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Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.\ud \ud Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).\ud \ud Design, Setting, and Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.\ud \ud Interventions: Implanted medical device delivering 10-kHz SCS.\ud \ud Main Outcomes and Measures: The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months.\ud \ud Results: Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P

David J DiBenedetto1,2, Kelly M Wawrzyniak1,2, Michael E Schatman1,3, Hannah Shapiro1,4, Ronald J Kulich2,51Research and Network Development, Boston PainCare, Waltham, MA, USA; 2Department of Diagnostic Sciences, Tufts School of Dental Medicine, Boston, MA, USA; 3Deparment of Public Health and Community Medicine, Tufts School of Medicine, Boston, MA, USA; 4Department of Biopsychology, Tufts University, Medford, MA, USA; 5Department of Anesthesia Critical Care and Pain Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, MA, USAObjective: To determine the average amount of time required to detect opioid aberrancy based upon varying frequencies of urine drug testing (UDT) in a community-based, tertiary care pain management center.Subjects: This study was a retrospective analysis of 513 consecutive patients enrolled in a medication management program, receiving chronic opioid therapy between January 1, 2018 and December 31, 2018.Methods: Data were extracted from medical records including age at start of the study period, sex, ethnicity, marital status, and smoking status. UDT was performed at each prescribing visit via semi-quantitative immunoassay, and at the discretion of the clinician, a sample was sent for external confirmation using gas chromatography or mass spectrometry testing to clarify questions of inconsistency with patients’ reports or prescribed medications. For purposes of the study, “opioid aberrancy” was defined through inconsistent UDT.Results: One hundred and fifteen patients (22.4%) had at least one inconsistent UDT during the study period, and 160 (2.8%) of all UDTs were inconsistent. At this rate of inconsistency, it was determined that with monthly screening, it would require up to 36 months to detect a single aberrancy, and semi-annual testing would require as long as 216 months to detect an aberrancy.Conclusions: More frequent UDT can be helpful in terms of earlier detection of opioid aberrancy. This has significant implications for helping avoid misuse, overdose, and potential diversion. Furthermore, early detection will ideally result in earlier implementation of treatment of the emotional and behavioral factors causing aberrancy. Such early intervention is more likely to be successful in terms of reducing substance misuse in a chronic pain population, providing a higher degree of patient adherence and safety, as well as producing superior overall patient outcomes. Finally, economic benefits may include substantial savings through avoidance of the necessity for drug rehabilitation and the empirically established higher costs of treating opioid misuse comorbidities.Keywords: urine drug testing, frequency, opioid safety, economic benefits

DiBenedetto DJ, Wawrzyniak KM, Schatman ME, Kulich RJ,Finkelman M. J Pain Res. 2018;11:2929–2941. On page 2931, Figure 1 was incorrect. The correct figure is included below: Read the original article