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The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the management of fibromyalgia. Patients who meet the 1990 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 45 fibromyalgia patients will be randomized into one of three study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the remaining two groups will receive different amounts of RINCE therapy. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-week RINCE | Active Comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device |
|
| 8-week RINCE | Active Comparator | RINCE - active RINCE therapy involving 16 total treatment applications from NeuroPoint device, followed by 8 sham applications from the NeuroPoint device |
|
| Sham RINCE | Sham Comparator | Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RINCE | Device | The intervention uses the NeuroPoint device to deliver repeat applications of RINCE therapy stimulation. The sham uses the NeuroPoint device, but the RINCE therapy stimulation is not turned on. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patient 24-hour recall average pain intensity | Pain intensity evaluated on a 100-mm visual analog scale (VAS) | Assessed at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reported Global Impression of Change | Assessed at 12 weeks | |
| Change from baseline in Revised Fibromyalgia Impact Questionnaire | Assessed at 12 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Beck Depression Inventory (BDI-II) | Assessed at 12 weeks | |
| Change from baseline in EEG measures | Various measures collected from resting electroencephalogram (EEG) | Assessed at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22233397 | Background | Hargrove JB, Bennett RM, Simons DG, Smith SJ, Nagpal S, Deering DE. A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x. | |
| 22525670 | Background | Hargrove JB, Bennett RM, Clauw DJ. Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Arch Phys Med Rehabil. 2012 Oct;93(10):1868-71. doi: 10.1016/j.apmr.2012.04.006. Epub 2012 Apr 21. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Change from baseline in patient 7-day recall average pain intensity |
Pain intensity evaluated on a 100-mm visual analog scale (VAS) |
| Assessed at 12 weeks |
| Change from baseline in Jenkins Sleep Questionnaire | Sleep measures evaluated using a 100-mm visual analog scale (VAS) | Assessed at 12 weeks |
| Change from baseline in Multiple Ability Self-Report Questionnaire (MASQ) | Assessed at 12 weeks |
| Change from baseline in Mental Clutter Scale (MCS) | Assessed at 12 weeks |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |