Five-Year Longitudinal Follow-up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

Variables associated with nonresponders to high-frequency (10 kHz) spinal cord stimulation.

INTRODUCTION: The use of spinal cord stimulation (SCS) therapy to treat chronic pain continues to rise. Optimal patient selection remains one of the most important factors for SCS success. However, despite increased utilization and the existence of general indications, predicting which patients will benefit from neuromodulation remains one of the main challenges for this therapy. Therefore, this study aims to identify the variables that may correlate with nonresponders to high-frequency (10 kHz) SCS to distinguish the subset of patients less likely to benefit from this intervention. MATERIALS AND METHODS: This was a retrospective single-center observational study of patients who underwent 10 kHz SCS implant. Patients were divided into nonresponders and responders groups. Demographic data and clinical outcomes were collected at baseline and statistical analysis was performed for all continuous and categorical variables between the two groups to calculate statistically significant differences. RESULTS: The study population comprised of 237 patients, of which 67.51% were responders and 32.49% were nonresponders. There was a statistically significant difference of high levels of kinesiophobia, high self-perceived disability, greater pain intensity, and clinically relevant pain catastrophizing at baseline in the nonresponders compared to the responders. A few variables deemed potentially relevant, such as age, gender, history of spinal surgery, diabetes, alcohol use, tobacco use, psychiatric illness, and opioid utilization at baseline were not statistically significant. CONCLUSION: Our study is the first in the neuromodulation literature to raise awareness to the association of high levels of kinesiophobia preoperatively in nonresponders to 10 kHz SCS therapy. We also found statistically significant differences with greater pain intensity, higher self-perceived disability, and clinically relevant pain catastrophizing at baseline in the nonresponders relative to responders. It may be appropriate to screen for these factors preoperatively to identify patients who are less likely to respond to SCS. If these modifiable risk factors are present, it might be prudent to consider a pre-rehabilitation program with pain neuroscience education to address these factors prior to SCS therapy, to enhance successful outcomes in neuromodulation.

Selective Detection of Erythrocytes with QCMs-ABO Blood Group Typing.

Blood transfusion, as well as organ transplantation, is only possible after prior blood group (BG) typing and crossmatching. The most important blood group system is that of Landsteiner's ABO classification based on antigen presence on the erythrocyte surfaces. A mass sensitive QCM (quartz crystal microbalance) sensor for BG typing has been developed by utilizing molecular imprinting technology. Polyvinylpyrrolidone (crosslinked with N,N-methylenebisacrylamide) is a favorable coating that was imprinted with erythrocytes of different blood groups. In total, 10 MHz quartz sheets with two resonators, one for MIP (molecularly imprinted polymer) and the other for NIP (non-imprinted polymer) were fabricated and later used for mass-sensitive measurements. The structure of erythrocyte imprints resembles a donut, as identified by AFM (atomic force microscope). All the erythrocytes of the ABO system were chosen as templates and the responses to these selective coatings were evaluated against all blood groups. Each blood group can be characterized by the pattern of responses in an unambiguous way. The results for blood group O are remarkable given that all types of erythrocytes give nearly the same result. This can be easily understood as blood group O does not possess neither antigen A nor antigen B. The responses can be roughly related to the number of respective antigens on the erythrocyte surface. The imprints generate hollows, which are used for reversible recognition of the erythrocytes. This procedure is based on molecular recognition (based on supramolecular strategies), which results from size, shape and enthalpic interactions between host and guest molecules.

A Prospective, Randomized Single-Blind Crossover Study Comparing High-Frequency 10,000 Hz and Burst Spinal Cord Stimulation.

