Comparison of the Efficacy of Caudal, Interlaminar, and Transforaminal Epidural Injections in Managing Lumbar Disc Herniation: Is One Method Superior to the Other?

Background: Epidural injections are performed utilizing 3 approaches in the lumbar spine: caudal, interlaminar, and transforaminal. The literature on the efficacy of epidural injections has been sporadic. There are few high-quality randomized trials performed under fluoroscopy in managing disc herniation that have a long-term follow-up and appropriate outcome parameters. There is also a lack of literature comparing the efficacy of these 3 approaches. Methods: This manuscript analyzes data from 3 randomized controlled trials that assessed a total of 360 patients with lumbar disc herniation. There were 120 patients per trial either receiving local anesthetic alone (60 patients) or local anesthetic with steroids (60 patients). Results: Analysis showed similar efficacy for caudal, interlaminar, and transforaminal approaches in managing chronic pain and disability from disc herniation. The analysis of caudal epidural injections showed the potential superiority of steroids compared with local anesthetic alone a 2-year follow-up, based on the average relief per procedure. In the interlaminar group, results were somewhat superior for pain relief in the steroid group at 6 months and functional status at 12 months. Interlaminar epidurals provided improvement in a significantly higher proportion of patients. The proportion of patients nonresponsive to initial injections was also lower in the group for local anesthetic with steroid in the interlaminar trial. Conclusions: The results of this assessment show significant improvement in patients suffering from chronic lumbar disc herniation with 3 lumbar epidural approaches with local anesthetic alone, or using steroids with long-term follow-up of up to 2 years, in a contemporary interventional pain management setting

Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids

Therapeutic opioid use and abuse coupled with the nonmedical use of other psychotherapeutic drugs has shown an explosive growth in recent years and has been a topic of great concern and controversy. Americans, constituting only 4.6% of the world's population, have been consuming 80% of the global opioid supply, and 99% of the global hydrocodone supply, as well as two-thirds of the world's illegal drugs. With the increasing therapeutic use of opioids, the supply and retail sales of opioids are mirrored by increasing abuse in patients receiving opioids, nonmedical use of other psychotherapeutic drugs (in this article the category of psychotherapeutics includes pain relievers, tranquilizers, stimulants, and sedatives, but does not include over-the-counter drugs), emergency department visits for prescription controlled drugs, exploding costs, increasing incidence of side effects, and unintentional deaths. However, all these ills of illicit drug use and opioid use, abuse, and non-medical use do not stop with adults. It has been shown that 80% of America's high school students, or 11 million teens, and 44% of middle school students, or 5 million teens, have personally witnessed, on the grounds of their schools, illegal drug use, illegal drug dealing, illegal drug possession, and other activities related to drug abuse. The results of the 2006 National Survey on Drug Use and Health showed that 7.0 million or 2.8% of all persons aged 12 or older had used prescription type psychotherapeutic drugs nonmedically in the past month, 16.387 million, or 6.6% of the population, had used in the past year, and 20.3%, or almost 49.8 million, had used prescription psychotherapeutic drugs nonmedically during their lifetime. Sadly, the initiates of psychotherapeutic drugs used for nonmedical purposes were highest for opioids. Therapeutic opioid use has increased substantially, specifically of Schedule II drugs. Apart from lack of effectiveness (except for short-term, acute pain) there are multiple adverse consequences including hormonal and immune system effects, abuse and addiction, tolerance, and hyperalgesia. Patients on long-term opioid use have been shown to increase the overall cost of healthcare, disability, rates of surgery, and late opioid use

Retrospective cohort study of usage patterns of epidural injections for spinal pain in the US fee-for-service Medicare population from 2000 to 2014

Objective: To assess the usage patterns of epidural injections for chronic spinal pain in the fee-for-service (FFS) Medicare population from 2000 to 2014 in the USA. Design: A retrospective cohort. Methods: The descriptive analysis of the administrative database from Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) master data from 2000 to 2014 was performed. The guidance from Strengthening the Reporting of Observational studies in Epidemiology (STROBE) was applied. Analysis included multiple variables based on the procedures, specialties and geography. Results: Overall epidural injections increased 99% per 100 000 Medicare beneficiaries with an annual increase of 5% from 2000 to 2014. Lumbar interlaminar and caudal epidural injections constituted 36.2% of all epidural injections, with an overall decrease of 2% and an annual decrease of 0.2% per 100 000 Medicare beneficiaries. However, lumbosacral transforaminal epidural injections increased 609% with an annual increase of 15% from 2000 to 2014 per 100 000 Medicare population. Conclusions: Usage of epidural injections increased from 2000 to 2014, with a decline thereafter. However, an escalating growth has been seen for lumbosacral transforaminal epidural injections despite numerous reports of complications and regulations to curb the usage of transforaminal epidural injections

Cost Utility Analysis of Cervical Therapeutic Medial Branch Blocks in Managing Chronic Neck Pain

