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 200 fibromyalgia patients will be randomized into one of two study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the other group will receive active RINCE treatment. The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' weekly worst pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
236
The NeuroPoint device is used to deliver repeat applications of RINCE therapy
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Premier Research
Phoenix, Arizona, United States
Neurovations
Napa, California, United States
Superior Research LLC
Sacramento, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Avail Clinical Research
DeLand, Florida, United States
Compass Research LLC
Orlando, Florida, United States
Chicago Research Center
Chicago, Illinois, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Fieve Clinical Research
New York, New York, United States
...and 6 more locations
Change from baseline in patients' 24-hour recall worst 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 worst pain intensity using an 11-point (0-10) numerical rating scale.
Time frame: Assessed at 12 weeks
Patient self-reported Global Impression of Change
Time frame: Assessed at 12 weeks
Proportion of patients in the treatment and sham groups whose average daily worst pain intensity decreased by at least 50%
Worst pain intensity evaluated using an 11-point (0-10) numerical rating scale.
Time frame: Assessed at 12 weeks
Change from baseline in Revised Fibromyalgia Impact Questionnaire
Time frame: Assessed at 12 weeks
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