Do Corticosteroid Injections for the Treatment of Pain Influence the Efficacy of Adenovirus Vector-Based COVID-19 Vaccines?

MYTH: Corticosteroid injection for the treatment of pain is known to decrease the efficacy of the adenovirus vector-based vaccines for COVID-19. FACT: There is currently no direct evidence to suggest that a corticosteroid injection before or after the administration of an adenovirus vector-based COVID-19 vaccine decreases the efficacy of the vaccine. However, based on the known timeline of hypothalamic-pituitary-adrenal axis suppression following epidural and intraarticular corticosteroid injections, and the timeline of the reported peak efficacy of the Janssen and AstraZeneca vaccines, physicians should consider timing an elective corticosteroid injection such that it is administered no less than 2 weeks prior to and no less than 2 weeks following a COVID-19 adenovirus vector-based vaccine dose, whenever possible. We emphasize the importance of risk/benefit analysis and shared decision making in determining the timing of corticosteroid injections for pain indications in relation to receipt of a COVID-19 vaccine given that patient-specific factors will vary.

Do Corticosteroid Injections for the Treatment of Pain Influence the Efficacy of mRNA COVID-19 Vaccines?

MYTH: Corticosteroid injection for the treatment of pain and inflammation is known to decrease the efficacy of the messenger ribonucleic acid (mRNA) vaccines for coronavirus disease 2019 (COVID-19). FACT: There is currently no direct evidence to suggest that a corticosteroid injection before or after the administration of an mRNA COVID-19 vaccine decreases the efficacy of the vaccine.However, based on the known timeline of hypothalamic-pituitary-adrenal (HPA) axis suppression following epidural and intraarticular corticosteroid injections, and the timeline of the reported peak efficacy of the Pfizer-BioNTech and Moderna vaccines, physicians should consider timing an elective corticosteroid injection such that it is administered no less than 2 weeks prior to a COVID-19 mRNA vaccine dose and no less than 1 week following a COVID-19 mRNA vaccine dose, whenever possible.

The Effectiveness of Lumbar Transforaminal Injection of Steroid for the Treatment of Radicular Pain: A Comprehensive Review of the Published Data.

OBJECTIVE: To determine the effectiveness of lumbar transforaminal injection of steroid for the treatment of radicular pain. DESIGN: Comprehensive systematic review. OUTCOME MEASURES: The primary outcome of interest was the proportion of individuals with reduction of pain by ≥50%. Additional outcomes of interest were a more-than-two-point reduction in pain score, patient satisfaction, functional improvement, decreased use of pain medication, and avoidance of spinal surgery. RESULTS: For patients with disc herniations, using the criterion of ≥50% reduction in pain, success rates across included studies (range) were 63% (58-68%) at one month, 74% (68-80%) at three months, 64% (59-69%) at six months, and 64% (57-71%) at one year. For patients with lumbar spinal stenosis, success rates across included studies (range) were 49% (43-55%) at one month, 48% (35-61%) at three months, 43% (33-53%) at six months, and 59% (45-73%) at one year, but there was a lack of corroboration from appropriately controlled studies. CONCLUSIONS: There is strong evidence that lumbar transforaminal injection of steroids is an effective treatment for radicular pain due to disc herniation. There is a lack of high-quality evidence demonstrating their effectiveness for the treatment of radicular pain due to spinal stenosis, though small studies suggest a possible benefit. Lumbar transforaminal injection of nonparticulate steroids is as effective as injections with particulate steroids.

Pain Management Best Practices from Multispecialty Organizations During the COVID-19 Pandemic and Public Health Crises.

