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Introduction: The International Neuromodulation Society convened a multispecialty group of physicians and scientists based on expertise with international representation to establish evidence-based guidance on intrathecal drug delivery in treating chronic pain. This Polyanalgesic Consensus Conference (PACC)® project, created more than two decades ago, intends to provide evidence-based guidance for important safety and efficacy issues surrounding intrathecal drug delivery and its impact on the practice of neuromodulation., Materials and Methods: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when PACC® last published guidelines) to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence is scant., Results: The PACC® examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process., Conclusions: The PACC® recommends best practices regarding intrathecal drug delivery to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate., Competing Interests: Conflict of Interest Alaa Abd-Elsayed is a consultant for Medtronic. Philip Kim reports consulting fees from Medtronic, personal fees from TerSera, outside the submitted work; personal fees from Biotronik and Medtronic on a medical board; reseach support from Biotronik, Medtronic, Boston, Nevro, Saluda, and Cornerloc; and participation in a data safety monitoring board on RTX on Morton neuroma study. Christophe Perruchoud reports consulting fees, honoraria, and participation on a data safety monitoring board or advisory board for Medtronic. Anjum Bux reports personal fees from Flowonix Corp, Boston Scientific, AIS, Medtronic, and Vertos, outside the submitted work. Rui Duarte reports personal fees from Saluda Medical, Boston Scientific, Medtronic, and Mainstay Medical, outside the submitted work. Michael Saulino reports research grants from Medtronic and Flowonix; fellowship support from Medtronic, Piramal, and Saol; Denis Dupoiron reports personal fees from Medtronic and Esteve, outside the submitted work. Dennis Patin consults for Medtronic, Abbott, Boston Scientific, and Nevro. Julie G. Pilitsis reports grants and other from Boston Scientific, Nevro, Abbott, TerSera, and Medtronic; other from Saluda, Aim Medical Robotics, and Karuna Labs; grants from National Institutes of Health (NIH) 2R01CA166379-06; and grants from NIH U44NS115111, outside the submitted work. Lawrence R. Poree reports personal fees from Medtronic and Nalu, and grants and personal fees from Saluda, outside the submitted work. Harry Sukumaran reports personal fees from Abbott, Boston Scientific, and Nevro, and personal fees and nonfinancial support from Vertos Medical, outside the submitted work. Erik Shaw reports support from Pfizer/Lilly for tanezumab articles; consulting fees and/or honoraria from TerSera, Boston Scientific, SPR Therapeutics; participation on a data safety monitoring board or advisory board for Pfizer/Lilly NGF blocker; and stock options from SpineThera and ROM Tech. Tony L. Yaksh reports grants from NIH-National Institute of Neurological Disorders and Stroke (NINDS), other from CODA, IONIS, and Medtronic during the conduct of the study; grants from NIH-NINDS, IONIS, and Medtronic, outside the submitted work. Robert M. Levy is an unpaid and uncompensated consultant for Abbott, Biotronik, Nalu, and Synergia. The remaining authors reported no conflict of interest., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on using intrathecal drug delivery in chronic pain treatment. This Polyanalgesic Consensus Conference (PACC)® project's scope is to provide evidence-based guidance for clinical pharmacology and best practices for intrathecal drug delivery for cancer pain., Materials and Methods: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Meeting Abstracts, and Scopus from 2017 (when the PACC last published guidelines) to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations were based on the strength of evidence, and when evidence was scant, recommendations were based on expert consensus., Results: The PACC evaluated the published literature and established evidence- and consensus-based expert opinion recommendations to guide best practices in treating cancer pain. Additional guidance will occur as new evidence is developed in future iterations of this process., Conclusions: The PACC recommends best practices regarding the use of intrathecal drug delivery in cancer pain, with an emphasis on managing the unique disease