title: A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study.
abstract: BACKGROUND
  Peripheral neuromodulation is often used as chronic neuropathic pain treatment. Percutaneous electrical nerve stimulation (PENS) is generally utilized with several probes at the same time and repeated treatments.
  
  
  OBJECTIVE
  Evaluate the short- and long-term efficacy of a single probe and single shot PENS approach.
  
  
  METHODS
  Multicenter, prospective, observational study.
  
  
  METHODS
  Four Italian pain therapy centers.
  
  
  METHODS
  Inclusion criteria were age = 18 and = 80 years, presence of severe peripheral neuropathic pain lasting more than 3 months, localized and refractory to pharmacological therapies. Patients with infection, coagulopathies, psychiatric disorders, pacemakers, or implantable cardiac defibrillators were excluded.
  
  
  METHODS
  Seventy-six patients (47 women, 29 men), mean age 62 ± 14 years, affected by neuralgia (21 herpes zoster infection, 31 causalgia, 24 postoperative pain) were enrolled in the study.
  
  
  METHODS
  After localization of trigger point and/or allodynic/hyperalgesic area, PENS therapy was achieved with a single 21 gauge conductive probe tunneled percutaneously and a neurostimulator device.
  
  
  METHODS
  Numerical Rating Scale (NRS) and Neuropathic Pain Scale (NPS) were assessed at baseline, 60 minutes after PENS, at one week, after one, 3, and 6 months; perceived health outcome was measured with Euroqol-5 dimension (EQ-5D) questionnaire at baseline and at 6 months. Adverse events and patient satisfaction were reported.
  
  
  RESULTS
  NRS and NPS decreased significantly after 60 minutes and the reduction remained constant over time at follow-up. EQ-5D increased significantly with respect to the baseline. Two nonclinically significant adverse events (one contralateral dysestesia and one self-resolving hematoma) were observed.
  
  
  CONCLUSIONS
  Small sample size and non-randomized observational study; high prevalence of post-herpetic and occipital neuralgias.
  
  
  CONCLUSIONS
  PENS therapy produced significant and long-lasting pain relief in chronic peripheral neuropathic pains of different etiology. The present study confirms the feasibility, safety, and repeatability of this minimally invasive technique.
authors.affiliation: UCSC Faculty of Medicine, Dept. of Anesthesia and Intensive Care Policlinico A. Gemelli, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Rossi
authors.affiliation: Azienda Ospedaliera Universitaria, Pisana, Pisa, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: DeCarolis
authors.affiliation: U.O.S.D. Centro di Fisiopatolo e Tarapia del Dolore-Ospedale SS. Annunziata Chieti, Italy.
authors.forename: Goffredo
authors.initials: G
authors.lastname: Liberatoscioli
authors.affiliation: Department of Anesthesia, Azienda Ospedialiera Universitaria Senese, Siena, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Iemma
authors.forename: Paola
authors.initials: P
authors.lastname: Nosella
authors.affiliation: U.O. di Terapia del Dolore Macerata Hospital AV3 ASUR Marche, Macerata, Italy.
authors.forename: Luigi F
authors.initials: LF
authors.lastname: Nardi
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006562:Herpes Zoster / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D006801:Humans; D006930:Hyperalgesia / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000379:methods; D010149:Postoperative Pain / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D017060:Patient Satisfaction; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome