title: Prospective, Multicenter, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Novel Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin.
abstract: BACKGROUND
  Currently available central nervous system treatment strategies are often insufficient in management of peripheral neuropathic pain, prompting a resurgence of neuromodulation focused on peripheral pain. A new peripheral nerve stimulation device was investigated in a prospective, randomized, double blind, crossover study, looking specifically at efficacy and safety, with Food and Drug Administration oversight.
  
  
  METHODS
  Prospective, multicenter, randomized, double-blind, partial crossover study to assess safety and efficacy. After IRB approval, patients were enrolled, implanted, and then followed for three months to assess efficacy and one year for safety based on Food and Drug Administration guidance.
  
  
  RESULTS
  One hundred forty-seven patients were consented and screened for the study. Thirty-five did not meet inclusion or exclusion criteria. Ninety-four patients were implanted and then randomized to the treatment (45) or the Control group (49). The primary efficacy endpoint, three months after randomization to treatment, demonstrated that patients receiving active stimulation achieved a statistically significantly higher response rate of 38% vs. the 10% rate found in the Control group (p = 0.0048). Improvement in pain was statistically significant between the randomized groups, with the Treatment group achieving a mean pain reduction of 27.2% from Baseline to Month 3 compared to a 2.3% reduction in the Control group (p < 0.0001). During the partial crossover period, patients again demonstrated statistically significant improvement in pain relief with active stimulation compared to baseline. Further, the Treatment group had significantly better improvement than the Control group in secondary measures including but not limited to quality of life and satisfaction. Safety, assessed throughout the trial and with follow-up to one year, demonstrated no serious adverse events related to the device. All device-related adverse events were minor and self-limiting.
  
  
  CONCLUSIONS
  The novel peripheral nerve stimulation device is a safe and effective treatment strategy to address neuropathic pain of peripheral nerve origin.
authors.affiliation: The Center for Pain Relief, Charleston, WV, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Deer
authors.affiliation: Summit Pain Alliance, Santa Rosa, CA, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Pope
authors.affiliation: University of Illinois, Urbana-Champaign, IL, USA.
authors.forename: Ramsin
authors.initials: R
authors.lastname: Benyamin
authors.affiliation: Millennium Pain Center, Bloomington, IL, USA.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Vallejo
authors.affiliation: Virginia Mason Medical Center, Seattle, WA, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Friedman
authors.affiliation: St. Mary's Regional Medical Center, Huntington, WV, USA.
authors.forename: David
authors.initials: D
authors.lastname: Caraway
authors.affiliation: Johns Hopkins University, Premier Pain Centers, Shrewsbury, NJ, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Staats
authors.affiliation: Neurovations, Napa Valley, CA, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Grigsby
authors.affiliation: Holy Cross Hospital, Ft. Lauderdale, FL, USA.
authors.forename: W
authors.initials: W
authors.lastname: Porter McRoberts
authors.affiliation: Arizona Pain Specialists, Phoenix, AZ, USA.
authors.forename: Tory
authors.initials: T
authors.lastname: McJunkin
authors.affiliation: Casa Colina NeuroTherapeutics, Pasadena, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Shubin
authors.affiliation: Nuvo Spine and Sports Institute, Santa Monica, CA, USA.
authors.forename: Payam
authors.initials: P
authors.lastname: Vahedifar
authors.affiliation: University of Florida Health, Jacksonville, FL, USA.
authors.forename: Daryoush
authors.initials: D
authors.lastname: Tavanaiepour
authors.affiliation: Marcus Neuroscience Institute, Boca Raton, FL, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Levy
authors.affiliation: Carolinas Pain Institute at Brookstone, Wake Forest Baptist Health Care System, Winston-Salem, NC, USA.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Kapural
authors.affiliation: Cleveland Clinic Foundation, Pain Management, Cleveland, OH, USA.
authors.forename: Nagy
authors.initials: N
authors.lastname: Mekhail
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004558:Electric Stimulation / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009443:Neuritis / Q000628:therapy*; D010525:Peripheral Nerves / Q000502:physiology*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Bioness; StimRouter; chronic pain; peripheral nerve; study