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

First Human Report of Relief of Lumbar and Cervical Discogenic and Arthritic Back Pain after Epidural and Facet Joint Mesenchymal Stem Cell Injection: A Case Report.

INTRODUCTION: Back pain causes tremendous patient suffering and high financial cost to the healthcare system. Mesenchymal Stem Cells (MSCs) have demonstrated the ability to enhance healing and reduce inflammation and pain without the deleterious side effects of corticosteroids and nonsteroidal anti-inflammatory drugs in numerous clinical series for peripheral joint arthritis. We hypothesized that translaminar MSC injection into the epidural space would effectively treat disc arthritis without the burden of sedation and the risks of disc space injection. We further hypothesized that MSC injection into the facet joints would effectively and safely treat facet joint-induced back pain. The combination of epidural and facet joint injection would potentially treat the most recognized low back pain generators with virtually complete safety. OBJECTIVE: We present the initial results for the first patient enrolled in phase 1 clinical trial of the efficacy and safety of allogeneic MSCs when injected translaminarly and into the facet joints for the treatment of recalcitrant discogenic and arthritic back pain. CASE REPORT: A 47-year-old male presented with complaints of 13-year-long chronic lower back pain resistant to conservative treatment. The decision was made to treat the patient with umbilical cord-derived MSCs. 87 million MSCs were infused intravenously. Simultaneously, 1 million cells were injected into each of the 8 lumbar epidural facet joints and 5 million cells into the lumbar epidural space. The patient had no adverse events or complications related to the treatment. Five days after treatment, most of his lumbar pain was gone, and his back spasms stopped. He no longer needed to take acetaminophen or ibuprofen and had no difficulty sleeping without medications. The patient also reported his residual cervical radicular pain to be 98% resolved due to the injection. CONCLUSION: We have demonstrated for the first time that MSC injection into the lumbar facet joints and epidural space results in significant improvement of lower back pain and can improve symptoms in other spinal regions without engendering the risks associated with intradiscal injections or epidural use of corticosteroids.

Circadian pain patterns in human pain conditions - A systematic review.

BACKGROUND: Chronobiology is the science of how physiological processes in the body follow a pattern of time. Pain has been shown to follow a circadian rhythm, with different types of pain having variable expression along this rhythm. OBJECTIVE: This article reviews the nature of diurnal variations in pain along with a discussion of the mechanisms of circadian rhythm of pain. EVIDENCE REVIEW: We conducted a literature search on the PubMed and Google Scholar electronic databases, through April 2022. Publications were screened for English language, full-text availability, and human subjects. Randomized controlled trials and observational trials were included. Data were extracted from studies on patients with acute or chronic pain phenotypes, which provide pain severity data and corresponding diurnal time points. FINDINGS: The literature search led to the inclusion of 39 studies. A circadian pattern of pain was found to be present in nociceptive, neuropathic, central, and mixed pain states. Postoperative pain, fibromyalgia, trigeminal neuralgia, and migraines were associated with higher pain scores in the morning. Temporomandibular joint pain, neuropathic pain, labor pain, biliary colic, and cluster headaches increased throughout the day to reach a peak in the evening or night. Arthritis and cancer pain were not associated with any circadian rhythmicity. Furthermore, the circadian rhythm of pain was not found to be altered in patients on analgesics. CONCLUSION: The results of this review suggest that an understanding of diurnal variation may help improve therapeutic strategies in pain management, for instance through analgesic titration.

Identifying molecular mechanisms of acute to chronic pain transition and potential drug targets.

INTRODUCTION: Chronic pain is pain that lasts more than the normal physiologic healing time at the time of initial insult. The transition from acute to chronic pain has been studied thoroughly. Understanding the mechanisms underlying chronic pain formation is essential for the development of novel treatments and therapeutics for chronic pain prevention. AREA COVERED: The transition from acute to chronic pain has been associated with the intracellular changes caused by repeated stimulus application, or neuronal priming, allowing for the chronicity of pain. Ongoing research studies have shown this priming to occur at various sites along the pathway for the neural transmission of pain. The purpose of this review is to not only elucidate the transition from acute to chronic pain and discuss current studies/trials related to this transition but also to highlight mechanisms involved in the process that could serve as potential targets for chronic pain prevention. EXPERT OPINION: We are providing an overview of novel treatment strategies for preventing the transition from acute to chronic pain. A multifaceted and multimodal approach that invokes multiple targets, at least one from each section (the periphery, the spinal cord, and the brain), would be the best option for tackling this problem.