and patient characteristics encountered in oncology. These evidence- and consensus-based expert opinion recommendations should be used as a guide to assist decision-making when clinically appropriate., Competing Interests: Conflict of Interest Shane E. Brogan acts as a paid consultant for Medtronic. Eric Buchser reports grants from the Swiss National Foundation and the Commission for Technology and Innovation; and grants, personal fees and nonfinancial support from Medtronic, during the conduct of the study. Timothy R. Deer reports no conflicts that pertain to intrathecal therapy; reports conflicts within the neuromodulation field that include consulting for Abbott, Saluda, Ethos, Nalu, PainTeq, and Cornorloc; he also holds a patent pending with Abbott; is on the advisory board of Abbott and Nalu; has stock options Saluda, Spinethera, and Nalu; and has institutional research grants from Abbott, Saluda, Vertiflex and Mainstay. Denis Dupoiron reports personal fees from Medtronic and Esteve during the conduct of the study. Amitabh Gulati reports personal fees from Medtronic, Flowonix, AIS HealthCare, SPR Therapeutics, Nalu Medical, Bausch Health, and Spark Medical, outside the submitted work. Jennifer Hah reports grants from NIH NIDA, outside the submitted work. Gladstone C. McDowell II reports personal fees and other from Medtronic Corporation; personal fees, nonfinancial support, and other from Flowonix Corporation and TerSera Therapeutics, outside the submitted work. Christophe Perruchoud reports grants and personal fees from Medtronic and Boston Scientific, during the conduct of the study; and personal fees from Medtronic and Boston Scientific, outside the submitted work. Fabian Piedimonte reports personal fees from Medtronic and Abbott, which stopped in June 2020. Julie G. Pilitsis reports grants and other from Boston Scientific, Nevro, Abbott, Medtronic, and TerSera; other from Saluda; grants from NIH 2R01CA166379-06, other from Aim Medical Robotics and Karuna Labs; and grants from NIH U44NS115111, outside the submitted work. Jason E. Pope reports other from Ethos Labs, Flowonix, Saluda, PainTeq, Aurora Spine, Thermaquil, Celeri Health, Spine Thera, AGR, NIS, Abbott, Medtronic, Biotronik, Mainstay, Muse, AIS, SPR Therapeutics, TerSera, Vertiflex, Boston Scientific, Vertos, SPARK, and WISE, outside the submitted work. Michael F. Saulino reports research grants from Medtronic and Flowonix; fellowship support from Medtronic, Piramal, and Saol. Peter S. Staats reports grants from Saluda, Nalu, AIS Therapeutics, Thermaquil, Biotronik, electroCore and Vertos, outside the scope of this work; royalties from the Averitas-Qutenza Patch, outside the scope of this work; payment or honoraria from Medtronic and SPR Therapeutics, outside the scope of this work; patents for vagus nerve and topical capsaicin products; participation in a Data Safety Monitoring or Advisory Board for Nalu and Saluda; a leadership role in the World Institute of Pain, American Society of Pain and Neuroscience, American Society of Interventional Pain Physicians, and the Florida Academy of Pain Management; and stock options in Saluda, Nalu and electroCore. Mark S. Wallace reports grants from NIH and is a consultant to TerSera. Tony L. Yaksh reports grants from NIH NINDS, other from CODA, IONIS, and Medtronic, during the conduct of the study; and grants from NIH-NINDS, IONIS, and Medtronic, outside the submitted work. The remaining authors reported no conflict of interest., (Copyright © 2024 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Introduction: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety., Materials and Methods: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant., Results: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process., Conclusions: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate., Competing Interests: Conflict of Interest Timothy R. Deer consults for Abbott, Saluda, Ethos, Nalu, PainTeq, and Cornorloc; holds a patent pending with Abbott; is on the advisory board of Abbott and Nalu; has stock options with Saluda, Spinethera, and Nalu; and has institutional research grants from Abbott, Saluda, Vertiflex, and Mainstay. Dawood Sayed consults for Abbott, Saluda, PainTeq, and Surgentec and holds stock in PainTeq, Surgentec, Neuralace, Vertos, SPR, and Mainstay. Jason E. Pope serves as a consultant, on the advisory board, and conducts research for Ethos Labs, Flowonix, Saluda, PainTeq, Aurora