OBJECTIVES: Although both high-frequency and burst spinal cord stimulation (SCS) have shown improved efficacy and patient satisfaction compared with conventional tonic stimulation, there are limited data directly comparing the two. This study aimed to compare both high-frequency 10,000 Hz and burst SCS in the same patients in terms of pain relief and satisfaction in those with axial back pain with or without leg pain. MATERIALS AND METHODS: This prospective, single-blind, randomized controlled trial was conducted at an outpatient pain clinic within an academic medical center. Participants were randomly allocated to one of two groups in which they trialed either burst or high-frequency 10,000 Hz SCS over five days, followed by a 24- to 48-hour washout period with no stimulation, and the alternative therapy over the remaining four days. Visual analog scale (VAS) scores were collected immediately before and after both therapy trials. Secondary end points included percentage change in VAS score and patient preference. RESULTS: Of 25 participants, those receiving burst followed by high-frequency SCS (n = 11) had a mean VAS difference of 4.73 after the first trial period and 2.86 after the second. Of those receiving high-frequency followed by burst SCS (n = 14), mean VAS difference after the first trial period was 4.00 and 1.93 after the second trial period. Four participants were withdrawn owing to lead migration. Both therapies showed statistically significant differences in pre- minus post-VAS scores and percent relief. There were no significant differences in carryover or treatment effects between the two groups. There was a statistically significant association between trial sequence and stimulator type implanted because the first stimulator trialed was more likely to be chosen. CONCLUSIONS: There were no observed differences in VAS pain score decrease when comparing burst and high-frequency 10,000 Hz SCS programming therapies. Patient preference followed an order effect, favoring the first programming therapy in the trial sequence.

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

BACKGROUND: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. OBJECTIVE: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. RESULTS: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. CONCLUSION: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354.

A Predictive Model for Pediatric Postoperative Respiratory Failure: A National Inpatient Sample Study.

STUDY OBJECTIVE: To identify risk factors for pediatric postoperative respiratory failure and develop a predictive model. DESIGN: This retrospective case-control study utilized the US National Inpatient Sample (NIS) from 2012 to 2014. Significant predictors were selected, and the predicted probability of pediatric postoperative respiratory failure was calculated. Sensitivity, specificity, and accuracy were then calculated, and receiver-operator curves were drawn. SETTING: National Inpatient Sample data sets from years 2012, 2013, and 2014 were used. PATIENTS: Patients aged 17 and younger in the 2012, 2013, and 2014 NIS data sets. INTERVENTIONS: Candidate predictors included demographic variables, type of surgical procedure, a modified pediatric comorbidity score, presence of substance abuse diagnosis, and presence/absence of kyphoscoliosis. MEASUREMENTS: The primary outcome measure was the pediatric quality indicator (PDI 09), which is defined by the Agency for Healthcare Research Quality, and identifies pediatric patients with postoperative respiratory failure. MAIN RESULTS: The incidence of pediatric postoperative respiratory failure in each year's data set varied from 1.31% in 2012 to 1.41% in 2014. Significant risk factors for the development of postoperative respiratory failure included abdominal surgery ([OR] = 1.92 in 2012 data set, 1.79 in 2013 data set), spine surgery (OR = 7.10 in 2012 data set, 6.41 in 2013 data set), and an elevated pediatric comorbidity score (score of 3 or greater: OR = 32.58 in 2012 data set, 22.74 in 2013 data set). A predictive model utilizing these risk factors achieved a C statistic of 0.82. CONCLUSIONS: Risk factors associated with postoperative respiratory failure in pediatric patients undergoing noncardiac surgery include type of surgery (abdominal and spine) and higher pediatric comorbidity scores. A prediction model based on the identified factors had good predictive ability.

Pain During COVID-19: A Comprehensive Review and Guide for the Interventionalist.

