Faculty Bibliography

BACKGROUND: The efficacy of epidural and facet joint injections has been assessed utilizing multiple solutions including saline, local anesthetic, steroids, and others. The responses to these various solutions have been variable and have not been systematically assessed with long-term follow-ups. METHODS: Randomized trials utilizing a true active control design were included. The primary outcome measure was pain relief and the secondary outcome measure was functional improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the criteria developed by the American Society of Interventional Pain Physicians (ASIPP) for assessing interventional techniques. An evidence analysis was conducted based on the qualitative level of evidence (Level I to IV). RESULTS: A total of 31 trials met the inclusion criteria. There was Level I evidence that local anesthetic with steroids was effective in managing chronic spinal pain based on multiple high-quality randomized controlled trials. The evidence also showed that local anesthetic with steroids and local anesthetic alone were equally effective except in disc herniation, where the superiority of local anesthetic with steroids was demonstrated over local anesthetic alone. CONCLUSION: This systematic review showed equal efficacy for local anesthetic with steroids and local anesthetic alone in multiple spinal conditions except for disc herniation where the superiority of local anesthetic with steroids was seen over local anesthetic alone.

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.