Spine, Mainstay, Thermaquil, Abbott, Vertiflex, Vertos, and SPR Therapeutics; owns stock in PainTeq, Aurora Spine, Thermaquil, Spine Thera, Saluda, Abbott, AGR, NIS, Vertos, Celeri Health, and SPARK; receives royalties from Aurora Spine; consults for Biotronik, Medtronic, Boston Scientific, and WISE; conducts research for Ethos, Celeri Health, and Boston Scientific; and serves on the advisory board of Spine Thera. Steven M. Falowski consults for Abbott, Medtronic, Boston Scientific, Vertos, and Saluda. Research is performed with Abbott, Medtronic, Biotronik, Saluda, and Vertiflex. Equity positions are held in Saluda, CornerLoc, SPR Therapeutics, Thermaquil, Stimgenics, SpineThera, Neural Integrative Solutions, and AGR. Konstantin V. Slavin reports grants from Medtronic, Abbott, and Boston Scientific; personal fees from Medtronic, Abbott, Boston Scientific, MSEI, Nuvectra, and Stimwave; and nonfinancial support from Neuramodix, Thermaquil, Higgs Boson, and Stimwave, outside the submitted work. Sean Li consults for Abbott, Avanos, Averitas Pharma, Biotronik, Nalu, NeuroOne, PainTeq, Saluda, SPR Therapeutics, and Vertos Medical; and has research grants from Avanos, Averitas Pharma, Biotronik, Nevro, PainTeq, Saluda, and SPR Therapeutics and equity in Nalu and NeuroOne. Lawrence R. Poree reports personal fees and other from Saluda Medical Inc, personal fees and other from Nalu Inc, personal fees from Medtronic, and personal fees from Gimer, outside the submitted work. Sam Eldabe reports personal fees from Medtronic, Mainstay Medical, Saluda Medical, and Boston Scientific; and grants from Medtronic, during the conduct of the study. Kaare Meier reports teaching fees from Abbott, outside the submitted work; his institution has received travel support from Abbott and Boston Scientific. Julie G. Pilitsis is a consultant for Boston Scientific, Nevro, TerSera, Medtronic, Saluda, and Abbott and receives grant support from Medtronic, Boston Scientific, Abbott, Nevro, TerSera, and National Institutes of Health (NIH) 2R01CA166379-06 and NIH U44NS115111. She is medical advisor for Aim Medical Robotics and Karuna and has stock equity. Alexios G. Carayannopoulos’ institution has received grant/research money in his name from Medtronic, Abbott, Nevro, Boston Scientific, Asahi, Aspen Medical, NIH, and the Defense Advanced Research Projects Agency. Christophe Perruchoud reports grants and personal fees from Medtronic and Boston Scientific during the conduct of the study; and advisory board membership for Medtronic and Boston Scientific. Amir Hadanny reports consulting fees and stock options from Aviv Scientific and EEG-Sense, and travel support from Aviv Scientific. Eric Lee consults with Abbott, Nalu and Boston Scientific. Mehul J. Desai consults for Medtronic, Nalu Medical, and SPR Therapeutics, and has stock options in SPR Therapeutics, SynerFuse, Virdio Health, and VRYSA Technologies. Ajay Antony consults for Saluda, Vertos, Abbott, Boston Scientific, and PainTeq. Fabian Piedimonte reports personal fees from Medtronic and Abbott outside the submitted work and divested as of June 2020. Robert M. Levy is an uncompensated consultant for Nalu, Saluda Medical, Mainstay Medical; and has stock options from Nalu and Saluda Medical obtained before 2019 and not exercisable through the duration of his terms as INS president and editor-in-chief of the journal, Neuromodulation: Technology at the Neural Interface. The remaining authors reported no conflict of interest., (Copyright © 2024 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Background: Despite increased attention paid to assessment and management, pain continues to be a prevalent and undertreated symptom in patients with cancer. Intrathecal drug delivery (IDD) is a therapeutic option that allows targeted delivery of analgesics to the intrathecal space., Objective: The aim of this review was to examine the efficacy of managing cancer-related pain with IDD. Secondary objectives included the effects of IDD on systemic opioid use and infection rates., Evidence Review: A systematic search of the literature published between 1990 and 2019 was performed to identify studies evaluating the efficacy and/or safety of IDD with external or implanted pumps in patients with cancer-related pain. Data were extracted and meta-analyses performed to determine the mean changes in pain levels at short-, mid-, and long-term intervals; changes in opioid (oral morphine equivalent [OME]) daily dose; and infection