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10 Articles in Volume 15, Issue #1
Psoriatic Arthritis: Current Strategies for Diagnosis and Treatment
Traumatic Brain Injury: Evaluation, Treatment, and Rehabilitation
Pain Management in the Elderly: Treatment Considerations
9 Best Practices in Evaluating and Treating Pain in Primary Care
Rationale for Medical Management
New York State Enacts New Law to Prevent Drug Diversion
Editor's Memo: Acknowledging the Failure of Standard Pain Treatment
PPM Editorial Board Discusses Epidural Steroid Injections and Blindness
Ask the Expert: False Positive Amphetamine Urine Screens
Letters to the Editor: Pregnenolone, Acute Porphyria, Opioid Calculator, Arachnoiditis

PPM Editorial Board Discusses Epidural Steroid Injections and Blindness

After a reader's brother went blind following a epidural steroid injection, our Editorial Board examines the safety of epidural steroid injections.

Question: When I picked up the September issue of Practical Pain Management,1 I went straight to Dr. Tennant's editorial and it was a good thing that I did! My brother went blind this summer. It was a mystery, at least to his family, until I read the first paragraph of the editorial. I went to my brother and inquired about epidural steroid injections. Sure enough the blindness (hemorrhagic optic neuritis) occurred a few days after he completed a series of lumbar epidural injections.

Why is this horrific carnage allowed to continue, despite Food and Drug Administration warnings and the drugs being unapproved for epidural injections? I trained to perform spine injections at a weekend seminar several years ago but chose not pursue this practice because no clear evidence of efficacy was presented.

My brother is an artist with a caulking gun and keeps 25 to 30 men and women employed performing this craft. He has a beautiful wife, a daughter, and a host of beautiful granddaughters who he will never be able to see again. He is not just a statistic. We were saddened to learn of the tragedy that occurred within your family after an epidural steroid injection. This and other such outcomes have raised concerns about the safety of epidural steroid injections. Indeed, there have been reports in the literature of rare but serious complications after epidural steroid injections including stroke, blindness, paralysis, and death. (see Editor's Note).

Editor's Note: In April 2014, the Food and Drug Administration ordered a label warning for epidural injections to include the risks of severe adverse events (death, stroke, permanent blindness, and paralysis). While these events are considered rare, the agency noted that the severity of potential outcomes warranted a written caution.2

In October 2014, the FDA’s department of pharmacovigilance published a review of injectable steroids. A summary of its findings found 131 cases of serious adverse neurological events including 41 cases of arachnoiditis. Particulate steroids have more adverse events, but the agency noted at that time: “it is not know whether this difference reflects greater utilization of particulate steroid or greater toxicity.”3

In November 2014, after convening a two-day meeting to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections, the Anesthesia and Analgesic Drug Products Advisory Committee voted 15-7 in favor of calling particulate steroids “contraindicated for transforminal cervical injections” because they appear to carry greater risk of adverse neurological effects than nonparticulate agents. As of press time, the FDA has not made a final ruling.

Consider the Benefits of ESI

Eric Brimhall, MD, and Richard Rosenthal, MD (pictured left)
Provo, Utah

As pain medicine physicians, we have a vested interest in making sure that all the procedures we offer to our patients are safe and effective enough to justify the risks. As with all treatments, there are both risks and benefits to epidural steroids. However, we believe the debate about epidural steroids has thus far been focused on the risks of the treatment without accurate or adequate consideration of the benefits.

To begin, the question of efficacy of epidural steroids is of vital importance, as the performance of any procedure in the absence of efficacy would certainly be irresponsible. There are a number of high quality studies showing epidural steroid injections do indeed benefit patients.

Studies Supporting Efficacy

Ghahreman et al carried out a prospective, double-blind, randomized control trial comparing the efficacy of transforaminal epidural steroid injection with a variety of control treatments including transforaminal injection of local anesthetic alone, transforaminal saline, intramuscular injection of steroid and intramuscular saline for the treatment of lumbar radicular pain.4 The primary outcome measure in this study was the proportion of patients who achieved at least 50% pain relief at 1 month and secondary outcomes included measurements of function and disability. The study found a statistically significant difference between the epidural steroid group and any other group—54% of the epidural steroid patients achieved the desired relief (95% CI +/- 18%) while patients receiving any of the other treatments were statistically indistinguishable from each other with an average of only 15% achieving the desired relief (95% CI +/- 7%). In addition, the proportion of those receiving relief from epidural steroids remained significantly higher than the other groups at 12 month follow up. Secondary outcomes were also favorable in the epidural steroid group.4

In a prospective, randomized, controlled, double-blind trial, Riew et al demonstrated a highly significant difference in surgical rates for patients suffering from radicular pain who were treated with transforaminal epidural steroid and local anesthetic versus those treated with local anesthetic alone.5 During the 13 to 28 month post-procedure follow up period, only 29% of the patients treated with steroid and anesthetic underwent surgery while 66% of those treated with anesthetic alone required surgery.5

In a prospective, randomized control trial, Vad et al compared a transforaminal epidural steroid injection to a deep paraspinal trigger point injection with saline. Measurement outcomes included an improvement in the Roland-Morris back pain score, improvement in a visual numeric pain scale, improvement in a measure of hip flexion tolerance and a positive patient satisfaction score. At an average follow up of 16 months, the patients receiving the ESI had an 84% success rate compared to 48% in those receiving the saline injection.6 With this as a background, systematic reviews and meta-analysis summarizing the research done on this topic7,8 have found that up to 70% of patients receive 50% pain relief for 1-2 months while 30% receive complete pain relief.8 For those with disc herniation, up to 70% receive 50% relief for 6 months.9

From the preponderance of the evidence, it seems reasonable to conclude that, when preformed on patients with appropriate indications, epidural steroid injections have demonstrated efficacy in reducing pain, improving function, and lessening the need for more invasive treatments such as surgery.