BACKGROUND: Chronic pain, the leading cause of disability in the world, imposes limitations on activities of daily living and diminishes quality of life leading to unnecessary patient suffering. The personal and socioeconomic costs of chronic pain cannot be overstated. Physicians are at the crux of the pandemic and must attempt to limit the spread of the virus while maintaining their professional responsibility to their patients and staff members. OBJECTIVE: The aim of this review is to analyze the existing literature to develop consensus recommendations for treating pain during the current COVID-19 pandemic. METHODS: Relevant literature was located via computer-generated citations between the months of March and May of 2020. Online computer searches of multiple databases including Google Scholar, CINAHL, PubMed, and Cochrane Review were conducted in conjunction with a thorough review of local, state, national, and international governmental and organizational websites to locate research on the area of interest. RESULTS: The guidelines in this review are meant to offer a framework to pain practitioners and organizations for providing highly effective, ethical, and safe care to patients while maintaining their commitment to mitigating the spread of the COVID-19 pandemic. Specific areas addressed include general and interventional-specific treatment and mitigation recommendations. CONCLUSIONS: We believe that the recommendations in this review, if used in conjunction with evolving recommendations of Centers for Disease Control and Prevention (CDC), World Health Organization (WHO), and federal, state, and local governing bodies, provides a path to not only mitigate the spread of the pandemic but also limit the adverse impact of pain and suffering in chronic pain patients.

Conductometric Sensor for PAH Detection with Molecularly Imprinted Polymer as Recognition Layer.

A conductometric sensor based on screen-printed interdigital gold electrodes on glass substrate coated with molecularly imprinted polyurethane layers was fabricated to detect polycyclic aromatic hydrocarbons (PAHs) in water. The results prove that screen-printed interdigital electrodes are very suitable transducers to fabricate low-cost sensor systems for measuring change in resistance of PAH-imprinted layers while exposing to different PAHs. The sensor showed good selectivity to its templated molecules and high sensitivity with a detection limit of 1.3 nmol/L e.g., for anthracene in water which is lower than WHO's permissible limit.

Electrochemical Affinity Biosensors Based on Disposable Screen-Printed Electrodes for Detection of Food Allergens.

Food allergens are proteins from nuts and tree nuts, fish, shellfish, wheat, soy, eggs or milk which trigger severe adverse reactions in the human body, involving IgE-type antibodies. Sensitive detection of allergens in a large variety of food matrices has become increasingly important considering the emergence of functional foods and new food manufacturing technologies. For example, proteins such as casein from milk or lysozyme and ovalbumin from eggs are sometimes used as fining agents in the wine industry. Nonetheless, allergen detection in processed foods is a challenging endeavor, as allergen proteins are degraded during food processing steps involving heating or fermentation. Detection of food allergens was primarily achieved via Enzyme-Linked Immuno Assay (ELISA) or by chromatographic methods. With the advent of biosensors, electrochemical affinity-based biosensors such as those incorporating antibodies and aptamers as biorecognition elements were also reported in the literature. In this review paper, we highlight the success achieved in the design of electrochemical affinity biosensors based on disposable screen-printed electrodes towards detection of protein allergens. We will discuss the analytical figures of merit for various disposable screen-printed affinity sensors in relation to methodologies employed for immobilization of bioreceptors on transducer surface.

Graphene Hybrid Materials in Gas Sensing Applications.

Graphene, a two dimensional structure of carbon atoms, has been widely used as a material for gas sensing applications because of its large surface area, excellent conductivity, and ease of functionalization. This article reviews the most recent advances in graphene hybrid materials developed for gas sensing applications. In this review, synthetic approaches to fabricate graphene sensors, the nano structures of hybrid materials, and their sensing mechanism are presented. Future perspectives of this rapidly growing field are also discussed.

Biomimetic receptors for bioanalyte detection by quartz crystal microbalances - from molecules to cells.

A universal label-free detection of bioanalytes can be performed with biomimetic quartz crystal microbalance (QCM) coatings prepared by imprinting strategies. Bulk imprinting was used to detect the endocrine disrupting chemicals (EDCs) known as estradiols. The estrogen 17ß-estradiol is one of the most potent EDCs, even at very low concentrations. A highly sensitive, selective and robust QCM sensor was fabricated for real time monitoring of 17ß-estradiol in water samples by using molecular imprinted polyurethane. Optimization of porogen (pyrene) and cross-linker (phloroglucinol) levels leads to improved sensitivity, selectivity and response time of the estradiol sensor. Surface imprinting of polyurethane as sensor coating also allowed us to generate interaction sites for the selective recognition of bacteria, even in a very complex mixture of interfering compounds, while they were growing from their spores in nutrient solution. A double molecular imprinting approach was followed to transfer the geometrical features of natural bacteria onto the synthetic polymer to generate biomimetic bacteria. The use of biomimetic bacteria as template makes it possible to prepare multiple sensor coatings with similar sensitivity and selectivity. Thus, cell typing, e.g., differentiation of bacteria strains, bacteria growth profile and extent of their nutrition, can be monitored by biomimetic mass sensors. Obviously, this leads to controlled cell growth in bioreactors.