rates. Changes were assessed compared with baseline., Findings: Pain levels were decreased from baseline: On a 0 to 10 scale, mean differences were -4.34 (95% CI [-4.93 to -3.75], p < 0.001) at 4 to 5 weeks; -4.34 (95% CI [-5.07 to -3.62], p < 0.001) at 6 to 12 weeks; and -3.32 (95% CI [-4.60 to -2.04], p < 0.001) at >6 months. Weighted mean OME consumption was reduced by 308.24 (SE = 22.72) mg/d. Weighted mean infection rates were ∼3% for external and implanted pumps., Conclusions: Meta-analyses show a statistically significant and sustained decrease in cancer pain with IDD, compared with baseline. Systemic opioid consumption was reduced on average by >50% after IDD. Infection rates were comparable with other indications., (Copyright © 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Precise localization of the center of the reservoir access port (RAP) of intrathecal pump is a crucial step to ensure a safe refill procedure. In difficult refill cases, ultrasound guidance has been reported useful. Being more expensive and time-consuming, the purpose of the study was therefore to identify situations in which sonographic localization is more accurate than the template method, in order to restrict its use to these defined conditions., Materials and Methods: The RAP was localized using the template provided by the manufacturer and by ultrasound guidance. The distance between the two points was measured. A distance superior to 3.5 mm, corresponding to the radius of the silicone septum of the RAP, was considered a clinically significant deviation., Results: During the study period, 22 patients underwent a total of 81 refill procedures. No significant correlation was found between the distance between the two points and age, height, weight, body mass index (BMI) or abdominal perimeter. The correlation was significant between distance and pump's depth. According to the ROC curve, the sensitivity of ultrasound identification of the RAP was 69.2% and the specificity 83.3% when the pump was implanted at a depth of 10 mm., Discussion: Our results are comparable to these published in the literature, pointing the usefulness of ultrasound for refill of deeply implanted pumps. Our study provides an additional element by specifying the depth from which the ultrasound seems to be superior to template., Conclusion: Poor accuracy in RAP identification of intrathecal pump can lead to life-threatening complications. The results of our study suggest that the localization of recessed-RAP can be improved by ultrasound in cases of pump implanted deeper than 10 mm. For more superficially implanted devices, the template method seems to be as accurate as ultrasound., (© 2019 International Neuromodulation Society.)

Introduction: Intrathecal (IT) drug infusion is an appropriate and necessary tool in the algorithm to treat refractory cancer and noncancer pain. The decision-making steps/methodology for selecting appropriate patients for implanted targeted drug delivery systems is controversial and complicated. Therefore, a consensus on best practices for determining appropriate use of IT drug infusion may involve testing/trialing this therapy before implantation., Methods: This current Polyanalgesic Consensus Conference (PACC) update was designed to address the deficiencies and emerging innovations since the previous PACC convened in 2012. A literature search identified publications available since the previous PACC publications in 2014, and relevant sources were contributed by the PACC members. After reviewing the literature, the panel determined the evidence levels and degrees of recommendations. The developed consensus was ranked as strong (>80%), moderate (50-79%), or weak (<49%)., Results: The trialing for IT drug delivery systems (IDDS) remains an area of continued controversy. The PACC recommendations for trialing are presented in 34 consensus points and cover trialing for morphine, ziconotide, and medication admixtures; starting doses and titration practices; measurements of success; trial settings and monitoring; management of systemic opioids during trialing; and the role of psychological evaluation. Finally, the PACC describes clinical scenarios in which IT trialing is required or not required., Conclusion: The PACC provides consensus guidance on best practices of trialing for IDDS implants. In addition, the PACC recommends that no trial may be required in certain patient populations., (© 2017 International Neuromodulation Society.)

