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Multicenter Study Observational Study
A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study.
- Marco Rossi, Giuliano DeCarolis, Goffredo Liberatoscioli, Domenico Iemma, Paola Nosella, and Luigi F Nardi.
- UCSC Faculty of Medicine, Dept. of Anesthesia and Intensive Care Policlinico A. Gemelli, Rome, Italy.
- Pain Physician. 2016 Jan 1; 19 (1): E121-8.
BackgroundPeripheral 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.ObjectivesEvaluate the short- and long-term efficacy of a single probe and single shot PENS approach.Study DesignMulticenter, prospective, observational study.SettingFour Italian pain therapy centers.MethodsInclusion 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.PatientsSeventy-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.InterventionAfter 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.MeasurementNumerical 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.ResultsNRS 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.LimitationsSmall sample size and non-randomized observational study; high prevalence of post-herpetic and occipital neuralgias.ConclusionPENS 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.
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