Dehiscence and Deep Wound Infection After Spinal Cord Stimulator Implant Managed Without Explantation: A Case Report.

Deep infections of spinal cord stimulator devices usually result in explantation, as recommended by some professional societies. However, alternative options should be explored to avoid potential complications that are associated with explantation, and possibly additional procedures required in consideration of reimplantation. In this case, the patient presented with wound dehiscence after implantation. There was suspicion for deep wound infection based on a wound culture that was positive for Staphylococcus aureus, but no purulent material was noted on further inspection. The patient was treated with standard wound-care management and oral antibiotics without removing the device, and recovered while preserving the original system.

Overcoming clinical challenges of refractory neuropathic pain.

INTRODUCTION: Refractory neuropathic pain (ReNP), and its definition, is widely disputed among clinicians due in part to unclear diagnosing guidelines, overall duration of neuropathic pain, and the exhaustiveness of treatment options. Usually, ReNP is defined as chronic, intractable, and unresponsive neuropathic pain that has otherwise been untreatable. AREAS COVERED: In this narrative review, we discuss and summarize the effectiveness of prospective ReNP research conducted over the past 10 years. This research looks at pharmacological and interventional therapies in clinical trial settings. The pharmacological therapies discussed include the use of adjuvant treatments to improve the safety and efficacy of conventional approaches. Different modalities of administration, such as injection therapy and intrathecal drug delivery systems, provide targeted drug delivery. Interventional therapies such as neuromodulation, pulse radiofrequency, and nerve lesioning are more invasive; however, they are increasingly utilized in the field, as reflected in ongoing clinical trials. EXPERT OPINION: Based on the current data from RCTs and systematic reviews, it is clear that single drug therapy cannot be effective and has significant limitations. Transitioning to interventional modalities that showed more promising results sooner rather than later may be even more cost efficient than attempting different conservative treatments with a high failure rate.

Utility of Cervical Sympathetic Block in Treating Post-Traumatic Stress Disorder in Multiple Cohorts: A Retrospective Analysis.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a prevalent and debilitating condition in the United States. Success rates for evidence-based therapies are inconsistent, and many suffer in silence due to the stigmata associated with seeking traditional mental health care. This has led clinicians to explore new therapeutic options, with cervical sympathetic blockade (CSB), performed at the stellate and/or superior cervical ganglion levels, recently emerging as a promising treatment option. Rapid therapeutic onset, improved compliance, and high clinical efficacy rates have made this an attractive approach for both providers and patients. However, to date, CSB as a treatment of PTSD has primarily been used in male patients with military-related trauma. OBJECTIVE: To evaluate the efficacy of CSB as a treatment option for PTSD in both genders and multiple etiologies of psychological trauma. STUDY DESIGN: Retrospective cohort study. SETTING: An established anesthesia pain clinic in Chicago, IL, USA. METHODS: Following retroactive IRB approval, 484 consecutive cases of patients diagnosed with PTSD and treated with CSB, performed by a single provider (December 2016 - February 2020) were analyzed. The primary outcome measurement was the PTSD Checklist Score version DSM IV (PCL-4). Patient demographic and clinical information collected included age, gender, type of trauma leading to PTSD, history of suicidal attempts, and psychiatric medication use. RESULTS: After exclusion of cases due to missing data points, 327 patients were included in the final statistical analysis, having completed both PCL-4 pre and post CSB, between 7- and 30-days post-intervention. The patient population included military men (n = 97), civilian men (n = 85), military women (n = 13) and civilian women (n = 132). We identified 21 types of self-reported trauma leading to PTSD. Average decrease in PCL score for men and women was 28.59 and 29.2, respectively. Statistical analysis of the male population with a military background showed a significantly greater change in corresponding PCL scores than civilians (PCL-M change = -31.83 vs PCL-C change = -24.89). Likewise, women who had a military background had a significantly greater reduction in PCL score than civilians (39.15 vs 28.23). Statistically significant improvements in PTSD symptoms were noted independent of the causative trauma type, gender, age greater than 20, previous suicide attempts, or use of prescription medications for PTSD. Among the 21 types of reported trauma, 19 types reached statistical significance. LIMITATIONS: Limitations include the limited scope of observation giving exclusive focus on pre- and post-PCL data, the limited duration of observation, the self-reported nature of the patient-provided data, and the provision of treatment by a single physician. CONCLUSION: CSB seems to be an effective treatment for PTSD symptoms irrespective of gender, trauma type, PTSD-related drug use, suicide attempt, or age.

No Differences in Pain Scores and Treatment Response in Patients from Different Socioeconomic Areas Within the City of Chicago.

BACKGROUND: It is well established that the experience of chronic pain significantly differs among ethnic-racial groups. There is mixed evidence to suggest that societal influences may contribute to pain prevalence among cultural groups and their treatment response. One possible explanation for differences in pain experience are the differences in socioeconomic status among patients with chronic pain. OBJECTIVE: To determine whether there is any difference in pain scores or treatment responses among patients with different socioeconomic status. STUDY DESIGN: Retrospective analysis. SETTING: Outpatient pain clinic. METHODS: After approval from the Advocate Healthcare Institutional Review Board, we included 1,149 patients treated for different chronic pain conditions who were followed for at least 12 months. Patients were stratified into quartiles determined by median income according to ZIP code. RESULTS: Of the sampled patients, 207 patients lived in ZIP codes with median incomes > $51,294; 515 in ZIP codes with median incomes between $40,083 and $51,294; 332 in ZIP  codes with median incomes between $30,625 and $40,083; and 95 in ZIP codes with median incomes < $30,625. Groups differed in age (P = 0.047), race (P < 0.001), body mass index (BMI) (P = 0.019), utilization of opioid medications (P = 0.011), morphine milligram equivalents (MME) on first visit (P = 0.036), and utilization of membrane stabilizers such as gabapentin (P = 0.019). There were no significant differences among groups in terms of gender (P = 0.531), type of pain experienced (P = 0.679), or time since pain onset (P = 0.174). Groups were treated similarly, with no statistically significant differences in the proportions of patients who had taken various nonopioid medications throughout their treatment course other than membrane stabilizers, the number of patients who received interventional pain management procedures, or MME at last visit. Average pretreatment numeric rating scale pain scores were not significantly different among quartiles (P = 0.079), posttreatment pain scores (P = 0.767), and subjective percent improvement (P = 0.434). LIMITATIONS: This is a single center study and may have limitations in extrapolating to the general population. CONCLUSION: The results of our study show that there are no differences in pain perception or treatment responses in patients from different socioeconomic statuses despite differences among groups in age, BMI, race, utilization of opioid medications, and MME at first visit. Patients at this pain practice appear to have been treated with similar modalities regardless of socioeconomic status.

Left Ventricular Strain Rate for Intraoperative Evaluation of Cardiac Diastolic Function by Transesophageal Echocardiography: The Correlation Between Late Diastolic Peak Longitudinal Strain Rate and the Severity of Diastolic Dysfunction.

OBJECTIVES: Speckle-tracking echocardiography is a promising tool for evaluating cardiac diastolic dysfunction. A correlation between left atrial strain rate during atrial contraction and the severity of diastolic dysfunction previously has been demonstrated. Because visualization of the left atrial walls is difficult with transesophageal echocardiography, the authors evaluated the use of left ventricular strain rate during atrial contraction as a substitute for left atrial strain rate to intraoperatively measure the extent of cardiac diastolic dysfunction. DESIGN: Retrospective clinical study. SETTING: Single institutional study. PARTICIPANTS: Sixty-six patients who underwent cardiac surgery between January 2018 and January 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Preoperative echocardiographic reports and intraoperative echocardiographic images of the participants were studied. The correlation of cardiac diastolic dysfunction stage with the peak longitudinal strain rate during late diastole and the time to peak value were evaluated. The late diastolic peak longitudinal strain rate was correlated significantly with the stage of diastolic dysfunction (r = -0.64, p < 0.0001). There was no significant correlation between the stage of diastolic dysfunction and the time to peak value (r = -0.17, p = 0.18). A late diastolic peak longitudinal strain rate <0.68 1/s had a sensitivity of 80% and specificity of 81% for predicting grade 2 or 3 diastolic dysfunction. CONCLUSIONS: The late diastolic peak longitudinal strain rate correlates with the severity of diastolic dysfunction in patients undergoing cardiac surgery.

Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study.

STUDY DESIGN: Prospective, international, multicenter, single-arm, post-market study. OBJECTIVE: The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261). SUMMARY OF BACKGROUND DATA: Passive recharge burst spinal cord stimulation (B-SCS) uniquely mimics neuronal burst firing patterns in the nervous system and has been shown to modulate the affective and attentional components of pain processing. METHODS: After a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months. RESULTS: Significant improvements in physical, mental, and emotional functioning observed after 6 months of treatment were maintained at 2 years. Pain catastrophizing scale (PCS) scores dropped below the population norm. Health-related quality of life on EQ-5D improved across all domains and the mean index score was within one standard deviation of norm. Pain reduction (on NRS) was statistically significant (P < 0.001) at all timepoints. Patient reported pain relief, a stated percentage of improvement in pain, was consistent at all timepoints at 60%. Patients reported significant improvements across all measures including activity levels and impact of pain on daily life. At 24 months, 84% of subjects were satisfied and 90% would recommend the procedure. Subjects decreased their chronic pain medication intake for all categories; 38% reduced psychotropic and muscle relaxants, 46% reduced analgesic, anti-convulsant and NSAIDs, and 48% reduced opioid medication. Adverse events occurred at low rates without unanticipated events. CONCLUSION: Early positive results with B-SCS were maintained long term. Evidence across multiple assessment tools show that B-SCS can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life.Level of Evidence: 3.

A novel checklist for anesthesia in neurosurgical cases.

Throughout their training, anesthesiology residents are exposed to a variety of surgical subspecialties, many of which have specific anesthetic considerations. According to the Accreditation Council for Graduate Medical Education requirements, each anesthesiology resident must provide anesthesia for at least twenty intracerebral cases. There are several studies that demonstrate that checklists may reduce deficiencies in pre-induction room setup. We are introducing a novel checklist for neuroanesthesia, which we believe to be helpful for residents during their neuroanesthesiology rotations. Our checklist provides a quick and succinct review of neuroanesthetic challenges prior to case setup by junior residents, covering noteworthy aspects of equipment setup, airway management, induction period, intraoperative concerns, and postoperative considerations. We recommend displaying this checklist on the operating room wall for quick reference.

Low back pain.

Low back pain covers a spectrum of different types of pain (eg, nociceptive, neuropathic and nociplastic, or non-specific) that frequently overlap. The elements comprising the lumbar spine (eg, soft tissue, vertebrae, zygapophyseal and sacroiliac joints, intervertebral discs, and neurovascular structures) are prone to different stressors, and each of these, alone or in combination, can contribute to low back pain. Due to numerous factors related to low back pain, and the low specificity of imaging and diagnostic injections, diagnostic methods for this condition continue to be a subject of controversy. The biopsychosocial model posits low back pain to be a dynamic interaction between social, psychological, and biological factors that can both predispose to and result from injury, and should be considered when devising interdisciplinary treatment plans. Prevention of low back pain is recognised as a pivotal challenge in high-risk populations to help tackle high health-care costs related to therapy and rehabilitation. To a large extent, therapy depends on pain classification, and usually starts with self-care and pharmacotherapy in combination with non-pharmacological methods, such as physical therapies and psychological treatments in appropriate patients. For refractory low back pain, a wide range of non-surgical (eg, epidural steroid injections and spinal cord stimulation for neuropathic pain, and radiofrequency ablation and intra-articular steroid injections for mechanical pain) and surgical (eg, decompression for neuropathic pain, disc replacement, and fusion for mechanical causes) treatment options are available in carefully selected patients. Most treatment options address only single, solitary causes and given the complex nature of low back pain, a multimodal interdisciplinary approach is necessary. Although globally recognised as an important health and socioeconomic challenge with an expected increase in prevalence, low back pain continues to have tremendous potential for improvement in both diagnostic and therapeutic aspects. Future research on low back pain should focus on improving the accuracy and objectivity of diagnostic assessments, and devising treatment algorithms that consider unique biological, psychological, and social factors. High-quality comparative-effectiveness and randomised controlled trials with longer follow-up periods that aim to establish the efficacy and cost-effectiveness of low back pain management are warranted.

Combination of the T7 Unilateral Erector Spinae Plane Block and T10 Bilateral Retrolaminar Blocks in a Patient with Multiple Rib Fractures on the Right and T10-12 Vertebral Compression Fractures: A Case Report.

Multiple vertebral compression and rib fractures in elderly patients with pre-existing chronic obstructive pulmonary disease is a common scenario associated with significant morbidity and mortality. Severe pain prevents normal ventilation and leads to atelectasis, consolidation, and pneumonia. Subsequently, these patients frequently develop respiratory failure and require intubation and critical care. Therefore, adequate analgesia is often a life-saving intervention. Anesthetic management of a 78-year-old kyphotic patient with T6, T7, and T9 rib fractures on the right and T10-12 vertebral compression fractures sustained in an accidental fall is presented. She had inadequate pain control and was unable to take a deep breath or cough. Her respiratory status was deteriorating, with tachypnea and worsening hypoxia, necessitating bi-level positive airway pressure (BiPAP) support. Since thoracic epidural analgesia was contraindicated owing to compressive vertebral fractures and to the pending respiratory failure, we opted for a unilateral erector spinae plane (ESP) block at the T7 level and bilateral retrolaminar (RL) blocks at the T10 level. Following the procedure, the pain was immediately relieved and the patient was able to take deep breaths. Shortly thereafter, her respiratory status improved, with the respiratory rate coming back close to the baseline. The patient was subsequently weaned from BiPAP support and discharged from the intensive care unit. While the combination of ESP and RL blocks is not routinely used in patients with multiple rib and vertebral compression fractures, our report indicates that it may be an excellent alternative for analgesia in situations where thoracic epidural and/or paravertebral blocks are contraindicated and when timely intervention could be potentially life-saving.

Comparative safety review of current treatment options for chronic low back pain and unmet needs: a narrative review.

Introduction: The healthcare expenditures in the United States are substantial for the management of refractory, chronic low back pain (CLBP). The objective of this review is to summarize and evaluate the safety profiles of different pharmacological treatment options used in the management of CLBP.Areas covered: The authors conducted a search of randomized controlled trials (RCTs) assessing the safety profiles of different pharmacological agents used in the management of CLBP. This narrative review covered corticosteroids, opioids, antidepressants, gabapentinoids, nonsteroidal anti-inflammatory drugs, muscle relaxants, anti-nerve growth factor antibodies and topical agents, as monotherapy or in combination.Expert opinion: The risk-benefit ratio of a particular treatment is a subject driving the ongoing development of pharmaceuticals. The most commonly reported AEs across all drug classes are of gastrointestinal nature, followed by neurological and skin-related. These AEs include nausea, dizziness, constipation, arthralgia, headache, dry mouth, pruritus, etc. The majority of the AEs reported are not life-threatening, although they may lower patients' quality of life, thus, affecting their compliance. One of the biggest limitations of our review stems from the paucity of safety assessments in published RCTs. Advances in our understanding of the neurobiology of pain will promote development of new therapeutic strategies.

Herbal Medicine for Pain Management: Efficacy and Drug Interactions.

Complementary and alternative medicines such as herbal medicines are not currently part of the conventional medical system. As the popularity of and global market for herbal medicine grows among all age groups, with supporting scientific data and clinical trials, specific alternative treatments such as herbal medicine can be reclassified as a practice of conventional medicine. One of the most common conditions for which adults use herbal medicine is pain. However, herbal medicines carry safety concerns and may impact the efficacy of conventional therapies. Unfortunately, mechanisms of action are poorly understood, and their use is unregulated and often underreported to medical professionals. This review aims to compile common and available herbal medicines which can be used as an alternative to or in combination with conventional pain management approaches. Efficacy and safety are assessed through clinical studies on pain relief. Ensuing herb-drug interactions such as cytochrome modulation, additive and synergistic effects, and contraindications are discussed. While self-management has been recognized as part of the overall treatment strategy for patients suffering from chronic pain, it is important for practitioners to be able to also optimize and integrate herbal medicine and, if warranted, other complementary and alternative medicines into their care.

Insulin Resistance is Associated with Central Pain in Patients with Fibromyalgia.