Introduction: Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice., Methods: The current PACC update was designed to address the deficiencies and innovations emerging since the previous PACC publication of 2012. An extensive literature search identified publications between January 15, 2007 and November 22, 2015 and authors contributed additional relevant sources. After reviewing the literature, the panel convened to determine evidence levels and degrees of recommendations for intrathecal therapy. This meeting served as the basis for consensus development, which was ranked as strong, moderate or weak. Algorithms were developed for intrathecal medication choices to treat nociceptive and neuropathic pain for patients with cancer, terminal illness, and noncancer pain, with either localized or diffuse pain., Results: The PACC has developed an algorithmic process for several aspects of intrathecal drug delivery to promote safe and efficacious evidence-based care. Consensus opinion, based on expertise, was used to fill gaps in evidence. Thirty-one consensus points emerged from the panel considerations., Conclusion: New algorithms and guidance have been established to improve care with the use of intrathecal drug delivery., (© 2017 International Neuromodulation Society.)

Objectives: To define the key terms and concepts relating physical activity to chronic pain; to provide a brief overview of the various methods of assessment of physical activity; to review the current literature about physical activity and chronic pain; and to identify needs for future research., Materials and Methods: A narrative review based on results of a PubMed search (to May 2011) and the references of recent systematic reviews., Results: Many methods exist for measuring physical activity. Movement sensors, such as accelerometers, offer objective assessment of physical activity of patients with chronic pain. It is often assumed that patients who feel disabled and report daily life restrictions due to chronic pain also will be less physically active. Studies that have compared the activity of patients with chronic back pain with that of healthy individuals consistently showed that the relationship of physical activity and severity of pain, as well as the change in activity following interventions, was variable and complex., Conclusions: It is important to understand the relationship between physical activity and chronic pain. Future studies should objectively assess not only the pattern and complexity of that relationship but also the interaction with the patient's mood and ability to cope with the pain., (© 2014 International Neuromodulation Society.)

Objectives: This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system., Materials and Methods: Twenty adults with severe chronic pain who were under consideration for intrathecal (IT) therapy were enrolled in this open label, nonrandomized, pilot study. Informed consent was obtained. Demographics, medical/pain history, pain scores, and concomitant medications were recorded. A physical examination was performed. Creatine kinase was measured. Initial visual analog scale (VAS), blood pressure, heart rate, and respiratory rate were recorded. All patients received an initial bolus dose of 2.5 mcg ziconotide; the dose in the subsequent visits was modified according to response. Subsequent doses were 2.5 mcg, 1.2 mcg, or 3.75 mcg as per protocol. A good response (≥30% reduction in baseline pain VAS) with no side-effects on two occasions was considered a successful trial. Data were analyzed using a generalized estimating equations model, with pain VAS as the outcome and time (seven time points; preinjection and one to six hours postinjection) as the predictor., Results: Generalized estimating equations analysis of summary measures showed a mean reduction of pain VAS of approximately 25% at the group level; of 11 responders, seven underwent pump implantation procedure, two withdrew because of adverse effects, one refused an implant, and one could not have an implant (lack of funding from the Primary Care Trust)., Conclusions: Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system., (© 2012 International Neuromodulation Society.)

