By Pat Anson, Editor

A controversial government funded study critical of epidural steroid injections has been republished in the Annals of Internal Medicine, fueling a growing debate over the effectiveness and safety of spinal injections.

A prominent pain specialist called the study’s publication in a peer-reviewed journal “an insult to thousands of physicians across the world."

In a systematic review of 30 placebo controlled trials, researchers found that epidural steroid injections (ESI’s) offer limited or no relief from radiculopathy and spinal stenosis, two conditions that cause low back pain. The study was funded by the Agency for Healthcare Research and Quality (AHRQ) and conducted at the request of the Centers for Medicare and Medicaid Services.

“Epidural corticosteroid injections for radiculopathy were associated with early improvements in some outcomes versus placebo interventions, but effects were small and unsustained, and epidural corticosteroid injections had no clear effects in patients with spinal stenosis,” wrote lead author Roger Chou, MD, a Professor at Oregon Health & Science University (OHSU) School of Medicine and a staff physician in the Internal Medicine Clinic at OHSU.

Epidural injections using analgesics have long been used to relieve pain during childbirth, but spinal injections with steroids are also widely used for back pain. Although the Food and Drug Administration has never approved the use of steroids to treat back pain, several million ESI’s are performed “off label” in the U.S. annually.

The shots have become a common and sometimes lucrative procedure at many hospitals and pain management clinics. Costs vary from a few hundred dollars to over $2,000 per injection.

“Evidence on the effects of using different approaches, corticosteroids, or doses on effectiveness of epidural corticosteroid injections was limited, but indicated no clear effects,” said Chou, who was the principal investigator and author of several other studies published in peer reviewed journals.

“It is a travesty that Chou et al continue to publish these types of manuscripts. It is an insult to thousands of physicians across the world who perform these procedures and millions of patients who have received relief from them,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, conducted several of the studies reviewed by Chou and his colleagues.

“Consumers need to understand that the design of their systematic review is flawed and that significant bias exists in the reporting of the results,” Manchikanti wrote in an email to Pain News Network. “It is like eating 2 bananas from different countries and saying both are equally sweet, so neither is sweet. They also are looking for the differences in improvement between both groups rather than how a patient has improved from before the treatment to after the treatment."

Chou’s study also came under fire when it was released by the AHRQ. The Multisociety Pain Workgroup (MPW), a coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors, sent a lengthy letter to the AHRQ, calling the report's analysis on the effectiveness of ESI's "flawed” and “absurd.”  .

"I don't think its surprising that people who do these injections might disagree or not be happy with the results. Some of the comments seem to demonstrate a poor understanding of how to look at interventions in scientific research," Chou told Pain News Network. "I think people are afraid that they're not going to get paid for doing these types of things. It's not surprising, when people's pocketbooks are threatened, this how they respond."

Chou and his colleagues found the only significant benefit of ESI’s was temporary relief from back pain that usually lasts for only a few days. He attributes much of the pain relief to a placebo effect.

"It's clear that interventions for back pain have a very high placebo effect. We've known that for decades and its been demonstrated over and over again," said Chou.

Manchikanti says most of his patients get pain relief that lasts for several weeks.

“Each patient should be selected individually. They should understand the risks and the off-label nature of these drugs in the epidural space,” he said. “Epidural corticosteroids have been shown to be risky, come with a warning from the FDA, and are an off-label use of these powerful anti-inflammatories.

“For a patient, if they choose to have the procedures done with local anesthetic alone, or with local anesthetic and steroids, they should measure their progress. If they do not improve with the first procedure, they should carefully think about the second procedure; however, there is no reason to have any more than 2 procedures if they do not improve.”

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, also recommends that doctors do not to repeat the injection if a patient shows no sign of improvement.

A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

Terri Anderson says repeated shots gave her temporary pain relief from a bulging disc in her back.

“I did receive immediate and short-term benefits over a 3 year time frame. However, I am here to tell you that the injections did not save me from surgery as the disc ultimately failed,” she said.

Anderson now suffers from arachnoiditis, a chronic and painful inflammation of the spinal column that has left her permanently disabled. The Hamilton, Montana woman believes the condition was brought on by too many injections.

“If I had the opportunity to go back in time, I would have stayed away from intervention and lived with the pain I had which was chronic, but it was manageable,” Anderson said.

“The government and professional medical societies have been keeping chemically induced adhesive arachnoiditis hidden from public awareness. Why is that? There is too much profit at stake for hospitals and pain clinics throughout the country. If a physician were to provide their patients with true informed consent (and explain the horrors of arachnoiditis), then no one in their right mind would undergo an epidural steroid injection.”