Celiac plexus block: A diagnostic tool for neurogenic median arcuate ligament syndrome.

OBJECTIVE: The objective of this study was to evaluate the effect of outpatient celiac plexus block on acute pain reduction in patients with suspected median arcuate ligament syndrome. METHODS: This is an Institutional Review Board approved, retrospective chart review. Data were collected and analyzed from patients who received celiac plexus blocks from November 1, 2021 through April 6, 2023. The primary outcome was pain reduction, determined by the change in numerical pain rating scale (NPRS) from pre-procedure to post-procedure. Additional data collected include patient demographics, comorbidities, preoperative symptoms and duration of symptoms. RESULTS: There were 33 patients identified in this study. Thirty-one patients were included in the data analysis. The median age of the cohort was 29 years, and the median BMI was 20.4. 94% of the cohort was female. These patients were referred as part of an evaluation for symptomatic vascular compression disorders. For many patients, positive response to celiac plexus block was used as an indication to proceed with surgical MALS resection. We provide a diagnostic algorithm for MALs. All patients endorsed preoperative symptoms. Patients experienced a median pain reduction of -4 from baseline to immediately post-procedure. CONCLUSIONS: Celiac plexus blocks continue to be a tool for ruling out neurogenic median arcuate ligament syndrome in patients who have undergone extensive previous imaging and assessments for vascular compression disorders. Our data suggest that patients with suspected MALS may experience substantial immediate pain relief from temporary blocks of the celiac ganglion as guided by fluoroscopy in an outpatient setting.

Surgical treatment of refractory low back pain using implanted BurstDR spinal cord stimulation (SCS) in a cohort of patients without options for corrective surgery: Findings and results from the DISTINCT study, a prospective randomized multi-center-controlled trial.

Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. Results: The SCS arm reported an 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.

Evaluating Unmet Needs in Large-Volume Subcutaneous Drug Delivery: US Payer Perspectives on a Novel, Large-Volume On-Body Delivery System.

This research sought to evaluate payer perspectives around OBDS's through semi-structured interviews with 17 US payers representing approximately 227 million covered lives. When asked about the perceived advantages of the novel on-body delivery system (OBDS), 70.6% of payers independently cited simplicity, ease-of-use, and convenience as the most beneficial features, with the potential to replace IV infusion by facilitating at-home HCP- or self-administration being the second most frequent response. Most payers (88.2%) believed that the novel OBDS could fulfill unmet needs such as cost of IV infusion, convenient administration, and improved patient compliance in large-volume SC delivery by enabling safe, easy, self-administration. Nearly all payers (88.2%) stated they would consider covering and managing pharmaceutical products packaged with the novel OBDS, with the remaining payers considering the total cost compared to other routes. A significant proportion of payers (82.4%) acknowledged that a drug delivered via the novel OBDS could warrant a price premium above the cost of the standalone SC drug vial, with half stating the premium would range from 5% to 20% and the other half citing an unspecified premium dependent on the individual drug situation.Conclusions: Given the ability to help address critical unmet needs for the patient and healthcare system, a large proportion of the payers stated that the novel OBDS would fulfill unmet needs and warrant a price premium versus the cost of the standalone SC vial and certainly over the IV counterpart. Future research to quantify the value that OBDS efficiencies could bring to healthcare delivery is warranted.

The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation.

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.

Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial.

BACKGROUND: We report the results from the first large, postmarket, multicentre, randomised controlled trial (RCT) evaluating peripheral nerve stimulation (PNS) for the treatment of chronic peripheral pain with a micro-implantable pulse generator (micro-IPG). METHODS: Subjects meeting eligibility were randomised (2:1) to either the active arm receiving PNS and conventional medical management (CMM) or the control arm receiving CMM alone. Treatments were limited to the following areas: lower back, shoulder, knee and foot/ankle. RESULTS: At 6 months, the active arm achieved an 88% responder rate with a 70% average reduction in pain. At the 3-month primary endpoint, the active arm achieved an 84% responder rate with an average pain reduction of 67% compared with the control arm, which achieved a 3% responder rate with an average pain reduction of 6%. Both responder rate and pain reduction in the active arm were significantly better than in the control arm (p<0.001). A majority of patient-reported outcomes also reached statistical significance. There have been no reports of pocket pain and no serious adverse device effects. 81% of subjects found the external wearable component of the PNS system to be comfortable. CONCLUSIONS: This study successfully reached its primary endpoint-the active arm achieved a statistically significant superior responder rate as compared with the control arm at 3 months. These RCT results demonstrated that PNS, with this micro-IPG, is efficacious and safe. This ongoing study will follow subjects for 3 years, the results of which will be reported as they become available.

