title: Prospective clinical study of a new implantable peripheral nerve stimulation device to treat chronic pain.
abstract: OBJECTIVE
  To evaluate clinical use of the StimRouter, an investigational implanted peripheral nerve stimulator for treating chronic neuropathic pain, using the median nerve as a model for that general application.
  
  
  METHODS
  Eight patients with carpal tunnel syndrome and chronic pain despite both carpal tunnel release and treatment with oral pain medications were enrolled in a single-center, open-label trial after institutional review board approval. Primary endpoints were successful implantation near the target peripheral nerve and safety. All 8 patients were implanted temporarily at the median nerve in at least one arm and 2 patients were implanted bilaterally, with 10 implants total. Each implant was considered a separate "patient." For 5 days, all patients received 6 hours of daily transdermal electrical stimulation targeting the median nerve. Pain was measured at baseline, during implant, and after explant.
  
  
  RESULTS
  Two patients experienced clinically meaningful (>or=30%) pain reduction throughout the entire 5-day treatment period. Apparent carryover effect in pain reduction also was observed after daily stimulation. After explant, pain returned to baseline, increasing 36.8% to 45.6% relative to average reduced pain with daily stimulation. No significant or unexpected adverse events occurred. Mean patient study satisfaction was 96%, and 100% of patients indicated a preference for permanent implant.
  
  
  CONCLUSIONS
  Temporary implant of the StimRouter device resulted in both pain reduction and reduced use of oral opioid pain medication during the 5-day stimulation period. The results suggest that permanent implant of the StimRouter System may be safe and effective for treating chronic peripheral neuropathic pain.
authors.affiliation: The Center for Pain Relief, Inc, Charleston, WV 25301, USA. Doctdeer@aol.com
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Deer
authors.forename: Robert M
authors.initials: RM
authors.lastname: Levy
authors.forename: Evan L
authors.initials: EL
authors.lastname: Rosenfeld
mesh_terms: D000328:Adult; D000698:Analgesia / Q000379:methods*; D000701:Analgesics, Opioid / Q000627:therapeutic use; D002349:Carpal Tunnel Syndrome / Q000628:therapy*; D002908:Chronic Disease / Q000628:therapy; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D005260:Female; D006801:Humans; D008297:Male; D008475:Median Nerve; D008875:Middle Aged; D059408:Pain Management; D010147:Pain Measurement; D017060:Patient Satisfaction; D018579:Patient Selection; D011446:Prospective Studies; D019736:Prostheses and Implants; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid