Fibromyalgia
Conditions
Keywords
Fibromyalgia, Pain associated with Fibromyalgia
Brief 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.
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.
Interventions
DEVICEmagnetic therapy protocol A
Application of magnetic fields using the Resonator device Protocol A
DEVICEmagnetic therapy Protocol B
Application of magnetic fields using the Resonator device Protocol B
DEVICEplacebo therapy
Application of inactive magnetic fields using the Resonator device
Sponsors
pico-tesla Magnetic Therapies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale. | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Resonator Protocol A Application of magnetic fields using the Resonator device protocol A | 5 |
| Resonator Protocol B Application of magnetic fields using the Resonator device treatment protocol B | 4 |
| Inactive Resonator Application of inactive magnetic fields using the Resonator device | 4 |
| Total | 13 |
Baseline characteristics
| Characteristic | Resonator Protocol A | Resonator Protocol B | Inactive Resonator | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 2 weeks (baseline to end of treatment)
Population: Analysis was by intention to treat which included all enrolled subjects in this case to study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resonator Protocol A | Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale. | -3.69 Scores on a scale | Standard Deviation 1.2 |
| Resonator Protocol B | Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale. | -3.08 Scores on a scale | Standard Deviation 1.2 |
| Inactive Resonator | Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale. | -1.97 Scores on a scale | Standard Deviation 1 |