The percutaneous technique of electrode insertion in the vicinity of the greater occipital nerves to treat occipital neuralgia was first described in the 1990s by Weiner and Reed. This subsequently ...stimulated awareness of peripheral nerve stimulation (PNS). The more recent advent emergence of a minimally invasive percutaneous approach by way of using ultrasound has further increased the interest in PNS as a viable alternative to more invasive techniques. PNS has become more popular recently and is increasingly used to treat various pain conditions. Its foundation is fundamentally based on the gate control theory, although the precise mechanism underlying its analgesic effect is still indefinite. Studies have demonstrated the peripheral and central analgesic mechanisms of PNS by modulating the inflammatory pathways, the autonomic nervous system, the endogenous pain inhibition pathways, and the involvement of the cortical and subcortical areas. Peripheral nerve stimulation exhibits its neuromodulatory effect both peripherally and centrally. Further understanding of the modulation of PNS mechanisms can help guide stimulation approaches and parameters to optimize the use of PNS. his chapter aims to review the background and mechanisms of PNS modulation. PNS is becoming one of the most diverse therapies in neuromodulation due to rapid evolution and expansion. It is an attractive option for clinicians due to the simplicity and versatility of procedures that can be combined with other neuromodulation treatments or used alone. It has a distinct role in the modulation of functional conditions.
Epidural injections have been used since 1901 in managing low back pain and sciatica. Spinal pain, disability, health, and economic impact continue to increase, despite numerous modalities of ...interventions available in managing chronic spinal pain. Thus far, systematic reviews performed to assess the efficacy of epidural injections in managing chronic spinal pain have yielded conflicting results.
To evaluate and update the clinical utility of the efficacy of epidural injections in managing chronic spinal pain.
A systematic review of randomized controlled trials of epidural injections in managing chronic spinal pain.
In this systematic review, randomized trials with a placebo control or an active-control design were included. The outcome measures were pain relief and functional status improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Best evidence synthesis was conducted based on the qualitative level of evidence (Level I to V). Data sources included relevant literature identified through searches of PubMed for a period starting in 1966 through August 2015; Cochrane reviews; and manual searches of the bibliographies of known primary and review articles.
A total of 52 trials met inclusion criteria. Meta-analysis was not feasible. The evidence in managing lumbar disc herniation or radiculitis is Level II for long-term improvement either with caudal, interlaminar, or transforaminal epidural injections with no significant difference among the approaches. The evidence is Level II for long-term management of cervical disc herniation with interlaminar epidural injections. The evidence is Level II to III in managing thoracic disc herniation with an interlaminar approach. The evidence is Level II for caudal and lumbar interlaminar epidural injections with Level III evidence for lumbar transforaminal epidural injections for lumbar spinal stenosis. The evidence is Level III for cervical spinal stenosis management with an interlaminar approach. The evidence is Level II for axial or discogenic pain without facet arthropathy or disc herniation treated with caudal or lumbar interlaminar injections in the lumbar region; whereas it is Level III in the cervical region treated with cervical interlaminar epidural injections. The evidence for post lumbar surgery syndrome is Level II with caudal epidural injections and for post cervical surgery syndrome it is Level III with cervical interlaminar epidural injections.
Even though this is a large systematic review with inclusion of a large number of randomized controlled trials, the paucity of high quality randomized trials literature continues to confound the evidence.
This systematic review, with an assessment of the quality of manuscripts and outcome parameters, shows the efficacy of epidural injections in managing a multitude of chronic spinal conditions.
For decades, epidural steroid injections have been an effective tool in the management of many pain related conditions, including lumbar radiculopathy. Transforaminal epidural steroid injections in ...particular have been reported to potentially result in central nervous system infarctions which have not been reported with interlaminar epidural steroid injections, while providing comparable efficacy. This rare, catastrophic complication has been attributed by some authors to be due to vascular injury secondary to vasospasm, thrombus formation, dissection, as well as concerns with placing the needle at the so-called "safe triangle." Others, however, have proposed it to be secondary to embolization of the vessel by particulate steroids. This has led to the recommendation of the use of soluble steroids such as dexamethasone when performing TFESI's, despite concerns over its efficacy and potential for neurotoxicity in the literature. Furthermore, there have also been multiple studies which have revealed that IV dexamethasone is analgesic and that peri-neural dexamethasone is no more effective than IV dexamethasone.
The present case involves a 60-year-old patient with right back and radicular leg pain for 3 years. Two right L4 TFESI's had been performed with betamethasone several years prior with satisfactory results, until the patient presented to the physician with a pain recurrence of 6 weeks of duration. The patient again underwent a right L4 TFESI with dexamethasone, which provided good relief after 2 weeks. The patient underwent a repeat right L4 TFESI with dexamethasone which was followed by a prompt onset of lower extremity numbness, weakness, and incontinence that was discovered to be related to a conus infarction. While this is the first publicly reported case of a conus medullaris infarction following a lumbar transforaminal injection utilizing dexamethasone, the incidence of these reports may rise as the prevalence of dexamethasone use increases in clinical practice.
The spinal cord infarction with TFESI's may occur related to various mechanisms, regardless of the type of particulate or non-particulate steroid used during these procedures.
Chronic pain management during the coronavirus disease 2019 (COVID-19) pandemic is a challenging process, especially with growing evidence that COVID-19 infection is associated with myalgias, ...referred pain, and widespread hyperalgesia. In light of the limited data available for COVID-19-related impact on chronic pain patients, this review explores the changes in the healthcare delivery system due to social distancing and safety precautions to provide the appropriate management of chronic pain patients during the COVID-19 pandemic. Understanding both the general problems facing chronic pain patients as well as specific problems in the COVID-19 era including deconditioning, increased mental health concerns, financial burdens, and potential for medication-induced immune-suppression is vital in the appropriate management of patients. Telemedicine, the practice of caring for patients remotely when the provider and patient are not physically present with each other, is becoming increasingly used and recognized as a valuable tool to both health care providers and patients. This paper concentrates on the proper utilization of the available resources to help patients with the most severe conditions as well as the most vulnerable group. COVID-19 may be associated with a profound effect on both the health care system and patients with chronic pain. As a result, delaying, or stopping, treatment for chronic pain patients will have negative consequences, and strong pain evaluations must be administered to triage patients appropriately. Recent recommendations for the safe use of non-opioid analgesics, opioid analgesics, and interventional pain management procedures are vital to know and understand specifically during the pandemic era. Further researches are needed to identify the advance planning and rapid responses to reduce the impact of the pandemic.
The therapeutic spinal facet joint interventions generally used for the treatment of axial spinal pain of facet joint origin are intraarticular facet joint injections, facet joint nerve blocks, and ...radiofrequency neurotomy. Despite interventional procedures being common as treatment strategies for facet joint pathology, there is a paucity of literature investigating these therapeutic approaches. Systematic reviews assessing the effectiveness of various therapeutic facet joint interventions have shown there to be variable evidence based on the region and the modality of treatment utilized. Overall, the evidence ranges from limited to moderate.
To evaluate and update the clinical utility of therapeutic lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain.
A systematic review of therapeutic lumbar, cervical, and thoracic facet joint interventions for the treatment of chronic spinal pain.
The available literature on lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain was reviewed. The quality assessment criteria utilized were the Cochrane Musculoskeletal Review Group criteria and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for randomized trials and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) for observational studies. The level of evidence was classified at 5 levels from Level I to Level V. Data sources included relevant literature identified through searches on PubMed and EMBASE from 1966 through March 2015, and manual searches of the bibliographies of known primary and review articles.
The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake consumption.
A total of 21 randomized controlled trials meeting appropriate inclusion criteria were assessed in this evaluation. A total of 5 observational studies were assessed. In the lumbar spine, for long-term effectiveness, there is Level II evidence for radiofrequency neurotomy and lumbar facet joint nerve blocks, whereas the evidence is Level III for lumbosacral intraarticular injections. In the cervical spine, for long-term improvement, there is Level II evidence for cervical radiofrequency neurotomy and cervical facet joint nerve blocks, and Level IV evidence for cervical intraarticular injections. In the thoracic spine there is Level II evidence for thoracic facet joint nerve blocks and Level IV evidence for radiofrequency neurotomy for long-term improvement.
