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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 treatment of pain associated with fibromyalgia. Patients who meet the 2010 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. A second group will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A third group will receive active RINCE treatment at a higher than nominal signal amplitude level (treatment mode 2). The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' 24-hour recall average pain scores. 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 mode 1 | Active Comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 1 |
|
| 12-week RINCE mode 2 | Active Comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device at treatment mode 2 |
|
| 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 NeuroPoint device is used to deliver repeat applications of RINCE therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patients' 24-hour recall average pain intensity | The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall average pain intensity using an 11-point (0-10) numerical rating scale. | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Michael Gendreau, MD PhD | Cerephex Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | United States | ||
| Superior Research LLC |
| 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 patients' 7 day recall average pain intensity |
Average pain intensity evaluated using an 11-point (0-10) numerical rating scale. |
| Assessed at 12 weeks |
| Sacramento |
| California |
| 95825 |
| United States |
| Chicago Research Center | Chicago | Illinois | 60634 | United States |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | United States |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |