
1 secondary outcome
Baseline and end of period 1 and 2 of Phase II: Pain symptoms, Pain level with walking, Use of pain meds, Use of other non-medication treatments, questionnaire: SF 36, Oswestry and Beck Depression, Days of disability. End of Study: Patient preference.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2006.
- Background: PubMed 11339304Blank M, Soo L. Optimal frequencies for magnetic acceleration of cytochrome oxidase and Na,K-ATPase reactions. Bioelectrochemistry. 2001 Mar;53(2):171-4. doi: 10.1016/s0302-4598(00)00128-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnets in people with Low Back Pain and Sciatica, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 26 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044109, which also lists 1 linked publication.
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 26 Jun 2006.