Epidural steroid injections: FDA provides safety warning

Last month, the United States Food & Drug Administration (FDA) issued a warning on the safety of epidural steroid injections for back and neck pain. Epidural steroid injections, they said, “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.” They advised providers who perform epidural steroid injections and their patients to discuss these risks prior to making the decision to undergo the procedure.

When used for back or neck pain, epidural steroid injections deliver steroid into the epidural space of the spine. The steroid has anti-inflammatory properties. The goal is to reduce inflammation around the nerves of the spine and thereby produce a temporary reduction in pain.

The FDA states that this warning is unrelated to the issue in 2012 when a number of patients became ill and even died because they had been injected with steroid that had been contaminated in the manufacturing process.

Timely nature of the FDA warning

This warning is important because epidural steroid injections are an increasingly common procedure for chronic back or neck pain. Their widespread use has occurred over the last twenty to twenty-five years. From 1994-2001, their use increased by 271% in the US (Friedly, Chan, & Deyo, 2007). From 2000-2008, their use increased another 186% (Manchikanti, L., et al., 2013).

Epidural steroid injections are not FDA-approved for back or neck pain

This widespread use of epidural steroid injections is controversial. Research shows that on average epidural steroid injections are ineffective for chronic back and neck pain (see, e.g., Bickett, et al., 2013, Staal, et al., 2008) or for radicular pain, such as sciatica (Iverson, 2011). At best, in some clinical trials, epidural steroid injections have been shown to provide statistically significant improvements in the leg pain of sciatica, but the improvements are so small that from the real world perspective of a patient the improvements are irrelevant (Carette, et al., 1997; Quraishi, 2012). No published studies show that epidural steroid injections reduce disability related to back or neck pain.

Proponents of the procedure often argue that that the use of epidural steroid injections can reduce the need for spine surgery. However, empirical research does not support this argument (Carette, et al., 1997).

Due to the lack of evidence for the effectiveness of epidural steroid injections, a number of pain experts question their widespread use (Deyo, 2009; Schofferman, 2006; Taylor, 2011).

The FDA, in their warning, explicitly emphasizes this lack of evidence for the effectiveness of epidural steroid injections. They state that the use of epidural steroid injections for the treatment of back or neck pain is not an FDA-approved procedure because the procedure has not been shown to be effective.

References

Bickett, M. C., Gupta, A., Brown, C. H., & Cohen, S. P. (2013). Epidural injections for spinal pain: A systematic review and meta-analysis evaluating the “control” injections in randomized controlled trials. Anesthesiology, 119(4), 907-931. doi: 10.1097/ALN.0b013e31829c2ddd

Carette, S., Leclaire, R., Marcoux, S., Morin, F., Blaise, G. A., St. Pierre, A., Truchon, R., Parent, F., Levesque, J., Bergeron, V., Montminy, P., & Blanchette, C. (1997). Epidural corticosteroid injections for sciatica for herniated nucleus pulposus. New England Journal of Medicine, 336, 1634-1640. doi: 10.1056/NEJM199706053362303

Deyo, R. A., Mirza, S. K., Turner, J. A., & Martin, B. I. (2009). Overtreating back pain: Time to back off? Journal of the American Board of Family Medicine, 22(1), 62-68. doi: 10.3122/jabfm.2009.01.080102

Friedly, J., Chan, L., & Deyo, R. (2007). Increases in lumbosacral injections in the Medicare population: 1994-2001. Spine, 32, 1754-1760.

Iverson, T., Solberg, T. K., Romner, B., Wilsgaard, T., Twisk, J., Anke, A., Nygaard, O., Hasvold, T., & Ingebrigtsen, T. (2011). Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: Multicentre, blinded, randomized controlled trial. BMJ, 343, d5278. doi: 10.1136/bmj.d5278

Manchikanti, Pampati, V., Falco, F., & Hirsch, J. A. (2013). Growth of spinal interventional pain management techniques: Analysis of utilization trends and Medicare expenditures 2000 to 2008. Spine, 38(2), 157-168. doi: 1097/BRS.0b013e318267f463

Quraishi, N. A. (2012). Transforaminal injection of corticosteroids for lumbar radiculopathy: Systematic review and meta-analysis. European Spine Journal, 21(2), 214-219. doi: 10.1007/s00586-011-2008-y

Schofferman, J. (2006). Interventional pain medicine: Financial success and ethical practice: An oxymoron? Pain Medicine, 7, 5, 457-460.