Posterior Lateral Arthrodesis as a Treatment Option for Lumbar Spinal Stenosis: Safety and Early Clinical Outcomes.

Introduction: Lumbar spinal stenosis (LSS) is a common condition caused by degenerative changes in the lumbar spine with age. LSS is caused by a variety of factors, including degenerative spondylosis and spondylolisthesis. People suffering with LSS experience neurogenic claudication, which causes severe physical limitations, discomfort, and a decrease in quality of life. Less invasive procedures are now being researched to improve the prognosis, success rate, and safety of LSS treatments. Posterior lateral spinal arthrodesis (PLSA) is a new surgical treatment for LSS. This study looks at the procedural and patient safety of PLSA. Materials and methods: This study is a multicenter retrospective analysis of the safety of PLSA who met the clinical indications for PLSA and underwent the procedure at eight interventional spine practices. Data was collected on demographical information, pre-procedural numeric rating scale score (NRS), post-procedural NRS, and complication reporting. Patients who were included had LSS with or without spondylolisthesis and had failed conservative treatments. A descriptive statistical analysis was performed to report the outcomes. Results were reported as mean and standard deviations for continuous outcomes, and frequency (%) for categorical outcomes. Results: This retrospective analysis involved 191 patients and 202 PLSA implants. The majority of patients were male Caucasians with a mean age of 69.2 years and a BMI of 31.1. A large majority of implants were placed at the L4-5 level, and the average pre-procedural NRS was 6.3 while the average post-procedural NRS was 3.1, indicating a 50.8% reduction in pain (p < 0.0001). Two patients reported complications, but they were unrelated to the device or surgical procedure; no infections, device malfunctions, or migrations were reported in the patient cohort. Conclusion: Preliminary results with PLSA implants indicate that it is a safe treatment option for patients with moderate LSS who do not respond to conservative management.

A review of prospective studies regarding percutaneous peripheral nerve stimulation treatment in the management of chronic pain.

Conventionally, peripheral nerve stimulation (PNS) for treatment of chronic pain has involved a two-stage process: a short-term (e.g., 7 days) trial and, if significant pain relief is achieved, a permanent PNS system is implanted. A percutaneous PNS treatment is now available where a coiled lead may be implanted for up to 60 days with the goal of producing sustained relief. In the present review, published prospective trials using percutaneous PNS treatment were identified and synthesized. The collected evidence indicates that percutaneous PNS treatment for up to 60 days provides durable clinically significant improvements in pain and pain interference. Similar efficacy across diverse targets and etiologies supports the broad applicability for use within the chronic pain population using this nonopioid technology.

What is this review about? This review looks at a drug-free way to treat chronic pain called percutaneous peripheral nerve stimulation (PNS). Percutaneous means it is placed through the skin. PNS applies small amounts of electricity to the nerves to reduce chronic pain. Most PNS systems involve a two-step process. A short trial is first performed to see if a patient has pain relief. A permanent system is then placed if the person had pain relief. Percutaneous PNS treatments are different. They use a thin wire called a lead placed in the body for up to 60 days. The lead is taken out at the end of the treatment period. Studies have shown that this type of PNS treatment can reduce chronic pain even after the treatment is over. No previous article has collected all these studies of percutaneous PNS in one place.What evidence was gathered? This review found evidence from studies on treatment of chronic pain. Pain types included shoulder pain, neuropathic pain and low back pain. It found that percutaneous PNS treatment for up to 60 days can reduce pain and how pain interferes with daily life.How can these data lead to better care for patients? These findings mean that percutaneous PNS treatments could be a useful, non-drug option for many types of chronic pain.