Safety Risk of ESI

With a robust amount of literature supporting the efficacy of epidural steroids, we must also consider the safety of these procedures, for even in procedures with demonstrated efficacy, safety must be of the highest concern. This begs the question, what are the safety risks of epidural steroid injections and how are they addressed?

Beginning in approximately the early 2000’s, case reports started appearing in the literature noting serious complications following an injection of particulate steroid into the epidural space, with adverse outcomes including paralysis, stroke, blindness and even death.10-17 These events are thought to result from inadvertent injection of large or medium particle steroid preparations into the radicular or vertebral arteries that provide blood supply to the brain, spinal cord, and cranial nerves. The mechanism of injury is thought to be due to embolization of clumps or aggregates of steroid particles occluding arterioles or capillaries supplying vital blood flow to these vulnerable structures.

Studies investigating the steroids commonly used in epidural procedures revealed that there is significant variability in particle size from one steroid preparation to another and some steroid preparations also have the propensity to aggregate in solution. Derby et al showed that steroid preparations with large and medium sized particles tended to form aggregates that were larger than the size of red blood cells and it is these preparations that are implicated in the reported cases of central nervous system injury.18

On the other hand, the particles contained in dexamethasone have been shown to be 5 to 10 times smaller than red blood cells and did not form aggregates. Initially there was some hesitation about the use of dexamethasone as there was not as much literature demonstrating efficacy but recent studies by Kennedy, El-Yahchouchi, and others have found that clinical outcomes when using dexamethasone are comparable to the steroid preparations with larger particle size.9,19 Of particular importance is the fact that there have been no reports of serious neurologic adverse events with use of dexamethasone.

Expert Guidelines

As a result of these findings, a group composed of several medical specialty societies representing physicians who perform epidural steroid injections and who are known as the Multi-Society Pain Workgroup (MPW) developed a set of consensus recommendations for the safe administration of epidural steroid injections that make dexamethasone the standard of care for these procedures.20 We believe that with proper adherence to these guidelines, the tragic complications such as those discussed here can be avoided. A fact finder with further information on the topic of particulate and non-particulate steroids can be found at https://www.spinalinjection.org/fact-finder.php?pID=6.21

Another aspect of safety to be considered when discussing epidural steroids is that of infections caused by improper operator technique. This issue was voiced by Dr. Tennant in a recent editorial in which he rightly points out that epidural steroid injections require attention to detail to reduce infectious risk.1 This point and several others were specifically addressed by the MPW in their consensus recommendations.18 We agree with Dr. Tennant and the guidelines that meticulous care in sterile technique is essential.

Need for Epidural Steroid Injections

Finally, let us imagine a world without epidural steroid injections—what would that look like? A patient who presented with a herniated intervertebral disc and resulting radicular pain would have only a handful of treatment options. Medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-epileptics, and opioids could be tried in the short term, but long term management with these medications is not ideal and carries significant risk of their own.22,23 Surgery is, of course, an option but is not 100% successful and can result in spinal instability requiring the need for further surgery in the future. Spinal cord stimulation has been shown to be effective for some patients but we feel that such a measure is costly and unwarranted when a simpler option for treatment exists. Fortunately, the natural course of such symptoms is favorable and, given time, they may resolve without treatment. However, it may take a year or more for the symptoms to resolve during which time the patient is subjected to severe unremitting neuropathic pain that can interfere with sleep, cause several mood disorders, limit function, mobility, and the ability to work and which is associated with other health complications including weight gain, hypertension, and coronary artery disease among others.

The treatment of chronic pain is a serious matter for physician and patient alike and as physicians we seek to find treatments that are both safe and effective for our patients. We feel that by following recommended guidelines, epidural steroids offer an effective, safe, and vital treatment option for properly selected patients.

Consider Other Causes Of Blindness

Elmer G. Pinzon, MD
Knoxville, Tennessee

I am also sorry for this unfortunate occurrence and feel for this individual and his family. It should be noted, however, that there are multiple other causes of hemorrhagic optic neuritis (hypertension, multiple sclerosis, infectious diseases, tumors, chemical/drug exposures, other metabolic diseases, etc), which should be evaluated by a team of trained medical professionals.

As a board-certified and fellowship-trained physician who has performed thousands of various spinal injections and other pain relieving musculoskeletal procedures since 1998, I have found that the literature and empirical medical practice is in support of the beneficial use of spinal injections and other pain-relieving procedures performed in the pain medicine community.

As with all medical procedures, there are a small minority of potential complications and side effects—the majority of spinal medical procedures have positive and beneficial outcomes for this sector of the medical community. I would recommend that this individual look to other potential causes of hemorrhagic optic neuritis in his brother, but to be aware that this is a rare, infrequent, albeit unfortunate complication in this spinal procedure.

I wish this individual well in his recovery and rehabilitation during his healing phase.

Last updated on: April 13, 2015

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