BACKGROUND: It is nearly impossible to overestimate the burden of chronic pain, which is associated with enormous personal and socioeconomic costs. Chronic pain is the leading cause of disability in the world, is associated with multiple psychiatric comorbidities, and has been causally linked to the opioid crisis. Access to pain treatment has been called a fundamental human right by numerous organizations. The current COVID-19 pandemic has strained medical resources, creating a dilemma for physicians charged with the responsibility to limit spread of the contagion and to treat the patients they are entrusted to care for. METHODS: To address these issues, an expert panel was convened that included pain management experts from the military, Veterans Health Administration, and academia. Endorsement from stakeholder societies was sought upon completion of the document within a one-week period. RESULTS: In these guidelines, we provide a framework for pain practitioners and institutions to balance the often-conflicting goals of risk mitigation for health care providers, risk mitigation for patients, conservation of resources, and access to pain management services. Specific issues discussed include general and intervention-specific risk mitigation, patient flow issues and staffing plans, telemedicine options, triaging recommendations, strategies to reduce psychological sequelae in health care providers, and resource utilization. CONCLUSIONS: The COVID-19 public health crisis has strained health care systems, creating a conundrum for patients, pain medicine practitioners, hospital leaders, and regulatory officials. Although this document provides a framework for pain management services, systems-wide and individual decisions must take into account clinical considerations, regional health conditions, government and hospital directives, resource availability, and the welfare of health care providers.

Guidelines for Composing and Assessing a Paper on the Treatment of Pain: A Practical Application of Evidence-Based Medicine Principles to the Mint Randomized Clinical Trials.

Objective: To perform a thorough assessment of the recently published Mint Trials in order to illustrate how to read and analyze a study critically, according to principles of evidence-based medicine. Design: Narrative review. Method: We have applied the recently published guidelines for composing and assessing studies on the treatment of pain to a recently published article describing a large study that claimed its "findings do not support the use of radiofrequency denervation to treat chronic low back pain." These guidelines describe the critical components of a high-quality manuscript that allows communication of all relevant information from authors to readers. Results: Application of evidence-based medicine principles to the publication describing the Mint Trials reveals significant issues with the methodology and conclusions drawn by the authors. A thorough assessment demonstrates issues with inclusion/exclusion criteria, diagnostic block protocols, radiofrequency neurotomy technique, co-interventions, outcome measurement, power analysis, study sample characteristics, data analysis, and loss to follow-up. A failure to definitively establish a diagnosis, combined with use of an inadequate technique for radiofrequency neurotomy and numerous other methodological flaws, leaves the reader unable to draw meaningful conclusions from the study data. Conclusions: Critical analysis, rooted in principles of evidence-based medicine, must be employed by writers and readers alike in order to encourage transparency and ensure that appropriate conclusions are drawn from study data.

Influence of Mild Traumatic Brain Injury (TBI) and Posttraumatic Stress Disorder (PTSD) on Pain Intensity Levels in OEF/OIF/OND Veterans.

OBJECTIVE: Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are common among US veterans of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND). We postulated that these injuries may modulate pain processing in these individuals and affect their subjective pain levels. DESIGN: Cross-sectional. SUBJECTS: 310 deployed service members of OEF/OIF/OND without a lifetime history of moderate or severe TBI were included in this study. METHODS: All participants completed a comprehensive evaluation for Blast Exposure, mTBI, PTSD, and Pain Levels. The Boston Assessment of TBI-Lifetime Version (BAT-L) was used to assess blast exposure and potential brain injury during military service. The Clinician-Administered PTSD Scale (CAPS) characterized presence and severity of PTSD. The Visual Analog Scale (VAS) was used to assess pain intensity over the previous month before the interview, with higher scores indicative of worse pain. Statistical analysis was performed by ANOVA and results were adjusted for co-morbidities, clinical characteristics and demographic data. RESULTS: In comparison to control participants (veterans without mTBI or current PTSD), veterans with both current PTSD and mTBI reported the highest pain intensity levels, followed by veterans with PTSD only (P < 0.0001 and P = 0.0005, respectively). Pain levels in veterans with mTBI only were comparable to control participants. CONCLUSIONS: Comorbid PTSD and mTBI is associated with increased self-reported pain intensity. mTBI alone was not associated with increased pain.

The Effectiveness and Risks of Non-Image-Guided Lumbar Interlaminar Epidural Steroid Injections: A Systematic Review with Comprehensive Analysis of the Published Data.

