FibromyalgiaPhase 2NCT01262131
Evaluation of Magnetic Fields to Treat Fibromyalgia
A Phase 2 study testing magnetic therapy protocol A and magnetic therapy Protocol B in people with Fibromyalgia, run by pico-tesla Magnetic Therapies, LLC.
Trial summary
The purpose of this study is to see if a device called the Resonator can help to reduce pain and improve aspects of health and quality of life for people with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- magnetic therapy protocol A and magnetic therapy Protocol B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of fibromyalgia made by the study Principal Investigator (PI) according to the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia.
- Rating of current Degree of Pain on the 0-10 Numeric Pain Intensity Scale of 4 or greater.
- Subject's use of pain relief medication(s) has been stable over the past 30 days, and subject is willing and able to maintain pre-existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
- Subject's use of insomnia medication(s) has been stable over the past 30 days, and subject is willing and able to maintain this existing use of insomnia medication(s) as his or her sole insomnia relief medication(s), as needed, throughout study participation.
- Subject has been on current (or no) medication regimen, unchanged for at least 30 days prior to study enrollment, and is willing and able to maintain that regular medication regimen, unchanged, throughout study participation.
- Willing and able to refrain from use of tender point injections throughout study participation.
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- Willing and able to abstain from partaking in other/new treatments to improve fibromyalgia symptoms during study participation.
- Adequate contraceptive measures for female subjects. > 18 years of age or older.
- Male or female.
Who cannot join
- Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device, or from attending any of the scheduled study visits, or from completing any of the study measures.
- Subject suffers from co-existent chronic pain condition(s) of non-fibromyalgia origin, such as osteoarthritis, low back pain, neck pain, painful diabetic neuropathy and postherpetic neuropathic pain, that cannot be distinguished in severity and/or in type/sensation of pain from the pain originating from the subject's condition of fibromyalgia.
- Any other significant comorbidities that might impact the ability to evaluate the subject's satisfaction of the ACR 1990 Criteria for the Classification of Fibromyalgia, or for the subject to complete any of the study assessment tools.
- Tender point injections received within the prior one month.
- Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse).
- Known inflammatory rheumatic disease.
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- Epilepsy/history of seizures/taking medication for epilepsy.
- HIV and other autoimmune disorders.
- Active cancer or treatment for cancer within last 6 months.
- Active infection(s).
- History of ECT
- Uncontrolled Hypertension.
- Advanced Pulmonary Disease.
- Unstable cardiac disease.
- Prosthetics or implants comprised of ferrous metals.
- Pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
- Consumption of more than 21 alcoholic drinks per week.
- Pregnant, breast feeding, or planning pregnancy prior to end of study participation.
- Developmental disability or other cognitive impairment that would in the judgment of the PI impair adequate comprehension of the informed consent form or complete any of the study-related activities.
- Worker's compensation, receipt of disability or present/past litigation for monetary compensation pertaining to subject's fibromyalgia condition.
- Participation in other research within 30 days of study enrollment.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Fibromyalgia: Pilot Study Protocol
The purpose of this study is to see if a device called the Resonator can help to reduce pain and improve aspects of health and quality of life for people with fibromyalgia.
Read the detailed description
The purpose of this pilot study is to assess the efficacy of the Resonator device as an adjunctive therapy to reducing pain and improving aspects of health and quality of life that are relevant to individuals with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- magnetic therapy protocol A, magnetic therapy Protocol B, placebo therapy
- Keywords
- Fibromyalgia, Pain associated with Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic therapy protocol ADevice
Application of magnetic fields using the Resonator device Protocol A
magnetic therapy Protocol BDevice
Application of magnetic fields using the Resonator device Protocol B
placebo therapyDevice
Application of inactive magnetic fields using the Resonator device
| Study group | Role | What they receive |
|---|---|---|
| Resonator Protocol A | Active comparator | Not described Receives: Device: magnetic therapy protocol A |
| Resonator Protocol B | Active comparator | Application of magnetic fields using the Resonator device Protocol B Receives: Device: magnetic therapy Protocol B |
| Inactive Resonator | Placebo comparator | Not described Receives: Device: placebo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.
Minimum scale value is '0' which represents 'no pain at all' and is the best outcome.
Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome.
Measured: 2 weeks (baseline to end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jerry I Jacobson, Ph.D, D.M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262131
- Sponsor's protocol ID
- 10242-01
- Status last verified
- Jun 2011
- First submitted
- 14 Dec 2010
- Last updated
- 1 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Evaluation of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Fibromyalgia: Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT01262131
- Acronym / sponsor ID
- 10242-01
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain associated with Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 1 Jul 2011
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 see if a device called the Resonator can help to reduce pain and improve aspects of health and quality of life for people with fibromyalgia.
Detailed description
The purpose of this pilot study is to assess the efficacy of the Resonator device as an adjunctive therapy to reducing pain and improving aspects of health and quality of life that are relevant to individuals with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resonator Protocol A | Active comparator | Device: magnetic therapy protocol A |
| Resonator Protocol B | Active comparator | Device: magnetic therapy Protocol BApplication of magnetic fields using the Resonator device Protocol B |
| Inactive Resonator | Placebo comparator | Device: placebo therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current diagnosis of fibromyalgia made by the study Principal Investigator (PI) according to the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia.
- Rating of current Degree of Pain on the 0-10 Numeric Pain Intensity Scale of 4 or greater.
- Subject's use of pain relief medication(s) has been stable over the past 30 days, and subject is willing and able to maintain pre-existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
- Subject's use of insomnia medication(s) has been stable over the past 30 days, and subject is willing and able to maintain this existing use of insomnia medication(s) as his or her sole insomnia relief medication(s), as needed, throughout study participation.
- Subject has been on current (or no) medication regimen, unchanged for at least 30 days prior to study enrollment, and is willing and able to maintain that regular medication regimen, unchanged, throughout study participation.
Key exclusion criteria (21 listed)
- Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device, or from attending any of the scheduled study visits, or from completing any of the study measures.
- Subject suffers from co-existent chronic pain condition(s) of non-fibromyalgia origin, such as osteoarthritis, low back pain, neck pain, painful diabetic neuropathy and postherpetic neuropathic pain, that cannot be distinguished in severity and/or in type/sensation of pain from the pain originating from the subject's condition of fibromyalgia.
- Any other significant comorbidities that might impact the ability to evaluate the subject's satisfaction of the ACR 1990 Criteria for the Classification of Fibromyalgia, or for the subject to complete any of the study assessment tools.
- Tender point injections received within the prior one month.
- Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse).
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 |
|---|---|---|
| magnetic therapy protocol AApplication of magnetic fields using the Resonator device Protocol A | Device | Resonator Protocol A |
| magnetic therapy Protocol BApplication of magnetic fields using the Resonator device Protocol B | Device | Resonator Protocol B |
| placebo therapyApplication of inactive magnetic fields using the Resonator device | Device | Inactive Resonator |
Primary outcome
Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.
Time frame: 2 weeks (baseline to end of treatment)
Minimum scale value is '0' which represents 'no pain at all' and is the best outcome. Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jerry I Jacobson, Ph.D, D.M.D. principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing magnetic therapy protocol A and magnetic therapy Protocol B in people with Fibromyalgia, run by pico-tesla Magnetic Therapies, LLC.
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 9 inclusion and 21 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 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale. (time frame: 2 weeks (baseline to end of treatment)). 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 1 Jul 2011.