Staal, J. B., de Bie, R., de Vet, H. C., Hildebrandt, J., & Nelemans, P. (2008). Injection therapy for subacute and chronic low-back pain. Cochrane Database of Systematic Reviews, 3(3). doi: 10.1002/14651858.CD001824.pub3

Taylor, M. L. (2011). The impact of the “business” of pain medicine on patient care. Pain Medicine, 12, 5, 763-772.

AUTHOR: Murray J. McAllister, PsyD

DATE OF LAST MODIFICATION: 5-4-2014

Is Spinal Surgery for Neck Pain Effective?

The third of three reviews of research on spinal surgery for neck pain was recently published by a group of well-known pain experts (van Middelkoop, et al., 2012; van Middelkoop, et al., 2013; Verhagen, et al., 2013). The investigators indicated that they undertook the reviews of research on different aspects of neck surgery because the most recent previous studies, done as Cochrane reviews (Fouyas, et al., 2002; Nikolaidis, et al., 2008), were now a bit outdated. So, they systematically reviewed the latest published research on different types of spinal surgery for neck pain to determine whether and how such surgeries are effective. What they found was that spinal surgery for neck pain is not any more effective than other, less invasive, therapies. Moreover, they found that the published clinical trials on surgeries for neck pain commonly suffered from poor quality research methods and/or a high risk of bias that might skew the results towards surgery. These latest reviews echo the earlier Cochrane reviews of the research. The Cochrane reviews also found that spinal surgery for neck pain is no more effective than other therapies.

Taken altogether, we now have about two decades of scientific research showing that spinal surgery for neck pain adds no value over less invasive therapies.

Specifically, here’s what they found:

  • Regardless of type of surgery or technique, spinal surgery for neck pain is no more effective than less invasive, non-surgical therapies for neck pain (Middelkoop, et al., 2012).
  • Fusion surgery is not more effective than other spinal surgeries that do not involve fusion (Middelkoop, et al., 2013).
  • Fusion with artificial discs provides no clinically significant benefit over other types of fusion surgery (Verhagen, et al., 2013).
  • There is no one type of spinal surgery for neck pain that is especially better than any other type (Verhagen, et al., 2013).

These findings are important because spinal surgery for neck pain is by no means a benign treatment. Such surgeries are apt to have higher and more significant rates of complications, relative to less invasive treatments of at least equal therapeutic value. They are also significantly more expensive. As such, these findings might give providers and patients pause before pursuing spinal surgeries for neck pain.

Interestingly, however, the accumulation of this research over the years has not provided any pause to the exponential increases in the rates of spinal surgeries for neck pain (Davis, 1994; Marawar, et al., 2010).

References

Davis, H. (1994). Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine, 19(10), 1117-1123.

Fouyas, I. P., Statham, P. F., & Sandercock, P. A. (2002). Cochrane review on the role of surgery in cervical spondylotic radiculomyopathy. Spine, 27(7), 736-747.

Marawar, S., Girardi, F. P., Sama, A. A., Ma, Y. Gaber-Baylis, L. K., Basculides, S. C., & Memtsoudis, S. G. (2010). National trends in anterior cervical fusion procedures. Spine, 35(15), 1454-1459. doi: 10.1097/BRS.0b01381bef3cb

van Middelkoop, M., Rubinstein, S. M., Ostelo, R., van Tulder, M. W., Peul, W., Koes, B. W., & Verhagen, A. P. (2012). Surgery versus conservative care for neck pain: A systematic review. European Spine Journal, 22(1), 87-95. doi: 10.1007/s00586-012-2553-z

van Middelkoop, M., Rubinstein, S. M., Ostelo, R., van Tulder, M. W., Peul, W., Koes, B. W., & Verhagen, A. P. (2013). No additional value of fusion techniques on anterior discectomy for neck pain: A systematic review. Pain, 153, 2167-2173.

Nikolaidis I., Fouyas, I. P., Sandercock, P. A., & Statham, P. F. (Updated December 14, 2008). Surgery for cervical radiculopathy or myelopathy. [Cochrane Review]. In Cochrane Database of Systematic Reviews, 2010 (1).

Verhagen, A. P., van Middelkoop, M, Rubinstein, S. M., Ostelo, R., Jacobs, W., Peul, W., Koes, B. W. van Tulder, M. W. (2013). Effect of various kinds of cervical spinal surgery on clinical outcomes: A systematic review and meta-analysis. Pain, 154, 2388-2396.

Author: Murray J. McAllister, PsyD

Date of Last Modification: 12-8-2013