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Intrathecal therapy has been limited by non-randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of intrathecal polyanalgesic consensus guidelines exist.After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator's discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey.Seventy-nine patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroups within the CMM for chronic pain-related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from the baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications.This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

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Background and aims: PDN can lead to severe deterioration in quality of life. While published data demonstrate 10kHz SCS provides substantial refractory pain relief and neurologic improvement for PDN patients1, here we report durability of these outcomes. Methods: Prospective, multicenter, RCT to document the impact of 10kHz SCS on PDN. Participants had PDN symptoms ≥12 months (M) , refractory to medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]) , and hemoglobin A1c ≤10%. Patients (N=216) were allocated 1:1 to 10kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone with optional crossover at 6 M. Results: The 10kHz SCS patients maintained substantial pain relief from 3 M, averaging 81.9% (95%CI 77.3 - 86.5) decrease at 24 M. At 6 M follow up, 0% of 10kHz SCS participants but 93% of eligible CMM patients elected to crossover. After SCS, both groups reported similar significant improvements in pain, sleep disturbance, and in pain interference with mood and daily activities (see Figure 1) . There were no stimulation-related neurological deficits and 6 total explants (3.9%) , 5 due to procedure-related infections and 1 as a precaution for endocarditis. Conclusions: The largest RCT to date of SCS management of PDN demonstrates safety, durable pain relief and neurologic improvement over 24 months with 10 kHz SCS. Disclosure E. Petersen: Consultant; Abbott, Biotronik, Boston Scientific Corporation, Medtronic, Nalu, Neuros Medical, Nevro Corp., Presidio, Saluda Medical, Vertos Medical Inc., Research Support; Medtronic, Neuros Medical, Nevro Corp., ReNeuron, Saluda Medical, SPR, Stock/Shareholder; neuro42, SynerFuse. C. Yu: Consultant; Boston Scientific Corporation, Nevro Corp., Research Support; Nevro Corp. A. Nairizi: Consultant; Nevro Corp. D. G. Patterson: Advisory Panel; AIS, Consultant; Pajunk Medical, Other Relationship; Abbott, CornerLoc, Flowonix, Saluda Medical, Vertiflex, Vertos, Vivex Biologics, Research Support; Nevro Corp., Speaker’s Bureau; AbbVie Inc., Lundbeck. V. Galan: None. R. Bundschu: None. N. Mehta: Consultant; Nevro Corp. D. Sayed: Consultant; Nevro Corp. D. Dibenedetto: None. K. A. Sethi: None. P. W. Wu: None. T. G. Stauss: None. C. Argoff: Consultant; Nevro Corp. C. E. Nasr: Advisory Panel; Exelixis, Horizon Therapeutics plc, Neurogastrx, Nevro Corp., Research Support; Siemens. R. Taylor: Consultant; Nevro Corp. D. L. Caraway: Employee; Nevro Corp. J. A. Scowcroft: Research Support; Boston Scientific Corporation, Nevro Corp., Saluda Medical. E. Brooks: Employee; Nevro Corp., Presidio Medical, Stock/Shareholder; Nevro Corp., Presidio Medical. J. L. White: Advisory Panel; Nevro Corp. S. M. Sills: None. K. Amirdelfan: Consultant; Nevro Corp. M. Guirguis: Advisory Panel; Averitas Pharma, Inc., Boston Scientific Corporation, Pacira BioSciences, Inc., Consultant; Avanos Medical, Inc., Nevro Corp., OmniaMed, Saluda Medical. J. Xu: None. Funding Nevro Corp.