The limitations of this systematic review include an overall paucity of high quality studies and more specifically the lack of investigations related to thoracic facet joint injections.
Based on the present assessment for the management of spinal facet joint pain, the evidence for long-term improvement is Level II for lumbar and cervical radiofrequency neurotomy, and therapeutic facet joint nerve blocks in the cervical, thoracic, and lumbar spine; Level III for lumbar intraarticular injections; and Level IV for cervical intraarticular injections and thoracic radiofrequency neurotomy.
The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for ...better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine.
The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine.
The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature.RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions.• The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III.• Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique.Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities.Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use.Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs.
Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use.
Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.
The pharmacological management of dental pain Pergolizzi, Joseph V.; Magnusson, Peter; LeQuang, Jo Ann ...
Expert opinion on pharmacotherapy,
03/2020, Volume:
21, Issue:
5
Journal Article
Peer reviewed
Dental pain is primarily treated by dentists and emergency medicine clinicians and may occur because of insult to the tooth or oral surgery. The dental impaction pain model (DIPM) has been widely ...used in clinical studies of analgesic agents and is generalizable to many other forms of pain.
The authors discuss the DIPM, which has allowed for important head-to-head studies of analgesic agents, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and combinations. Postsurgical dental pain follows a predictable trajectory over the course of one to 3 days. Dental pain may have odontic origin or may be referred pain from other areas of the body.
Pain following oral surgery has sometimes been treated with longer-than-necessary courses of opioid therapy. Postsurgical dental pain may be moderate to severe but typically resolves in a day or two after the extraction. Opioid monotherapy, rarely used in dentistry but combination therapy (opioid plus acetaminophen or an NSAID), was sometimes used as well as nonopioid analgesic monotherapy. The dental impaction pain model has been valuable in the study of analgesics but does not address all painful conditions, for example, pain with a neuropathic component.
Interlaminar and transforaminal epidural steroid injections (ILESI and TFESI) are commonly performed procedures. However, the United States Food and Drug Administration has required the addition of ...drug warning labels for injectable corticosteroids. Updated evidence and scrutiny from regulatory agencies may affect practice patterns.
To characterize TFESI practices as well as to provide an update on periprocedural practices for any type of epidural steroid injection (ESI), we surveyed pain medicine physicians in the United States.
This was a cross-sectional survey of pain medicine physicians in the United States.
A web-based survey was distributed to pain medicine physicians in the United States selected from the Accreditation Council for Graduate Medical Education accredited pain medicine fellowship program list as well as the American Society of Interventional Pain Physicians membership database. Physicians were queried about TFESI practices, including needle size, use of image guidance, methods to detect vascular uptake, and preference for injectate.
A total of 249 responses were analyzed. Only a minority of respondents reported performing cervical TFESI. There were variations in needle size, methods to detect vascular uptake, and choice of injectate. There were also variations in monitoring practices.
The response rate is a limitation. Thus the results may not be representative of all US pain medicine physicians.
Though all respondents used image guidance for TFESI, variations in other TFESI practices exist. There are also differences in periprocedural practices. Since the closure of this survey, a multisociety pain workgroup published recommendations regarding ESI practices. Our survey findings support the need for more evidence-based guidelines regarding ESI.
Epidrual steroid injections, transforaminal epidural steroid injection, steroids, local anesthetic, survey, interventional pain.
Epidural injections are among the most commonly performed procedures for managing low back and lower extremity pain. Pinto et al and Chou et al previously performed systematic reviews and ...meta-analyses, which, along with a recent update from Oliveira et al showing the lack of effectiveness of epidural steroid injections in managing lumbar disc herniation, spinal stenosis, and radiculopathy. In contrast to these papers, multiple other systematic reviews and meta-analyses have supported the effectiveness and use of epidural injections utilizing fluoroscopically guided techniques. A major flaw in the review can be related to attributing active-controlled trials to placebo-controlled trials. The assumption that local anesthetics do not provide sustained benefit, despite extensive evidence that local anesthetics provide long-term relief, similar to a combination of local anesthetic with steroids is flawed.
The Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy were reanalyzed using systematic methodology and meta-analysis.
To re-evaluate Cochrane data on RCTs of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy utilizing qualitative and quantitative techniques with dual-arm and single-arm analysis.