OBJECTIVE: To determine the effectiveness and risks of non-image-guided lumbar interlaminar epidural steroid injections. DESIGN: Systematic review. INTERVENTIONS: Three reviewers with formal training and certification in evidence-based medicine searched the literature on non-image-guided lumbar interlaminar epidural steroid injections. A larger team of seven reviewers independently assessed the methodology of studies found and appraised the quality of the evidence presented. OUTCOME MEASURES: The primary outcome assessed was pain relief. Other outcomes such as functional improvement, reduction in surgery rate, decreased use of opioids, and complications were noted, if reported. The evidence was appraised in accordance with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system of evaluating evidence. RESULTS: The searches yielded 92 primary publications addressing non-image-guided lumbar interlaminar epidural steroid injections. The evidence supporting the effectiveness of these injections for pain relief and functional improvement in patients with lumbar radicular pain due to disc herniation or neurogenic claudication secondary to lumbar spinal stenosis is limited. This procedure may provide short-term benefit in the first 3-6 weeks. The small number of case reports on significant risks suggests these injections are relatively safe. In accordance with GRADE, the quality of evidence is very low. CONCLUSIONS: In patients with lumbar radicular pain secondary to disc herniation or neurogenic claudication due to spinal stenosis, non-image-guided lumbar interlaminar epidural steroid injections appear to have clinical effectiveness limited to short-term pain relief. Therefore, in a contemporary medical practice, these procedures should be restricted to the rare settings where fluoroscopy is not available.

An Expedited Diagnostic Algorithm for Lumbosacral Pain: "The Best Likelihood Scenario Approach".

INTRODUCTION: The logic behind diagnostic blocks is very straightforward. What has not been determined is the way diagnostic blocks can be best used. STUDY DESIGN: Philosophical essay. DISCUSSION: The interventional pain management physician would serve as the diagnostic expert by efficiently determining the source of the patient's pain. CONCLUSION: "The Best Likelihood Scenario" might improve diagnostic accuracy while decreasing societal costs.

Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections.

BACKGROUND: In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. RESULTS: The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message.

Lumbar zygapophysial (facet) joint radiofrequency denervation success as a function of pain relief during diagnostic medial branch blocks: a multicenter analysis.

BACKGROUND CONTEXT: The publication of several recent studies showing minimal benefit for radiofrequency (RF) lumbar zygapophysial (l-z) joint denervation have led many investigators to reevaluate selection criteria. One controversial explanation for these findings is that the most commonly used cutoff value for selecting patients for l-z (facet) joint RF denervation, greater than 50% pain relief after diagnostic blocks, is too low and hence responsible for the high failure rate. PURPOSE: To compare l-z joint RF denervation success rates between the conventional greater than or equal to 50% pain relief threshold and the more stringently proposed greater than or equal to 80% cutoff for diagnostic medial branch blocks (MBB). STUDY DESIGN/SETTING: Multicenter, retrospective clinical data analysis. PATIENT SAMPLE: Two hundred and sixty-two patients with chronic low back pain who underwent l-z RF denervation at three pain clinics. OUTCOME MEASURES: Outcome measures were greater than 50% pain relief based on visual analog scale or numerical pain rating score after RF denervation persisting at least 6 months postprocedure, and global perceived effect (GPE), which considered pain relief, satisfaction and functional improvement. METHODS: Data were garnered at three centers on 262 patients who underwent l-z RF denervation after obtaining greater than or equal to 50% pain relief after diagnostic MBB. Subjects were separated into those who received partial (greater than or equal to 50% but less than 80%) and near-complete (greater than or equal to 80%) pain relief from the MBB. Outcomes between groups were compared with multivariate analysis after controlling for 14 demographic and clinical variables. RESULTS: One hundred and forty-five patients obtained greater than or equal to 50% but less than 80% pain relief after diagnostic MBB, and 117 patients obtained greater than or equal to 80% relief. In the greater than or equal to 50% group, success rates were 52% and 67% based on pain relief and GPE, respectively. Among patients who experienced greater than 80% relief from diagnostic blocks, 56% obtained greater than or equal to 50% relief from RF denervation and 66% had a positive GPE. CONCLUSIONS: Using more stringent pain relief criteria when selecting patients for l-z joint RF denervation is unlikely to improve success rates, and may lead to misdiagnosis and withholding a potentially valuable treatment from good candidates.