Background: Surgical options for thoracic pain are limited and carry significant risk and morbidity. Spinal cord stimulation has the potential to be used for treatment of thoracic pain, as it has been useful for treating multiple types of chronic pain. Conventional tonic stimulation is limited in the treatment of thoracic pain, as it can produce paresthesia that is difficult to localize. Conversely, high-frequency spinal cord stimulation (HF-SCS) does not activate dorsal column Aβ fibers and does not produce paresthesia, and thus may be more beneficial in treating thoracic back pain not manageable with tonic stimulation. Objectives: To evaluate (1) the efficacy of 10 kHz HF-SCS for patients with chronic thoracic pain; and (2) appropriate paresthesia-free lead placement and programming targets for 10 kHz HF-SCS for patients with chronic thoracic pain. Study Design: Retrospective case series. Setting: Multisite academic medical center or pain clinic. Methods: A retrospective chart review was performed on 19 patients with thoracic back pain who underwent HF-SCS implantation. These patients had lead placement and stimulation between the T1-T6 vertebral levels. Outcome measures collected include location of device implant, stimulation settings, and pain scores at baseline, end of trial, and 1, 6, and 12 months postimplant. Followup phone calls collected information on if the patient reported functional improvement, improved sleep, or decreased pain medication usage. A Wilcoxon signed-rank test compared differences in mean pain scores across time points. Results: Significantly decreased Visual Analog Scale scores were observed with 17/19 (89.5%) patients demonstrating response to therapy (> 50% reduction in pain scores). These results were sustained relative to baseline at 1, 6, and 12 months postimplant, depending on length of followup. Many patients also reported functional improvement (17/19), improved sleep (14/19), and reduction in use of pain medications after implantation (9/19). A total of 15/19 patients reported best relief when contacts over T1 or T2 vertebrae were used for stimulation. Limitations: This study is limited by its retrospective design. Additionally, including documentation from multiple sites may be prone to selection and abstraction bias. Data were also not available for all patients at all time points. Conclusions: HF-SCS may be a viable option for significant, long-lasting pain relief for thoracic back pain. There may also be evidence for anatomically based lead placement and programming for thoracic back pain. Randomized, controlled trials with extended follow-up are needed to further evaluate this therapy. Key words: Thoracic pain, back pain, spinal cord stimulation, high frequency, 10 kHz

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

Background: Six million adults in the U.S. are living with painful diabetic neuropathy (PDN) and current treatments are ineffective for many. Preliminary data suggest 10 kHz spinal cord stimulation (SCS) relieves pain and may improve sensation in refractory patients. Methods: Prospective, multicenter, randomized controlled trial (SENZA-PDN) with 216 subjects assigned 1:1 to 10 kHz SCS (Nevro Corp.) combined with conventional medical management (CMM) or CMM alone. Patients with PDN symptoms ≥12 months, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), hemoglobin A1c ≤10%, and upper limb pain intensity Results: Randomization of 113 subjects to 10 kHz SCS+CMM and 103 to CMM resulted in groups well-matched at baseline. There were 2 procedure-related infections in the 10 kHz SCS+CMM group (1.8%). At 3-month follow-up, there were clear differences in lower limb pain scores (Fig 1A) and Diabetes Quality of Life (Fig 1B). Patients in the 10 kHz SCS+CMM group demonstrated improvements in sensation on physical examination (Fig 1C) and by patient report of numbness (Fig 1D). In addition, differences between treatment groups were observed in 6-minute walk test distance (Fig 1E) and sleep (Fig 1F). Conclusion: SENZA-PDN is the largest RCT to-date of SCS management of PDN and will inform the treatment continuum. Disclosure E. Petersen: Consultant; Self; Abbott, Medtronic, Neuros Medical, Nevro. Research Support; Self; Medtronic, Neuros Medical, Nevro, ReNeuron. T. Stauss: None. J.L. White: Research Support; Self; Allergan plc., Astellas Pharma Inc., Bayer Healthcare Pharmaceuticals Inc., Bristol-Myers Squibb, Eli Lilly and Company, Fitbit, Inc., Nevro, NovMetaPharma Co. Ltd., Theracos, Inc. S.M. Sills: None. K. Amirdelfan: Consultant; Self; Biotronik, Medtronic, Nevro Corporation, Saluda. M. Guirguis: Consultant; Self; Boston Scientific, nevro incop, spr. J. Xu: None. C. Yu: None. A. Nairizi: None. D.G. Patterson: Research Support; Self; Nevro Corporation. V. Galan: None. N. Mehta: Advisory Panel; Self; Nevro. Research Support; Self; Nevro. S.P. Lad: None. D. DiBenedetto: None. P.W. Wu: None. C.E. Nasr: Other Relationship; Self; Exilxis, Neurogastrx, Nevro Corp. R. Taylor: Consultant; Self; Nevro. E.S. Brooks: Employee; Self; Nevro. J. Subbaroyan: Employee; Self; Nevro Corp. B. Gliner: Employee; Self; Nevro Corp. D.L. Caraway: Employee; Self; Nevro. N. Mekhail: Consultant; Self; Boston Scientific, Nevro, Nuvectra, Relievant, Saluda, Sollis Therapeutics, Vertos Medical. Research Support; Self; Halyard, Mallinckrodt Pharmaceuticals, Mesoblast, Neuros Medical. Funding Nevro Corp.