Peripheral Nerve Stimulation of the Shoulder: A Technical Primer.

Scapulalgia or shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population and becomes more common as we age. When this pain exceeds 3 months in duration, it is deemed to be chronic, and typically treated in an escalating manner. Spanning a continuum of conservative and non-conservative measures, chronic shoulder pain treatments range from rest and physical therapy to surgery. Since each patient presents with a unique spectrum of symptoms a customized treatment plan is often required. Over the lifetime of many of these patients, a variety of treatment options are required. One of these treatment options, peripheral nerve stimulation (PNS), is a minimally invasive procedure in which an electrical impulse is delivered through a percutaneously implanted, small caliber electrode to a peripheral nerve proximal to the lesion which interferes with the pain signals. Over the past several years, significant growth of PNS in the treatment of chronic neuropathic pain has been observed. However, the procedural techniques have not been well described. The foundation of long-term, minimally invasive percutaneous PNS in patients with chronic shoulder pain, and procedural techniques for stimulating the suprascapular and axillary nerves using fluoroscopy or ultrasonography will be described in this report.

Evaluating unmet needs in large-volume subcutaneous drug delivery: U.S. payer perspectives on a novel, large-volume on-body delivery system.

OBJECTIVE: Existing healthcare systems face finite resource allocation and budgetary constraints, resulting in a substantial need for innovative solutions to enhance service delivery at reduced costs. A novel, user-friendly on-body delivery system (OBDS) was developed which enables administration of large-volume subcutaneous (SC) drugs in both clinical and home-based settings (at-home healthcare professional [HCP] administration or at-home self-administration). METHODS: This research sought to evaluate the potential economic impact of at-home self- or HCP- administration with the OBDS through a comprehensive review of published literature and semi-structured interviews with 17 US payers representing approximately 227 million covered lives. RESULTS: Published literature on OBDS remains limited, but available research highlights the cost-savings of SC administration due to reduced healthcare resource utilization, particularly with home-based care, and improved patient compliance. In interviews, payers identified several attributes that would help address unmet clinical and economic needs. Clinically, the hidden needle and ease-of-use compared to SC syringe pumps was deemed valuable to improve patient compliance and, as OBDS required minimal training, reduce the risk of administration errors. The flexibility to administer drugs at home (self-administration or HCP-administration) or in-clinic was identified as the most impactful attribute on coverage decision making as it has the greatest potential to reduce costs associated with HCP administration for several therapeutic areas. CONCLUSIONS: Given the ability to help address critical unmet needs for the patient and healthcare system, a large proportion of the payers stated that the novel OBDS would warrant a price premium versus the cost of the standalone SC vial and certainly over the IV counterpart. Future research to quantify the value that OBDS efficiencies could bring to healthcare delivery are warranted.

Contemporary approach to cardiogenic shock care: a state-of-the-art review.

Cardiogenic shock (CS) is a time-sensitive and hemodynamically complex syndrome with a broad spectrum of etiologies and clinical presentations. Despite contemporary therapies, CS continues to maintain high morbidity and mortality ranging from 35 to 50%. More recently, burgeoning observational research in this field aimed at enhancing the early recognition and characterization of the shock state through standardized team-based protocols, comprehensive hemodynamic profiling, and tailored and selective utilization of temporary mechanical circulatory support devices has been associated with improved outcomes. In this narrative review, we discuss the pathophysiology of CS, novel phenotypes, evolving definitions and staging systems, currently available pharmacologic and device-based therapies, standardized, team-based management protocols, and regionalized systems-of-care aimed at improving shock outcomes. We also explore opportunities for fertile investigation through randomized and non-randomized studies to address the prevailing knowledge gaps that will be critical to improving long-term outcomes.

Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study.

INTRODUCTION: Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies. METHODS: In this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1-S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0-10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function. RESULTS: 3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001). CONCLUSIONS: In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management. TRIAL REGISTRATION NUMBER: NCT03601949.

Pocket pain following spinal cord stimulator generator implantation: A narrative review of this under-reported risk.

INTRODUCTION: Spinal cord stimulation (SCS) is a well-established treatment option for chronic pain. Pain over the implantable pulse generator, or pocket pain, is an incompletely understood risk of SCS implantation which may limit the efficacy of treatment and patient quality of life. The goal of this narrative review is to analyze the literature to gain a more thorough understanding of the incidence and risk factors for the development of pocket pain to help guide treatment options and minimize its occurrence in the future. METHODS: A literature review was conducted investigating the development of pocket pain in patients with SCS for the management of a variety of pain conditions. RESULTS: In total, 305 articles were included in the original database search and 50 met the criteria for inclusion. The highest level of evidence for papers that specifically investigated pocket pain was level III. Four retrospective, observational analyses included pocket pain as a primary outcome. The remainder of the included studies listed pocket pain as an adverse event of SCS implantation. CONCLUSIONS: There is a relative dearth of primary literature that examines the incidence, characteristics, and health economic implications of pocket pain in patients with SCS. This highlights the need for large-scale, high-quality prospective or randomized controlled trials examining pocket pain. This may ultimately help prevent and reduce pocket pain leading to improved efficacy of treatment and greater patient quality of life.