Background:Controlled diagnostic studies have established the prevalence of cervical facet joint pain to range from 36% to 67% based on the criterion standard of ≥ 80% pain relief. Treatment of cervical facet joint pain has been described with Level II evidence of effectiveness for therapeutic facet joint nerve blocks and radiofrequency neurotomy and with no significant evidence for intraarticular injections. However, there have not been any cost effectiveness or cost utility analysis studies performed in managing chronic neck pain with or without headaches with cervical facet joint interventions. Study Design:Cost utility analysis based on the results of a double-blind, randomized, controlled trial of cervical therapeutic medial branch blocks in managing chronic neck pain. Objectives:To assess cost utility of therapeutic cervical medial branch blocks in managing chronic neck pain. Methods: A randomized trial was conducted in a specialty referral private practice interventional pain management center in the United States. This trial assessed the clinical effectiveness of therapeutic cervical medial branch blocks with or without steroids for an established diagnosis of cervical facet joint pain by means of controlled diagnostic blocks. Cost utility analysis was performed with direct payment data for the procedures for a total of 120 patients over a period of 2 years from this trial based on reimbursement rates of 2016. The payment data provided direct procedural costs without inclusion of drug treatments. An additional 40% was added to procedural costs with multiplication of a factor of 1.67 to provide estimated total costs including direct and indirect costs, based on highly regarded surgical literature. Outcome measures included significant improvement defined as at least a 50% improvement with reduction in pain and disability status with a combined 50% or more reduction in pain in Neck Disability Index (NDI) scores. Results:The results showed direct procedural costs per one-year improvement in quality adjusted life year (QALY) of United States Dollar (USD) of $2,552, and overall costs of USD$4,261. Overall, each patient on average received 5.7 ± 2.2 procedures over a period of 2 years. Average significant improvement per procedure was 15.6 ± 12.3 weeks and average significant improvement in 2 years per patient was 86.0 ± 24.6 weeks. Limitations:The limitations of this cost utility analysis are that data are based on a single center evaluation. Only costs of therapeutic interventional procedures and physician visits were included, with extrapolation of indirect costs. Conclusion:The cost utility analysis of therapeutic cervical medial branch blocks in the treatment of chronic neck pain non-responsive to conservative management demonstrated clinical effectiveness and cost utility at USD $4,261 per one year of QALY

Explosive growth of facet joint interventions in the medicare population in the United States: a comparative evaluation of 1997, 2002, and 2006 data

<p>Abstract</p> <p>Background</p> <p>The Office of Inspector General of the Department of Health and Human Services (OIG-DHHS) issued a report which showed explosive growth and also raised questions of lack of medical necessity and/or indications for facet joint injection services in 2006.</p> <p>The purpose of the study was to determine trends of frequency and cost of facet joint interventions in managing spinal pain.</p> <p>Methods</p> <p>This analysis was performed to determine trends of frequency and cost of facet joint</p> <p>Interventions in managing spinal pain, utilizing the annual 5% national sample of the Centers for</p> <p>Medicare and Medicaid Services (CMS) for 1997, 2002, and 2006.</p> <p>Outcome measures included overall characteristics of Medicare beneficiaries receiving facet joint interventions, utilization of facet joint interventions by place of service, by specialty, reimbursement characteristics, and other variables.</p> <p>Results</p> <p>From 1997 to 2006, the number of patients receiving facet joint interventions per 100,000</p> <p>Medicare population increased 386%, facet joint visits increased 446%, and facet joint interventions increased 543%. The increases were higher in patients aged less than 65 years compared to those 65 or older with patients increasing 504% vs. 355%, visits increasing 587% vs. 404%, and services increasing 683% vs. 498%.</p> <p>Total expenditures for facet joint interventions in the Medicare population increased from over $229 million in 2002 to over$511 million in 2006, with an overall increase of 123%. In 2006, there was a 26.8-fold difference in utilization of facet joint intervention services in Florida compared to the state with the lowest utilization - Hawaii.</p> <p>There was an annual increase of 277.3% in the utilization of facet joint interventions by general physicians, whereas a 99.5% annual increase was seen for nurse practitioners (NPs) and certified registered nurse anesthetists (CRNAs) from 2002 to 2006. Further, in Florida, 47% of facet joint interventions were performed by general physicians.</p> <p>Conclusions</p> <p>The reported explosive growth of facet joint interventions in managing spinal pain in certain regions and by certain specialties may result in increased regulations and scrutiny with reduced access.</p

Reduction of Surgical Site Infections after Implementation of a Bundle of Care

BACKGROUND: Surgical Site Infections (SSI) are relatively frequent complications after colorectal surgery and are associated with substantial morbidity and mortality. OBJECTIVE: Implementing a bundle of care and measuring the effects on the SSI rate. DESIGN: Prospective quasi experimental cohort study. METHODS: A prospective surveillance for SSI after colorectal surgery was performed in the Amphia Hospital, Breda, from January 1, 2008 until January 1, 2012. As part of a National patient safety initiative, a bundle of care consisting of 4 elements covering the surgical process was introduced in 2009. The elements of the bundle were perioperative antibiotic prophylaxis, hair removal before surgery, perioperative normothermia and discipline in the operating room. Bundle compliance was measured every 3 months in a random sample of surgical procedures. RESULTS: Bundle compliance improved significantly from an average of 10% in 2009 to 60% in 2011. 1537 colorectal procedures were performed during the study period and 300 SSI (19.5%) occurred. SSI were associated with a prolonged length of stay (mean additional length of stay 18 days) and a significantly higher 6 months mortality (Adjusted OR: 2.71, 95% confidence interval 1.76-4.18). Logistic regression showed a significant decrease of the SSI rate that paralleled the introduction of the bundle. The adjusted Odds ratio of the SSI rate was 36% lower in 2011 compared to 2008. CONCLUSION: The implementation of the bundle was associated with improved compliance over time and a 36% reduction of the SSI rate after adjustment for confounders. This makes the bundle an important tool to improve patient safety

Results and Outcome Reporting In ClinicalTrials.gov, What Makes it Happen?

At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials' design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases.We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors' class.As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8%) of them are assigned as FDA regulated and 25151 (21.2%) as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008.The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies

Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American society of interventional pain physicians (ASIPP) guidelines

Background: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use. Objectives: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique. Methods: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ)