Steroid Epidural Injections No Benefit in Spinal Stenosis

July 03, 2014

In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit compared with epidural injection of lidocaine alone, a new randomized controlled study shows.

"People have generally believed that it is the steroid that is the active component of the steroid/lidocaine combination, but our results suggest that this does not appear to be the case. We didn't see any particularly serious clinical adverse effects, but the steroid group did show significant cortisol suppression, so there is some risk. And this, along with very little evidence of any benefit, would lead me to say that in my mind, the risks outweigh the benefits," lead researcher Janna L. Friedly, MD, from the Department of Rehabilitation Medicine, University of Washington, Seattle, told Medscape Medical News.

"So our study suggests we are giving people a lot of unnecessary epidural injections and spending a lot of money without clear benefits. My recommendation is that patients with spinal stenosis should be treated with epidural lidocaine alone or alternative treatments," she added.

The study was published in the July 3 issue of the New England Journal of Medicine.

300% Increase in Use

In their article, the researchers note that lumbar spinal stenosis is a common cause of spine-related disability in older adults and that a popular treatment for the condition is epidural injection of glucocorticoid/anaesthetic combinations.

They report that an estimated 25% of all epidural glucocorticoid injections administered in the US Medicare population (aged 65 years or older) are for spinal stenosis. Rates and associated costs of these injections for spinal stenosis increased nearly 300% over the course of the last 2 decades, they note, "and it is estimated that more than 2.2 million lumbar epidural glucocorticoid injections are performed each year in the Medicare population."

The steroids are thought to relieve pain by reducing nerve root inflammation and ischemia, but data are lacking from rigorous randomized controlled trials. Therefore, Dr. Friedly and colleagues designed the current study, known as the Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) trial.

For the study, 400 patients with lumbar central spinal stenosis and moderate-to-severe leg pain and disability were randomly assigned to receive 1 or 2 epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The primary outcomes — disability score on the Roland–Morris Disability Questionnaire and intensity of leg pain (on a scale from 0 - 10) at 6 weeks — showed no significant difference between the 2 groups.

Table. Mean Change From Baseline at 6 Weeks in Disability and Pain Scores

Score Lidocaine Glucocorticoid–Lidocaine Adjusted Difference P Value
Roland–Morris Disability Questionnaire disability score −3.1 −4.2 −1.0 .07
Pain score −2.6 −2.8 −0.2 .48

A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs transforaminal) also showed no significant differences at 6 weeks. However, the interlaminar method was associated with fewer adverse effects, regardless of whether the injection contained lidocaine alone or in combination with steroids.

"This is the largest multicenter study of epidural steroids for spinal stenosis. Addition of the steroid to the anesthetic showed no benefit. Both groups improved to some degree, but the steroid doesn't seem to add anything on top of the lidocaine, We didn't have a placebo group, so we can't tell if the lidocaine injection is doing anything. Lidocaine has a very short half-life, so it is unclear how it could be causing benefit for up to 6 weeks," said Dr. Friedly.

She added that the next logical step would be to conduct a trial comparing lidocaine with placebo but said this would be difficult to do, as patients in pain do not generally like the idea that they might be given a placebo.

FDA Warning

In an accompanying editorial, Gunnar B.J. Andersson, MD, from Rush University Medical Center, Chicago, Illinois, points out that epidural steroid injections are generally considered to be safe, with minor transient adverse effects, but the US Food and Drug Administration (FDA) has recently warned of the possibility of serious or even catastrophic complications, including paralysis, nerve damage, or death.

"Certainly, this study raises serious questions about the benefits of epidural glucocorticoid injections for spinal stenosis. In patients who nonetheless proceed with an epidural glucocorticoid injection, repeat injections should be avoided if there is no effect," he writes.

Noting that at present, many insurance companies require epidural injections as part of nonsurgical treatment before surgery is approved, Dr. Andersson notes, "[t]he current trial and the FDA safety announcement suggest that this requirement should be reconsidered."

In his editorial, Dr. Andersson also notes that the glucocorticoids appeared to confer a small benefit compared with lidocaine alone in the first 3 weeks, but that the longer-term benefits anticipated with glucocorticoids did not occur. He also points out that more patients in the glucocorticoid–lidocaine group reported they were satisfied with their treatment, which he suggests may be because of a systemic effect of the steroids.

This study was supported by a grant from the Agency for Healthcare Research and Quality. One coauthor reports holding stock in and being a former employee of Johnson & Johnson, another coauthor reports receiving consulting fees from ArthroCare and grant support through his institution from Cytonics and Seikagaku, and another coauthor reports receiving fees for serving on an advisory board for General Electric and consulting fees from HealthHelp and holding patents (issued to PhysioSonics) regarding acoustic palpation with the use of noninvasive ultrasonographic techniques for identification of target sites and assessment of chronic pain disorders. The other authors and Dr. Andersson have disclosed no relevant financial relationships.

N Engl J Med. 2014;371:11-21. Abstract, Editorial extract

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