Evaluation of Magnetic Fields to Treat Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: magnetic therapy protocol A; magnetic therapy Protocol B; placebo therapy
Intervention description: Application of magnetic fields using the Resonator device Protocol A; Application of magnetic fields using the Resonator device Protocol B; Application of inactive magnetic fields using the Resonator device
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Pain associated with Fibromyalgia

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.
    

Eligibility criteria:

        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.