Bipolar radiofrequency ablation lesion areas and confluence: An ex vivo study and technical report.

INTRODUCTION: Radiofrequency ablation (RFA) has been used for nearly 100 years, treating an array of medical conditions including chronic pain. Radiofrequency (RF) energy depolarizes and repolarizes tissues adjacent to a probe producing heat and causing direct thermal injury. When positioned adjacent to neural structures, it leads to neural tissue injury and cell death interrupting pain signaling with the ultimate goal of providing lasting pain relief. Today, RFA is commonly used to treat cervical, thoracic, and lumbar zygapophyseal joints, sacroiliac joint, and more recently large peripheral joint-mediated pain. There are several applications of RFA systems, including bipolar, conventional thermal, cooled, protruding, and pulsed. As yet, no study has determined the best technical practice for bipolar RFA. OBJECTIVE: This ex vivo study examines RFA lesion midpoint (LMP) area and lesion confluence comparing three different commonly used gauge (g) probes (18-g, 20-g, and 22-g) with 10-mm active tips at various interprobe distances (IPD) to guide best technical practices for its clinical application. METHODS: Bipolar RFA lesions were generated in preservative-free chicken breast specimens using three different gauge probes (18-g, 20-g, and 22-g) with 10-mm active tips at various IPD (6, 8, 10, 12, 14, 16, and 18 mm). RF was applied for 105 s (15-s ramp time) at 80°C for each lesion at both room and human physiological temperature. The specimen tissues were dissected through the lesion to obtain a length, width, and depth, which were used to calculate the LMP area (mm2 ). The LMP areas of each thermal ablation were investigated using visualization and descriptive analysis. The Kruskal-Wallis test was performed to compare LMP areas between the two temperature groups and the three different gauge probe subgroups at the various IPDs. RESULTS: Of the 36 RF lesions (14: 18-g, 12: 20-g, and 10: 22-g) performed, 24 demonstrated lesion confluence. The average time to reach 80°C was 16-17 s; therefore, the average time of RF-energy delivery (at goal temperature) was 88-89 s despite varying needle size or IPD. Comparing the 25 and 37°C groups, 18-g probes produced mean LMP areas of 73.7 and 79.2 mm2 , respectively; 20-g probes produced mean LMP areas of 66 and 66.8 mm2 , respectively; 22-g probes produced mean LMP areas of 56.6 and 59.7 mm2 , respectively. There was no statistical evidence to state a difference regarding LMP area between temperature groups; however, the 18-g probes produced consistently larger LMP areas in the 37°C compared to 25°C specimen groups at each IPD. Lesion confluence was lost for 18-g, 20-g, and 22-g probes at IPD of 14, 12, and 10 mm, respectively, in both 25 and 37°C groups. LMP area was similar between 6 and 8 mm IPD in all of the three-gauge groups; however, there was a significant drop in LMP area from 8 mm IPD to 10 mm and greater. The 18-g, 20-g, and 22-g probes all demonstrated a sharp decline in LMP area when increasing the IPD from 8 to 10 mm. CONCLUSION: This ex vivo technical study evaluated bipolar RFA LMP areas and lesion confluence, and determined the recommended IPD of 18-g, 20-g, and 22-g probes to be less than 12, 10, and 8 mm, respectively, for best clinical practice. Placing bipolar probes at an IPD greater than 14, 12, and 10 mm, respectively, risks the loss of lesion confluence and failure to produce a clinically significant treatment response due to lack of nerve capture. In clinical practice, the use of injectate may produce larger lesions than demonstrated in this study. Additionally, in vivo factors may impact ablation zone size and ablation patterns. As there are a paucity of studies comparing various RFA applications and conventional RFA needles are least expensive, it is possible that bipolar conventional RFA is more cost-effective than other techniques.

Results From a Prospective, Clinical Study (US-nPower) Evaluating a Miniature Spinal Cord Stimulator for the Management of Chronic, Intractable Pain.