Tight interconnections exist between water, energy, and food systems. As stresses on these resource systems continue to increase, there is a growing need to better quantify and understand the trade...

IMPORTANCE: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. OBJECTIVE: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). 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 A(1c) (HbA(1c)) 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. INTERVENTIONS: Implanted medical device delivering 10-kHz SCS. 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 HbA(1c) over 6 months. 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

Background: The necessity of aggressive pain management in the hospital setting is becoming increasingly evident. It has been shown to improve patient outcomes, and is now an avenue for Medicare to assess reimbursement. In this cohort analysis, we compared the March 2008 to the December 2012 Hospital Consumer Assessment of Health Plans Survey (HCAHPS) reports in order to determine if pain management has improved in the United States after this national standardized survey was created. Objective: To evaluate whether pain perception would improve in the 2012 report relative to the 2008 report. Study Design: Statistical analyses were conducted with the HCAHPS report to compare pain control in regards to hospital type, hospital ownership, and individual hospitals. Using the question, “How often is your pain controlled?,” T-tests were used to compare each hospital type. Hospital ownerships were assessed via analysis of variance (ANOVA) testing. T-tests were conducted to track the difference of hospital performance between the 2008 and the 2012 report. Paired management data were obtained from hospitals that participated in both reports and were assessed using paired T-tests. Setting: This survey was administered to a random sample of adult inpatients between 48 hours and 6 weeks after discharge from any hospital reporting to Centers for Medicare and Medicaid (CMS) across the US. Limitations: Limitations of this study include response bias, recall bias, and there may be bias related to types of people likely to respond to a survey, but this is inherent to data that is collected on a voluntary response. Additionally, a 3% increase in the number of patients rating their pain as always well-controlled, while statistically significant, admittedly may not be clinically significant. In addition, the raw data collected is adjusted for the effects of patient-mix. The statistical analyses performed to derive the final quarterly HCAHPS reports are unavailable to us and therefore we cannot comment on how individual factors such as age, sex, race, and education or the interaction of the aforementioned affect responses about the patient’s perception on how well their pain was controlled between 2008 and 2012. Results: Two thousand three hundred and ninety five hospitals reported pain management data in both 2008 and 2012. In 2012, hospitals improved their ability to “always control a patients pain” by 3.07% (P < 0.0001) in comparison to the baseline March 2008 report, which was statistically significant. According to the 2012 data, the discrepancy in pain management between acute care hospitals and critical access hospitals was 3.33% which was statistically significant (P < 0.05). Government hospitals were shown to manage pain better at baseline, but all 3 types of ownership improved their pain scores between the 2 reports which was shown to be statistically significant (P < 0.01). Discussion: The HCAHPS survey is a national public standardized report used as a way to compare care in the United States. Patient pain perception has improved between the 2008 and 2012 reports. Further studies are needed to evaluate critical care hospitals. Key words: HCAHPS, pain scores, patient perception, national comparison of hospitals, Agency for Healthcare Research and Quality (AHRQ), acute care hospitals, critical access hospitals, pain management

Branched-chain amino acids (BCAA), Leu, and the signaling pathways they regulate have been reported to either improve or worsen adiposity and insulin sensitivity. Therefore, it is unclear whether dietary supplementation of Leu would be beneficial. To help address this question, we examined the effect of adding Leu (150 mmol/L; Expt. 1 and Expt. 2) or BCAA (109 mmol/L of each; Expt. 3) to the drinking water on diet-induced obesity (induced with a 60-kJ% fat diet) in singly housed C57BL6/J male mice for at least 14 wk. Liquid and solid food intakes were evaluated weekly along with body weight. During the last few weeks, several blood samples were taken at different times for plasma glucose, total cholesterol, or Leu measurements. Metabolic rate by indirect calorimetry, locomotor activity by light beam breaking, body composition by H1-NMR, and insulin tolerance were also determined. Compared with control, supplementation did not affect body weight, food intake, oxygen consumption, locomotor activity, body composition, insulin tolerance, or total cholesterol. In fed mice, this method of Leu supplementation only increased plasma Leu by 76% when the supplemented group was compared with control. On the other hand, after overnight food deprivation, the plasma Leu did not differ between these 2 groups, even though the mice in the supplemented group had continuous access to Leu-containing water during the solid food deprivation. Taken together, the results do not provide evidence that either Leu or BCAA supplementation of drinking water ameliorates diet-induced obesity in mice, although it may improve glycemia.