No abstract

Background: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. Study Design: A randomized, controlled, double blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objectives: To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. Methods: One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. Outcome Assessment: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. Results: In the successful category, 77% of Group I had significant pain relief of ≥ 50% and functional status improvement of ≥ 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Limitations: Presumed limitations of this evaluation include lack of a placebo group. Conclusion: Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. Key words: Chronic low back pain, caudal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning 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.” The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA’s Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence. Key words: Chronic pain, epidural injections, epidural steroids, local anesthetic, radicular artery, complication.

In 148 patients with focal cerebral lesions the findings of EEG mapping, routine EEG and CT were compared. Regarding etiology 43 patients suffered from completed stroke (CS), 43 patients from transient ischemic attack (TIA), 33 patients had an intracerebral hemorrhage (ICH) and 29 an hemispheric tumor. In 37 patients with CS (86%) and 27 patients with TIA (63%) the EEG mapping revealed focal changes, but only in 28 patients with CS (65%) and in 11 patients (26%) with TIA using routine EEG alone. Thus the EEG mapping showed focal abnormalities significantly more often. In the remaining patient groups no significant difference in the results of EEG mapping or routine EEG could be demonstrated. Focal abnormalities corresponding to focal lesions seen in CT were obtained by means of EEG mapping in 27 patients (90%) with CS and 10 patients (77%) with TIA, but only in 17 patients (57%) with CS and 4 patients (31%) with TIA using routine EEG and in that way the EEG mapping could indicate focal lesions in CT significantly more often than routine EEG. In the remaining patient groups no significant difference in the number of focal changes corresponding to lesions in CT could be seen.

The forced implementation of ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) codes that are specific to the United States, scheduled for implementation October 1, 2015, which is vastly different from ICD-10 (International Classification of Diseases, Tenth Revision), implemented worldwide, which has 14,400 codes, compared to ICD-10-CM with 144,000 codes to be implemented in the United States is a major concern to practicing U.S. physicians and a bonanza for health IT and hospital industry. This implementation is based on a liberal interpretation of the Health Insurance Portability and Accountability Act (HIPAA), which requires an update to ICD-9- CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and says nothing about ICD-10 or beyond. On June 29, 2015, the Supreme Court ruled that the Environmental Protection Agency unreasonably interpreted the Clean Air Act when it decided to set limits on the emissions of toxic pollutants from power plants, without first considering the costs on the industry. Thus, to do so is applicable to the medical industry with the Centers for Medicare and Medicaid Services (CMS) unreasonably interpreting HIPAA and imposing existent extensive regulations without considering the cost. In the United States, ICD-10-CM with a 10-fold increase in the number of codes has resulted in a system which has become so complicated that it no longer compares with any other country. Moreover, most WHO members use the ICD-10 system (not ICD-10-CM) only to record mortality in 138 countries or morbidity in 99 countries. Currently, only 10 countries employ ICD-10 (not ICD-10-CM) in the reimbursement process, 6 of which have a single payer health care system. Development of ICD-10-CM is managed by 4 non-physician groups, known as cooperating parties. They include the Centers for Disease Control and Prevention (CDC), CMS, the American Hospital Association (AHA), and the American Health Information Management Association (AHIMA). The AHIMA has taken the lead with the AHA just behind, both with escalating profits and influence, essentially creating a statutory monopoly for their own benefit. Further, the ICD-10-CM coalition includes 3M which will boost its revenues and profits substantially with its implementation and Blue Cross Blue Shield which has its own agenda. Physician groups are not a party to these cooperating parties or coalitions, having only a peripheral involvement. ICD-10-CM creates numerous deficiencies with 500 codes that are more specific in ICD-9-CM than ICD-10-CM. The costs of an implementation are enormous, along with maintenance costs, productivity, and cash disruptions. Key words: ICD-10-CM, ICD-10, ICD-9-CM (International Classification of Diseases, 10th Revision, Ninth revision, Clinical Modification), Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology (HIT), costs of implementation