Faculty Bibliography

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.

Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians' individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The design of the trial was inappropriate with failure to include existing randomized trials, with inclusion criteria that did not incorporate conservative management,or caudal epidural injections. Simultaneously, acute pain patients were included, multilevel stenosis and various other factors were not identified. The interventions included lumbar interlaminar and transforaminal epidural injections with highly variable volumes of medication being injected per patient. Outcomes assessment was not optimal with assessment of the patients at 3 and 6 weeks for a procedure which provides on average 3 weeks of relief and utilizing an instrument which is more appropriately utilized in acute and subacute low back pain. Analysis of the data was hampered by inadequate subgroup analysis leading to inappropriate interpretation. Based on the available data epidural local anesthetic with steroids was clearly superior at 3 weeks and potentially at 6 weeks. Further, both treatments were effective considering the baseline to 3 week and 6 week assessment, appropriate subgroup analysis seems to have yielded significant superiority for interlaminar epidural injections compared to transforaminal epidural injections with local anesthetic with or without steroids specifically with proportion of patients achieving greater than 50% improvement at 3 and 6 week levels. This critical assessment shows that this study suffers from a challenging design, was premised on the exclusion of available high-quality literature, and had inadequate duration of follow-up for an interventional technique with poor assessment criteria and reporting. Finally the analysis and interpretation of data has led to inaccurate and inappropriate conclusions which we do not believe is based on scientific evidence.

BACKGROUND: Interlaminar epidural steroid injection is a well-established intervention for the treatment of radicular pain. Pain is commonly reported during the injection into the epidural space; this provocation is typically either concordant or discordant with the patient's baseline pain. It is not well known how this provocation pain relates to treatment outcomes. OBJECTIVE: To determine the relationship between concordant versus discordant provocation during interlaminar epidural steroid injection and its effects on pain reduction at follow-up. STUDY DESIGN: Secondary analysis of a single center, prospective randomized double-blind study. METHODS: Interlaminar epidural steroid injections under fluoroscopic guidance were performed on 48 patients with radicular lumbosacral pain. After injection with 80 mg methylprednisolone and 2 mL of normal saline at a single level, patients were asked to report if pain was provoked, and whether the pain was concordant or discordant with their baseline pain. The primary outcome measure was self-rated percentage of pain reduction from baseline at 2-week follow-up. Secondary outcomes included improvement in activity level and decreased analgesic consumption. RESULTS: Provocation was observed in 37 out of 48 patients (77%). This was further classified as concordant (22/37, 60%) or discordant (15/37, 40%) pain. The concordant group achieved a significant decrease in self-reported pain as compared to the discordant group at 2-week follow-up (61%, t = 2.45, P < 0.01). There were also significantly more patients in the concordant group who reported 75% pain reduction as compared to the discordant group (X = 6.44, df(1), P < 0.05). There were no significant differences between concordant and discordant groups in regard to improvements in activity level (X = 2.56) and decreased analgesic use (X = 3.28). LIMITATIONS: The secondary analysis did not examine long-term outcomes. CONCLUSIONS: The concordant group demonstrated significantly higher pain reduction as compared to the discordant group. There were no significant differences between the 2 groups in terms of improved function or reduced analgesic requirements. Concordant provocation during interlaminar epidural injection may be a predictor of outcome.

OBJECTIVE: A performance improvement continuing medical education (PI CME) activity was designed to assist clinicians with accurately identifying and appropriately managing persistent pain in long-term care facility (LTCF) residents. DESIGN: Volunteer LTCFs participated in a three-stage PI CME model consisting of: 1) baseline assessment, 2) implementation of practice improvement interventions, and 3) reassessment. Expert faculty chose performance measures and interventions for the activity. A champion was designated ateach LTCF to collect resident charts and enter data into an online database. SETTING: Eight LTCFs located across the United States participated in the activity. PATIENTS: Fifty resident charts were randomly selected by each LTCF champion (25 for stage 1 and 25 for stage 3); a total of 350 charts were reviewed. INTERVENTIONS: In addition to a toolkit containing numerous performance improvement resources, an in-service meeting led by an expert faculty member was conducted at each LTCF. OUTCOME MEASURES: Stage 3 data were collected 6 weeks after implementation of interventions and compared with stage 1 baseline data to measure change in performance. RESULTS: Aggregate data collected from seven LTCFs completing the PI CME activity through stage 3 revealed improvements from baseline in four of five performance measures. CONCLUSIONS: This CME activity allowed for collection of data demonstrating performance improvement in persistent pain management. The tools used as part of the intervention (available at http://www.achlpicme.org/LTC/toolkit) may help other clinicians enhance their management of LTCF residents with persistent pain.

OBJECTIVE: The concept of neuromodulation via the use of spinal cord stimulators (SCS) was first established over forty years ago. Since then, its popularity has grown as numerous studies have demonstrated its utility to reduce chronic pain, improve patient function, and reduce long-term health care costs. The aim of this study was to update the pain medicine community on the evolution of SCS practice trends in academic centers. DESIGN: Ninety-three pain medicine fellowship programs in the United States were identified from the Accreditation Council for Graduate Medical Education Website and were contacted to participate in an internet survey. A 37-item questionnaire was inspired by a previous study performed by Fanciullo et al. Questions focused on three main themes regarding SCS clinical application, namely demographics, education, and technical matters. RESULTS: Completed surveys were received from 50 institutions, all of which reported performing SCS interventions. Annual implants ranged from 0 to 150. Fellowship training was cited as the most valuable modality for learning implantation. Nearly all programs reported manufacturer representative participation during SCS procedures, with a minority of program directors discouraging their involvement in fellow education. SCS trials were performed exclusively on an outpatient basis. The average length for trials was 4-7 days. The most common indication for SCS implantation was failed back surgery syndrome, which also had the highest 2-year success rate. Post procedure, patients generally were followed up every 2-4 weeks for device reprogramming, which was performed by company representatives 92% of the time. CONCLUSION: Standardized SCS training is imperative as the implementation of neuromodulation therapy continues to increase.

Background: Topical analgesics are important products in the armamentarium for pain relief. Methods and Findings: This study compared a topical analgesic product containing menthol to the same product with the addition of oxygenated glycerol triesters (OGTs) (also called essential oxygen oil) in 66 healthy adult subjects with acute musculoskeletal pain. Patients were randomized in a single-center, double-blind study to receive mentholated cream (MC) only or MC containing OGTs. Patients self-reported their pain intensity, lifestyle limitations, and evaluation of the mobility of the painful joint or muscle at baseline and three times daily over a seven-day course on a 100-mm visual analog scale (VAS). Patients in both groups experienced statistically significant pain relief on Day 8 over baseline, with the MC plus OGT-treated group reporting statistically significantly greater pain relief than the MC group (P = 0.016). In addition, patients treated with the combination product experienced an incremental decrease in pain during each of the 7 days of treatment in addition, and they had lower VAS scores and greater lifestyle and mobility improvements than the MC group. Both products were well tolerated with no serious adverse events reported and no signs of significant skin reactions in either group. Conclusion: Based on this study, a MC containing OGTs is safe, effective, and provided significantly better pain relief than MC alone. The combination of oxygenated glycerol trimesters and MC provided significant pain relief and offered continued improvement in pain relief over time.