title: Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study.
abstract: Test a miniaturized neurostimulator transforaminally placed at the dorsal root ganglion (DRG) and evaluate the device's safety and efficacy in treating failed back surgery syndrome (FBSS) low back pain.
  
  
  
  Pilot, two-phase study.
  
  
  
  Eleven subjects with chronic intractable neuropathic trunk and/or lower limbs pain were included.
  
  
  
  The system consisted of an implantable, miniaturized stimulator, provided by Stimwave Technologies (Freedom-4) and an external transmitter. Only one stimulator per subject was implanted unilaterally and transforaminally at L1 to L5 levels. During Phase 1 of the study, the stimulators were not anchored. In Phase 2, the stimulators were anchored. Subjects were treated during 45 days after which the stimulator was removed. Pain reduction, implant duration, and stimulator migration were registered.
  
  
  
  Overall pain reduction was 59.9%, with only one device placed at one location, covering only a portion of the painful areas in the majority of the subjects. In Phase 1, the non-anchored stimulators migrated a mean of 8.80 mm and in Phase 2 a mean of 1.83 mm. Stimulator migration did not correlate with changes in pain relief. Mean time-to-implant duration was 10 minutes and no adverse events were reported during implant, follow-up period, or after explant.
  
  
  
  The pain reduction results indicate that the Freedom-4 spinal cord stimulation (SCS) Wireless System is a viable treatment of low back pain through stimulation of the DRG, and better overall pain reduction may be achieved by implanting multiple devices. With short percutaneous implant times and excellent safety profile, this new system may offer health cost savings.
authors.affiliation: *Dallas Neurosurgical & Spine Associates, Texas Health Presbyterian Hospital, Dallas, Texas.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Weiner
authors.affiliation: Desert Institute for Spine Care, Phoenix, Arizona.
authors.forename: Anthony
authors.initials: A
authors.lastname: Yeung
authors.affiliation: Star Medica Hospital, Juárez, Chihuahua, Mexico.
authors.forename: Carlos
authors.initials: C
authors.lastname: Montes Garcia
authors.affiliation: Stimwave Technologies, Inc., Fort Lauderdale, Florida, USA laura@stimwave.com.
authors.forename: Laura
authors.initials: L
authors.lastname: Tyler Perryman
authors.affiliation: Stimwave Technologies, Inc., Fort Lauderdale, Florida, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Speck
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D055111:Failed Back Surgery Syndrome / Q000175:diagnosis / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005727:Ganglia, Spinal / Q000502:physiology*; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000295:instrumentation / Q000379:methods*; D010147:Pain Measurement / Q000295:instrumentation / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D062187:Spinal Cord Stimulation / Q000379:methods*; D016896:Treatment Outcome
keywords: Cost Effectiveness; DRG Stimulation; Low Back Pain; Miniaturized Neurostimulator; Transforaminal; Wireless SCS