Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain

Leonardo Kapural,1 Jim Melton,2 Billy Kim,3 Priyesh Mehta,4 Abindra Sigdel,5 Alexander Bautista,6 Erika A Petersen,7 Konstantin V Slavin,8,9 John Eidt,10 Jiang Wu,11 Said Elshihabi,12 Jason Matthew Schwalb,13 H Edward Garrett Jr,14 Elias Veizi,15 Giancarlo Barolat,16 Ravi R Rajani,17 Peter C Rhee,18 Maged Guirguis,19 Nagy Mekhail20 1Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, NC, USA; 2Department of Vascular Surgery, Cardiovascular Health Clinic, Oklahoma City, OK, USA; 3Department of Vascular Surgery, The Surgical Clinic, Nashville, TN, USA; 4Department of Pain Medicine, Meta Medical Research Institute, Dayton, OH, USA; 5Department of Surgery, University of Louisville, Louisville, KY, USA; 6Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USA; 7Department of Neurosurgery, University of Arkansas, Little Rock, AR, USA; 8Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL, USA; 9Department of Neurology, Jesse Brown VA Medical Center, Chicago, IL, USA; 10Department of Vascular Surgery, Baylor Scott and White Heart and Vascular Hospital Dallas, Dallas, TX, USA; 11Department of Anesthesiology & Pain Medicine, University of Washington Medical Center, Seattle, WA, USA; 12Department of Neurosurgery, Legacy Brain & Spine Surgical Center, Atlanta, GA, USA; 13Department of Neurosurgery, Henry Ford Medical Group, Detroit, MI, USA; 14Department of Vascular Surgery, University of Tennessee-Memphis, Memphis, TN, USA; 15Department of Pain Medicine, VA Northeast OH Healthcare System, Cleveland, OH, USA; 16Department of Neurosurgery, Barolat Neuroscience, Presbyterian/St Luke’s Medical Center, Denver, CO, USA; 17Department of Vascular Surgery, Emory University and Grady Memorial Hospital, Atlanta, GA, USA; 18Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA; 19Department of Interventional Pain Management, Ochsner Health System, New Orleans, LA, USA; 20Department of Pain Management, Cleveland Clinic, Cleveland, OH, USACorrespondence: Leonardo Kapural, Carolinas Pain Institute and Center for Clinical Research, 145 Kimel Park Dr #330, Winston-Salem, NC, 27103, USA, Email [email protected]: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain.Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥ 50% pain relief 30 min after treatment in ≥ 50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined.Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups.Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.Keywords: post-amputation pain, phantom limb pain, neuromodulation, peripheral nerve stimulation, high-frequency nerve bloc

Diarrhoea and constipation during artificial nutrition in intensive care unit: A prospective observational study

Purpose: To describe the occurrence of gastrointestinal (GI) complications, specifically diarrhoea and constipation, in artificially (enterally or parenterally) fed critically ill patients within their first seven-day stay in Intensive Care Unit (ICU). Methods: Observational prospective study conducted from September 1st to October 30th, 2019 and from August 1st to October 30th, 2021, in an ICU of a 1000-bed third-level hospital. General characteristics, nutritional variables, and medications administered were recorded and analysed. This study was registered on ClinicalTrials.gov (Identifier: NCT05473546). Results: In total, 100 critically ill patients were included. Diarrhoea was present in 44 patients (44.0%), while constipation occurred in 22 (22.0%) patients. Patients with diarrhoea were generally those admitted for respiratory failure, whereas patients without diarrhoea were mostly affected by neurological disorders (22.7% vs 25%, respectively; p = 0.002). Likewise, patients with constipation were primarily those admitted for trauma (36.4%). Trauma patients were almost 24 times more likely to be constipated than patients with respiratory failure (OR 23.99, CI 1.38–418.0) and patients receiving diuretics were over 16 times more likely to have diarrhoea than patients not receiving diuretics (OR 16.25, IC 1.89–139.86). Conclusion: GI complications of enteral nutrition represent still a very common issue in ICU. The main predictor of constipation was an admission for trauma whereas the main predictor of diarrhoea was the use of diuretics. Clinicians should consider and integrate these findings into more personalized nutritional and management protocols to avoid gastrointestinal complications

Interstitial Cystitis – Elucidation of Psychophysiologic and Autonomic Characteristics (the ICEPAC Study): design and methods

Thomas Chelimsky,1 Gisela Chelimsky,1 N Patrick McCabe,2 Megan Louttit,3 Adonis Hijaz,3 Sangeeta Mahajan,3 Tatiana Sanses,3 CA Tony Buffington,4 Bradford Fenton,5 Thomas Janicki,3 Sarah Ialacci,2 Elias Veizi,3 Di Zhang,2 Firouz Daneshgari,2,3 Robert Elston,2 Jeffrey Janata2,31The Medical College of Wisconsin, Departments of Neurology and Gastroenterology, Milwaukee, WI, 2Case Western Reserve University, Department of Neurology, Cleveland, OH, 3University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, 4The Ohio State University, Department of Veterinary Clinical Sciences, Columbus, OH, 5Summa Health System, Department of Gynecology, Akron, OH, USABackground and purpose: Interstitial cystitis/bladder pain syndrome (IC/BPS) is relatively common and associated with severe pain, yet effective treatment remains elusive. Research typically emphasized the bladder's role, but given the high presence of systemic comorbidities, the authors hypothesized a pathophysiologic nervous system role. This paper reports the methodology and approach to study the nervous system in women with IC/BPS. The study compares neurologic, urologic, gynecologic, autonomic, gastrointestinal, and psychological features of women with IC/BPS, their female relatives, women with myofascial pelvic pain (MPP), and healthy controls to elucidate the role of central and peripheral processing.Methods and results: In total, 228 women (76 IC/BPS, 76 MPP, 38 family members, and 38 healthy controls) will be recruited. Subjects undergo detailed screening, structured neurologic examination of limbs and pelvis, tender point examination, autonomic testing, electrogastrography, and assessment of comorbid functional dysautonomias. Interpreters are blinded to subject classification. Psychological and stress response characteristics are examined with assessments of stress, trauma history, general psychological function, and stress response quantification. As of December 2012, data collection is completed for 25 healthy controls, 33 IC/BPS ± MPP, eight MPP, and three family members. Recruitment rate is accelerating and strategies emphasize maintaining and encouraging investigator participation in study science, internet advertising, and presentations to pelvic pain support groups.Conclusion: The study represents a comprehensive, interdisciplinary approach to sampling autonomic and psychophysiologic characteristics of women with IC/BPS. Despite divergent opinions on study methodologies based on specialty experiences, the study has proven feasible to date and different perspectives have proved to be one of the greatest study strengths.Keywords: interstitial cystitis, bladder pain syndrome, autonomic nervous system, psychophysiology, pelvic pain, myofascial pai

Real-time fusion-imaging in low back pain: a new navigation system for facet joint injections

Aims and Objectives: The aim of the current study is to present our experience in lumbar spine interventional procedures performed with a newly developed multimodal echo-navigator (EcoNav) and to evaluate short-term clinical outcomes of a series of patients affected by facet joint disease (FJD) treated with steroid and anaesthetic injection under fusion-imaging guidance, compared to a cohort of patients that received the same treatment under computed tomography (CT) guidance. Methods: Sixty-five consecutive patients (34 females; mean age 68.3 \ub1 12.8 years) with a clinical diagnosis of non-radicular low back pain lasting for more than 6-weeks and magnetic resonance (MR) or CT confirmed FJD were enrolled for image-guided FJI. Twenty-eight patients underwent FJI with fusion-guided technique, while CT-guided procedures were performed in the other cases. Clinical and procedural data were recorded and compared at a mean follow-up of 6.1 \ub1 2.0 months. Results: A significant improvement in clinical parameters was observed for both fusion-guided and CT-guided group. Comparing both groups, no statistically significant difference could be detected neither at baseline conditions nor during the follow-up period. No significant periprocedural complication occurred in both groups. A satisfaction rate of 92.3 and 81.1% was reported for fusion-guided and CT-guided group, respectively. Conclusion: EcoNav fusion-imaging system represents a safe, feasible, effective and reproducible guidance option in FJD infiltration procedures, also avoiding use of ionising radiations