BACKGROUND: Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation. OBJECTIVES: We report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG). STUDY DESIGN: This was a single-arm, prospective, multicenter, postmarket, observational study. SETTING: Patients were recruited from 15 US-based comprehensive pain centers. METHODS: This open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured. RESULTS: At baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent  of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG. LIMITATIONS:   Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible. CONCLUSIONS: This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial.

OBJECTIVE: Spinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery. METHODS AND MATERIALS: Patients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis-yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function. RESULTS: Intention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a

How long is too long: A retrospective study evaluating the impact of the duration of noninvasive oxygenation support strategies (high flow nasal cannula & BiPAP) on mortality in invasive mechanically ventilated patients with COVID-19.

BACKGROUND/AIM: We investigated the association of noninvasive oxygenation support [high flow nasal cannula (HFNC) and BiPAP], timing of invasive mechanical ventilation (IMV), and inpatient mortality among patients hospitalized with COVID-19. METHODS: Retrospective chart review study of patients hospitalized with COVID-19 (ICD-10 code U07.1) and received IMV from March 2020-October 2021. Charlson comorbidity index (CCI) was calculated; Obesity defined as body mass index (BMI) ≥ 30 kg/m2; morbid obesity was BMI ≥ 40 kg/m2. Clinical parameters/vital signs recorded at time of admission. RESULTS: 709 COVID-19 patients underwent IMV, predominantly admitted from March-May 2020 (45%), average age 62±15 years, 67% male, 37% Hispanic, and 9% from group living settings. 44% had obesity, 11% had morbid obesity, 55% had type II diabetes, 75% had hypertension, and average CCI was 3.65 (SD = 3.11). Crude mortality rate was 56%. Close linear association of age with inpatient-mortality risk was found [OR (95% CI) = 1.35 (1.27-1.44) per 5 years, p<0.0001)]. Patients who died after IMV received noninvasive oxygenation support significantly longer: 5.3 (8.0) vs. 2.7 (SD 4.6) days; longer use was also independently associated with a higher risk of inpatient-mortality: OR = 3.1 (1.8-5.4) for 3-7 days, 7.2 (3.8-13.7) for ≥8 days (reference: 1-2 days) (p<0.0001). The association magnitude varied between age groups: 3-7 days duration (ref: 1-2 days), OR = 4.8 (1.9-12.1) in ≥65 years old vs. 2.1 (1.0-4.6) in <65 years old. Higher mortality risk was associated with higher CCI in patients ≥65 (P = 0.0082); among younger patients, obesity (OR = 1.8 (1.0-3.2) or morbid obesity (OR = 2.8;1.4-5.9) (p<0.05) were associated. No mortality association was found for sex or race. CONCLUSION: Time spent on noninvasive oxygenation support [as defined by high flow nasal cannula (HFNC) and BiPAP] prior to IMV increased mortality risk. Research for the generalizability of our findings to other respiratory failure patient populations is needed.

Cluneal neuropathy: Background, diagnosis, and treatment.

BACKGROUND AND AIMS: Cluneal neuropathy is encompassed by three distinct clinical entities. Superior, middle, and inferior cluneal neuralgia make up the constellation of symptoms associated with cluneal neuropathy. Each has its own variable anatomy. MATERIALS AND METHODS: We compiled a narrative review including a review of available literature. We conducted searches on PubMed/MEDLINE, Embase and Google Scholar on the topics of cluneal neuropathy and treatment therein. RESULTS: We collected source articles regarding original descriptions of the disease entities in addition to articles focused on treatment. DISCUSSION: Adjusted incidence rates of superior cluneal neuropathy are 1.6%-11.7%. Accurate diagnosis remains challenging due to the lack of standardized criteria and the aforementioned variability. Treatment may include therapeutic nerve blocks, ablative techniques, neuromodulation, and surgical decompression. Gaps including those related to true incidence and work up exist. Outcomes from interventional studies are limited and mixed due to significant population heterogeneity and non-standardized treatment approaches coupled with very small sample sizes.

A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain.