Novel Implantation Technique for Thoracoabdominal Peripheral Nerve Stimulation via a Transversus Abdominal Plane Approach for Treatment of Chronic Abdominal Pain.

Background: Chronic abdominal pain (CAP) is a common and challenging to treat condition with a global prevalence of up to 25%. Despite extensive evaluation, approximately 40% of patients with CAP have an unknown diagnosis. Medications may be ineffective, and surgery is rarely indicated. Interventional treatment including sympathetic blocks, sympathetic neurolysis, and transversus abdominal plane (TAP) blocks may be an option, but their efficacy can wane over time. Neuromodulation has emerged as an option for these patients, as there is evidence of success with dorsal column spinal cord and dorsal root ganglion (DRG) stimulation. Peripheral nerve stimulation (PNS) may be an alternative option, particularly in higher risk patients or in patients for whom neuraxial access may be unsafe or too technically challenging. Thoracoabdominal nerve peripheral nerve stimulation via a TAP approach may be more specifically targeted in comparison to dorsal column or DRG stimulation. In this short report, we detail a technique that the authors have successfully used for thoracoabdominal nerve PNS via a TAP approach for management of CAP. Methods: This article describes a novel medial to lateral ultrasound guided thoracoabdominal nerve PNS via a TAP approach technique for lead placement and implantation. Results: A medial to lateral ultrasound guided TAP approach as described to successfully implant percutaneous thoracoabdominal nerve PNS leads for management of CAP. Conclusion: The thoracoabdominal nerve PNS via a TAP approach lead placement technique noted in this report has been used as a means for management of CAP utilizing peripheral neuromodulation. Here, we present a short report detailing a potential technique for PNS utilization for management of CAP. Further studies are needed to validate the safety and efficacy of this therapy modality, although the authors have found it to be a viable management option for patients with medically refractory neuropathic CAP.

Healthcare Utilization (HCU) Reduction with High-Frequency (10 kHz) Spinal Cord Stimulation (SCS) Therapy.

Spinal cord stimulation (SCS) is a well-established treatment for patients with chronic pain. With increasing healthcare costs, it is important to determine the benefits of SCS in healthcare utilization (HCU). This retrospective, single-center observational study involved 160 subjects who underwent implantation of a high-frequency (10 kHz) SCS device. We focused on assessing trends in HCU by measuring opioid consumption in morphine milligram equivalents (MME), as well as monitoring emergency department (ED) and office visits for interventional pain procedures during the 12-month period preceding and following the SCS implant. Our results revealed a statistically significant reduction in HCU in all domains assessed. The mean MME was 51.05 and 26.52 pre- and post-implant, respectively. There was a 24.53 MME overall decrease and a mean of 78.2% statistically significant dose reduction (p < 0.0001). Of these, 91.5% reached a minimally clinically important difference (MCID) in opioid reduction. Similarly, we found a statistically significant (p < 0.01) decrease in ED visits, with a mean of 0.12 pre- and 0.03 post-implant, and a decrease in office visits for interventional pain procedures from a 1.39 pre- to 0.28 post-10 kHz SCS implant, representing a 1.11 statistically significant (p < 0.0001) mean reduction. Our study reports the largest cohort of real-world data published to date analyzing HCU trends with 10 kHz SCS for multiple pain etiologies. Furthermore, this is the first and only study evaluating HCU trends with 10 kHz SCS by assessing opioid use, ED visits, and outpatient visits for interventional pain procedures collectively. Preceding studies have individually investigated these outcomes, consistently yielding positive results comparable to our findings.

Musculoskeletal and Neuropathic Pain in COVID-19.

Chronic pain constitutes a significant disease burden globally and accounts for a substantial portion of healthcare spending. The COVID-19 pandemic contributed to an increase in this burden as patients presented with musculoskeletal or neuropathic pain after contracting COVID-19 or had their chronic pain symptoms exacerbated by the virus. This extensive literature review analyzes the epidemiology of pain pre-pandemic, the costs associated with the COVID-19 pandemic, the impact of the virus on the body, mechanisms of pain, management of chronic pain post-pandemic, and potential treatment options available for people living with chronic pain who have had or are currently infected with COVID-19.

