Evaluation of Magnetic Fields to Treat Fibromyalgia

June 6, 2011 updated by: pico-tesla Magnetic Therapies, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Resonator Protocol A
Device: magnetic therapy protocol A
Application of magnetic fields using the Resonator device Protocol A
Active Comparator: Resonator Protocol B
Application of magnetic fields using the Resonator device Protocol B
Device: magnetic therapy Protocol B
Application of magnetic fields using the Resonator device Protocol B
Placebo Comparator: Inactive Resonator
Device: placebo therapy
Application of inactive magnetic fields using the Resonator device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 weeks (baseline to end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
pico-tesla Magnetic Therapies, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jerry I Jacobson, Ph.D, D.M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10242-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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