OBJECTIVES: The aim of this article is to discuss the possible mechanisms of action (MOAs) and results of a pilot study of a novel, anatomically placed, and paresthesia-independent, neurostimulation waveform for the management of chronic intractable pain. MATERIALS AND METHODS: A novel, multilayered pulsed stimulation pattern (PSP) that comprises three temporal layers, a Pulse Pattern layer, Train layer, and Dosage layer, was developed for the treatment of chronic intractable pain. During preliminary development, the utility was evaluated of anatomical PSP (aPSP) in human subjects with chronic intractable pain of the leg(s) and/or low back, compared with that of traditional spinal cord stimulation (T-SCS) and physiological PSP. The scientific theory and testing presented in this article provide the preliminary justification for the potential MOAs by which PSP may operate. RESULTS: During the pilot study, aPSP (n = 31) yielded a greater decrease in both back and leg pain than did T-SCS (back: -60% vs -46%; legs: -63% vs -43%). In addition, aPSP yielded higher responder rates for both back and leg pain than did T-SCS (61% vs 48% and 78% vs 50%, respectively). DISCUSSION: The novel, multilayered approach of PSP may provide multimechanistic therapeutic relief through preferential fiber activation in the dorsal column, optimization of the neural onset response, and use of both the medial and lateral pathway through the thalamic nuclei. The results of the pilot study presented here suggest a robust responder rate, with several subjects (five subjects with back pain and three subjects with leg pain) achieving complete relief from PSP during the acute follow-up period. These clinical findings suggest PSP may provide a multimechanistic, anatomical, and clinically effective management for intractable chronic pain. Because of the limited sample size of clinical data, further testing and long-term clinical assessments are warranted to confirm these preliminary findings.

Physical Therapy Considerations and Recommendations for Patients Following Spinal Cord Stimulator Implant Surgery.

OBJECTIVES: Spinal cord stimulation (SCS) is an established therapy option in interventional pain medicine. Recent advances in technology have allowed for greater compliance with treatment and improved efficacy in pain control. This article was proposed to fill the gap in the literature addressing this specific patient population and to facilitate further research. Even though there is a lack of consensus among societies and experts on exact parameters of physical therapy (PT) considerations and postoperative limitations in patients with SCS, we propose rehabilitative care for this population should be standardized. As the number of patients with SCS implants grow, it is vital to understand how to appropriately approach patients with implantable devices when additional treatments such as PT are prescribed. MATERIALS AND METHODS: A literature search was performed on the use of PT following SCS implantation. Presently, there is no literature to date which addresses the use of PT in this patient population. The lack of data is the largest hurdle in the creation of formal SCS therapy guidelines. The authors therefore proposed recommendations for rehabilitation based upon a detailed understanding of SCS hardware alongside well-studied physiotherapy concepts. RESULTS: Considerations when initiating PT in the SCS patient population should include: 1) biomechanics and quality of SCS output; 2) therapeutic exercise and spinal manipulation in association with risk for lead migration and fracture; 3) the application of therapeutic modalities and risk for injury to the patient and/or damage to the SCS componentry; and 4) integration of a biopsychosocial, person-centered approach. CONCLUSIONS: PT treatment protocol in patients with a recently implanted SCS device should be person-centered addressing individual needs, values, and goals. Further research is needed to fully appreciate the impact of an interprofessional approach to management of SCS patients, particularly following stimulator implantation.

A Standardized and Regionalized Network of Care for Cardiogenic Shock.

BACKGROUND: The benefits of standardized care for cardiogenic shock (CS) across regional care networks are poorly understood. OBJECTIVES: The authors compared the management and outcomes of CS patients initially presenting to hub versus spoke hospitals within a regional care network. METHODS: The authors stratified consecutive patients enrolled in their CS registry (January 2017 to December 2019) by presentation to a spoke versus the hub hospital. The primary endpoint was 30-day mortality. Secondary endpoints included bleeding, stroke, or major adverse cardiovascular and cerebrovascular events. RESULTS: Of 520 CS patients, 286 (55%) initially presented to 34 spoke hospitals. No difference in mean age (62 years vs 61 years; P = 0.38), sex (25% vs 32% women; P = 0.10), and race (54% vs 52% white; P = 0.82) between spoke and hub patients was noted. Spoke patients more often presented with acute myocardial infarction (50% vs 32%; P < 0.01), received vasopressors (74% vs 66%; P = 0.04), and intra-aortic balloon pumps (88% vs 37%; P < 0.01). Hub patients were more often supported with percutaneous ventricular assist devices (44% vs 11%; P < 0.01) and veno-arterial extracorporeal membrane oxygenation (13% vs 0%; P < 0.01). Initial presentation to a spoke was not associated with increased risk-adjusted 30-day mortality (adjusted OR: 0.87 [95% CI: 0.49-1.55]; P = 0.64), bleeding (adjusted OR: 0.89 [95% CI: 0.49-1.62]; P = 0.70), stroke (adjusted OR: 0.74 [95% CI: 0.31-1.75]; P = 0.49), or major adverse cardiovascular and cerebrovascular events (adjusted OR 0.83 [95% CI: 0.50-1.35]; P = 0.44). CONCLUSIONS: Spoke and hub patients experienced similar short-term outcomes within a regionalized CS network. The optimal strategy to promote standardized care and improved outcomes across regional CS networks merits further investigation.