Mixed methodology approach in pharmacy practice research.

Healthcare providers play a major role in attending to all domains of health in a population. In terms of modem healthcare delivery, better health outcomes for population can be achieved by engaging multi-disciplinary expertise. In the last decade, pharmacy profession had transformed tremendously in terms of health and pharmaceutical service provision to both patients and general population. Within this practice transformation, pharmacists, especially those in developed countries, now occupy a respectable position within the healthcare system. In contrast, services and expertise offered by pharmacists in developing countries are still underutilized, and their role as healthcare professionals is not deemed to be important either by the community or by other healthcare providers, especially doctors and nurses. In order to explore the current perspectives regarding the role of pharmacists in the context of a developing country, a systematic research is needed. Mixed methodology research should be used for evidence generation. The philosophy of mixed method research came up decades ago. This approach is widely recommended for social and human sciences research. In recent existence, many researchers have begun to recommend mixed methods research as a separate methodology or design. Many factors have brought into the evolution of mixed methods research. A combination of both forms of data can provide the most complete analysis of the issues related to the pharmacy practice research. Numbers in quantitative and words in qualitative can be enclosed together to give the better understanding of research questions. Both forms of data are necessary for pharmacy practice research especially in case of developing countries where there is a need to generate the evidence for future health policy.

Novel implantation technique for pudendal nerve peripheral nerve stimulation for treatment of chronic pelvic pain.

BACKGROUND: Chronic pelvic pain (CPP) is a pervasive, difficult to treat condition affecting up to 26% of the global female and 8.2% of the global male population. Considered a form of chronic regional pain syndrome (CRPS), it is medically complex and often refractory to multimodal management. Neuromodulation has become increasingly popular in treatment of chronic neuropathic pain conditions, including CPP and CRPS. Dorsal column spinal cord stimulation and dorsal root ganglion stimulation have had some success for managing CPP meanwhile peripheral nerve stimulators (PNS) have been suggested as another viable option. However, few studies in the literature have reported successful use of PNS in treatment of CPP. Here, we detail a possible technique for pudendal PNS lead placement for management of CPP. METHOD: This article describes a novel cephalad to caudad fluoroscopic guided technique for pudendal nerve PNS lead placement and implantation. RESULTS: A cephalad to caudal-medial fluoroscopic guided approach as described within to successfully implant a percutaneous pudendal nerve PNS for management of CPP. CONCLUSIONS: The pudendal nerve PNS lead placement technique noted within can be used to avoid many of the important neurovascular structures near the pelvic outlet. Further studies are needed to validate the safety and efficacy of this therapy modality but it may be a viable management option for patients with medically refractory CPP.

Minimally Invasive Postero-Inferior Sacroiliac Joint Fusion: Surgical Technique and Procedural Details.

(1) Background: Minimally invasive sacroiliac joint (SIJ) fusion is the preferred surgical intervention to treat chronically severe pain associated with SIJ degeneration and dysfunction. (2) Methods: This paper details the ten-step surgical procedure associated with the postero-inferior approach using the PsiF™ DNA Sacroiliac Joint Fusion System. (3) Results: The posterior surgical approach with an inferior operative trajectory (postero-inferior) utilizes easily identifiable landmarks to provide the safest, most direct access to the articular joint space for transfixing device placement. Implanting the device through the subchondral bone provides maximum fixation and stabilization of the joint by utilizing an optimal amount of cortical bone-implant interface. Approaching the joint from the inferior trajectory also places the implant perpendicular to the S1 endplate at a "pivot point" near the sacral axis of rotation, which addresses the most significant motion of the joint. (4) Conclusions: Further observational data from real-world clinical use are encouraged to further validate this procedure as the surgical preference for minimally invasive SIJ fusion.