BACKGROUND: Insulin resistance (IR) is a pathological condition in which cells fail to respond normally to insulin. IR has been associated with multiple conditions, including chronic pain. Fibromyalgia (FM) is one of the common generalized chronic painful conditions with an incidence rate affecting 3% to 6% of the population. Substantial interest and investigation into FM continue to generate  many hypotheses.The relationship between IR and FM has not been explored. IR is known to cause abnormalities in the cerebral microvasculature, leading to focal hypoperfusion. IR also has been shown to cause cognitive impairment in FM patients, as in parkinsonism. As demonstrated by advanced imaging methods, similar brain perfusion abnormalities occur in the brain of patients with FM as with IR. OBJECTIVES: To determine the potential association between FM and IR. SETTING: Subspecialty pain medicine clinics. STUDY DESIGN: Observational cross-sectional study. METHODS: Laboratory data was extracted through a retrospective review of medical records from patients who had met the American College of Rheumatology (ACR) criteria for FM. The Hemoglobin A1c (HbA1c) values from 33 patients with FM were compared with the means of the glycated HbA1c levels of 2 control populations. In addition, established indices of IR [Quantitative Insulin Sensitivity Check Index (QUICKI) and the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)] were calculated in a subgroup of patients in whom the analytes necessary for these calculations were available. To assess for confounding factors, the associations between HbA1c, QUICKI, HOMA-IR, fasting insulin levels, and glucose, after controlling for age, were explored by multiple analyses of variance with relation to gender and ethnicity. RESULTS: We found an association between IR and FM that was independent of age, gender, and ethnicity. We found that patients with FM belong to a distinct population that can be segregated from the control groups by their HbA1c levels, a surrogate marker of IR. This was demonstrated by analyzing the data after introducing an age correction into a linear regression model. This strategy showed significant differences between patients with FM and control subjects (P < 0.0001 and P  = 0.0002, for 2 separate control populations, respectively). A subgroup analysis using the QUICKI and HOMA-IR showed that all patients with FM in this subgroup (100%) exhibited laboratory abnormalities pointing to IR. LIMITATIONS: Small observational cross-sectional study. There are also intrinsic limitations that are attributed to cross-sectional studies. CONCLUSION: The association demonstrated in this study warrant further investigation, including the pursuit of randomized, double-blind clinical trials to determine the effect of improving insulin sensitivity in FM related pain scores. Such studies could unveil a potential pathogenetic relationship between FM, central pain, and IR. Based on these initial findings, we present the hypothesis that IR may underlie pathological mechanisms leading to central pain. If confirmed, this may lead to a paradigm shift in the management of central pain.

A Retrospective Analysis of Gabapentinoid and Opioids to Opioid Monotherapy for Pain Relief in Patients with Chronic Neck and Low Back Pain.

OBJECTIVE: We compared the reduction in pain and opioid consumption in patients with chronic spinal pain on concomitant gabapentinoids and opioids with patients using opioids only. DESIGN: This was a retrospective chart review of patients with chronic neck or low back pain who were on opioids with at least a 24-month follow-up. SETTING: Single-center pain clinic in an urban setting. SUBJECTS: 167 patients with chronic spinal pain lasting at least six months. METHODS: Patients on gabapentin or pregabalin were included in the gabapentinoid group, while the other patients were included in the non-gabapentinoid group. Primary outcome was assessment of pain scores measured via a numeric rating scale (NRS), and secondary outcomes were response to the treatment (>2 point reduction on NRS) and daily opioid use measured in morphine milliequivalents. RESULTS: Pain scores were reduced in the first six months and plateaued after that in both groups. At the end of 24 months, the average pain score was 6.71 in the gabapentinoid group, while the average pain score was 7.18 in the non-gabapentinoid group. There was no statistical significance between the groups (p = 0.28). There was no difference in response to treatment in gabapentinoid group (33.3%) when compared with non-gabapentinoid group (32.7%). We also failed to find any significant difference in daily opioid usage between the two groups. CONCLUSION: Gabapentinoids may not lead to reduction in pain or opioid consumption in patients with chronic spinal pain. A careful approach must be adopted while prescribing gabapentinoids in the chronic spinal pain patient population.

Methodology for Evidence Synthesis and Development of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain.

BACKGROUND: The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, "clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." The revised definition distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria. OBJECTIVE: To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. METHODS: A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations. RESULTS: Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence. This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews. LIMITATIONS: Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques. CONCLUSION: This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.