In this systematic review, we have used the same RCTs from the Cochrane Review of a minimum of 20% change in pain scale or significant pain relief of >= 50%. The outcome measures were pain relief and functional status improvement. Significant improvement was defined as 50% or greater pain relief and functional status improvement. Our review was performed utilizing the Cochrane Review methodologic quality assessment and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing the principles of best evidence synthesis and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. Clinical relevance of the pragmatic nature of each study was assessed.
In evaluating the RCTs in the Cochrane Review, 10 trials were performed with fluoroscopic guidance. Utilizing conventional dual-arm and single-arm meta-analysis, the evidence is vastly different from the interpretation of the data within the Cochrane Review. The overall combined evidence is Level I, or strong evidence, at one and 3 months, and Level II, or moderate evidence, at 6 and 12 months.
The limitation of this study is that only data contained in the Cochrane Review were analyzed.
A comparative systematic review and meta-analysis of the Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy yielded different results. This review, based on the evidence derived from placebo-controlled trials and active-controlled trials showed Level I, or strong evidence, at one and 3 months and Level II at 6 and 12 months. This review once again emphasizes the importance of the allocation of studies to placebo-control and active-control groups, utilizing standards of practice with inclusion of only the studies performed under fluoroscopic guidance.
Multiple publications have shown the significant impact of the COVID-19 pandemic on US healthcare and increasing costs over the recent years in managing low back and neck pain as well as other ...musculoskeletal disorders. The COVID-19 pandemic has affected many modalities of treatments, including those related to chronic pain management, including both interventional techniques and opioids. While there have not been assessments of utilization of interventional techniques specific to the ongoing COVID-19 pandemic, previous analysis published with data from 2000 to 2018 demonstrated a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 fee-for-service (FFS) in the Medicare population. During that same time, the Medicare population has grown by 3% annually.
The objectives of this analysis include an evaluation of the impact of the COVID-19 pandemic, as well as an updated assessment of the utilization of interventional techniques in managing chronic pain in the Medicare population from 2010 to 2019, 2010 to 2020, and 2019 to 2020 in the FFS Medicare population of the United States.
Utilization patterns and variables of interventional techniques with the impact of the COVID-19 pandemic in managing chronic pain were assessed from 2000 to 2020 in the FFS Medicare population of the United States.
The data for the analysis was obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2020.
The results of the present investigation revealed an 18.7% decrease in utilization of all interventional techniques per 100,000 Medicare beneficiaries from 2019 to 2020, with a 19% decrease for epidural and adhesiolysis procedures, a 17.5% decrease for facet joint interventions and sacroiliac joint blocks, and a 25.4% decrease for disc procedures and other types of nerve blocks. The results differed from 2000 to 2010 with an annualized increase of 10.2% per 100,000 Medicare population compared to an annualized decrease of 0.4% from 2010 to 2019, and a 2.5% decrease from 2010 to 2020 for all interventional techniques. For epidural and adhesiolysis procedures decreases were more significant and annualized at 3.1% from 2010 to 2019, increasing the decline to 4.8% from 2010 to 2020. For facet joint interventions and sacroiliac joint blocks, the reversal of growth patterns was observed but maintained at an annualized rate increase of 2.1% from 2010 to 2019, which changed to a decrease of 0.01% from 2010 to 2020. Disc procedures and other types of nerve blocks showed similar patterns as epidurals with an 0.8% annualized reduction from 2010 to 2019, which was further reduced to 3.6% from 2010 to 2020 due to COVID-19.
Data for the COVID-19 pandemic impact were available only for 2019 and 2020 and only the FFS Medicare population was utilized; utilization patterns in Medicare Advantage Plans, which constitutes almost 40% of the Medicare enrollment in 2020 were not available. Moreover, this analysis shares the limitations present in all retrospective reviews of claims based datasets.
The decline driven by the COVID-19 pandemic was 18.7% from 2019 to 2020. Overall decline in utilization in interventional techniques from 2010 to 2020 was 22.0% per 100,000 Medicare population, with an annual diminution of 2.5%, despite an increase in the population rate of 3.3% annualized (38.9% overall) and Medicare enrollees of 33.4% and 2.9% annually.
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