Introduction: Intrathecal (IT) pump failures usually result in decreased drug administration and symptom reoccurrence with or without withdrawal syndrome. We report a case of a leaking silicone septum associated to a systemic drug overdose., Case Report: An 84-year-old patient treated with IT clonidine for chronic back pain presented with a state of confusion, visual hallucinations, and hypertension two hours after an unremarkable pump (SynchroMed EL, Medtronic, Minneapolis, MN, USA) refill. The reservoir was emptied and 14 mL (8.4 mg of clonidine) was found to be missing (difference between retrieved and expected volumes). The pump was refilled and a check on the next day showed again a loss of 3.5 mL. A malfunction was suspected and the pump was replaced (SynchroMed II, Medtronic). The inspection of the external surface of the pump revealed severe damage to the silicone septum with multiple gouges due to needle scarring. A fluid leak also was clearly seen through the septum., Discussion: The signs and symptoms presented by this patient are consistent with clonidine overdose that resulted from a combination of a possible accidental pocket fill and a definite septum leak into the subcutaneous tissue. The damage to the silicone could be due to the loss of the nontraumatic properties of the Huber needles that are rubbed against the metallic case in attempting to locate the injection port during refill procedures., Conclusion: This observation is the first description of a silicone septum damage contributing to a pump dysfunction and drug overdose despite the use of appropriate needles for refilling., (© 2012 International Neuromodulation Society.)

Introduction: Spinal cord stimulation is a recognized treatment of chronic neuropathic and vascular pain. Recent data suggest that the use of very high-frequency (HF) stimulation modes does produce analgesia without paresthesia., Aim of the Study: To compare the efficacy of HF stimulation (HF spinal cord stimulation [HFSCS]) and sham stimulation on the patient's global impression of change (PGIC), pain intensity, and quality of life., Patients and Methods: Forty patients who have achieved stable pain relief with conventional SCS have been recruited. After randomization, HFSCS and sham are initiated in a double-blind randomized two-period-crossover design., Results: Complete data were available from 33 patients. The primary outcome was a minimal improvement in the PGIC. The proportion of patients responding under HFSCS was 42.4% (14/33 patients) vs. 30.3% (10/33 patients) in the sham condition. The mean benefit of HF vs. sham was not statistically significant with a proportion of 11.2% in favor of HFSCS (p = 0.30). There was a highly statistically significant "period effect," irrespective of treatment received, with 51.5% of patients (N = 17) improving at visit 3 vs. 21.2% (N = 7) at visit 5 (p = 0.006). The mean pain visual analog scale (VAS) on sham was 4.26 vs. 4.35 on HFSCS (p = 0.82) and the mean EuroQol five-dimensional (EQ-5D) index with HFSCS was 0.480 vs. 0.463 with sham (p = 0.78)., Conclusion: This is the first randomized double-blind study on SCS. HFSCS was equivalent to sham for the primary outcome (improvement of PGIC) as well as for both the secondary outcomes (VAS and EQ-5D index). There was a highly statistically significant "period effect" (p = 0.006) with improved PGIC scores in the first study period regardless of the treatment. The same trend was seen for VAS and EQ-5D. It appears that the effect of HFSCS and sham is equal and only the order in the sequence, not the nature of the treatment, seems to dictate the effect., (© 2013 International Neuromodulation Society.)

Background:   Complications associated with intrathecal pumps may be linked to the surgical procedure, the implanted device, or the medication itself., Case Reports:   Three patients treated chronically with intrathecal clonidine presented with clonidine overdose due to inadvertent extravasation during the refilling procedure. All patients experienced loss of consciousness and severe systemic hypertension that required aggressive parenteral treatment., Discussion:   Clonidine is an alpha-2 agonist with a nearly 100% bioavailability after oral or rectal administration. With high plasma concentration secondary to massive systemic overdose, the specificity for the alpha-2 receptor is lost and an alpha-1 agonist activity predominates and causes marked hypertension. Management of clonidine overdose consists of supportive therapy guided by signs and symptoms., Conclusion:   Inadvertent injection into the subcutaneous pocket rather than the reservoir is rare but very dangerous as the drug cannot be retrieved and massive doses are involved. Signs and symptoms of systemic overdose with drugs commonly used in implanted drugs delivery system should be well known to ensure early diagnosis and treatment., (© 2011 International Neuromodulation Society.)