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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resonator Protocol A | Active Comparator |
| |
| Resonator Protocol B | Active Comparator | Application of magnetic fields using the Resonator device Protocol B |
|
| Inactive Resonator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic therapy protocol A | Device | Application of magnetic fields using the Resonator device Protocol A |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks (baseline to end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry I Jacobson, Ph.D, D.M.D. | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Resonator Protocol A | Application of magnetic fields using the Resonator device protocol A |
| FG001 | Resonator Protocol B | Application of magnetic fields using the Resonator device treatment protocol B |
| FG002 | Inactive Resonator | Application of inactive magnetic fields using the Resonator device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Resonator Protocol A | Application of magnetic fields using the Resonator device protocol A |
| BG001 | Resonator Protocol B | Application of magnetic fields using the Resonator device treatment protocol B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was by intention to treat which included all enrolled subjects in this case to study completion. | Posted | Jun 2011 | Mean | Standard Deviation | Scores on a scale | 2 weeks (baseline to end of treatment) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resonator Protocol A | Application of magnetic fields using the Resonator device protocol A |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allen S. Braswell CEO | Pico-Tesla Magnetic Therapies, LLC | 303 795-3222 | abraswell@pico-tesla.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| magnetic therapy Protocol B | Device | Application of magnetic fields using the Resonator device Protocol B |
|
| placebo therapy | Device | Application of inactive magnetic fields using the Resonator device |
|
| BG002 | Inactive Resonator | Application of inactive magnetic fields using the Resonator device |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Application of magnetic fields using the Resonator device treatment protocol B
| OG002 | Inactive Resonator | Application of inactive magnetic fields using the Resonator device |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Resonator Protocol B | Application of magnetic fields using the Resonator device treatment protocol B | 0 | 4 | 0 | 4 |
| EG002 | Inactive Resonator | Application of inactive magnetic fields using the Resonator device | 0 | 4 | 0 | 4 |
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| D009422 |
| Nervous System Diseases |