POINT:
ESIs are of value in treating LSS

Seyed Babak “Bobby” Kalantar, MD

Nonsurgical vs. surgical treatment of lumbar spinal stenosis (LSS) has been compared in the randomized and observational Spine Patient Outcomes Research Trial (SPORT), which demonstrated a statistically signficant advantage to surgery over nonsurgical management in the as-treated analysis. Nonsurgical treatment, however, did also result in a modest improvement in outcome measures. An increasingly common nonsurgical treatment method is the epidural steroid injection (ESI).

In assessing whether ESIs are valuable in the treatment of patients with LSS, the following questions need to be asked:

1. Is nonsurgical treatment safe?
2. Is delaying surgery by performing or referring for injections problematic?
3. Do ESIs work?

Studies have examined the safety of nonsurgical treatment for LSS. In one study, untreated LSS patients were followed for 49 months. Symptoms of stenosis remained unchanged in 70 percent of patients, improved in 15 percent, and worsened in 15 percent. None of the patients had severe neurologic deterioration.

The SPORT trial also demonstrated the safety of nonsurgical treatment, showing no cases of paralysis and similar 4-year mortality rates in both the surgical and nonsurgical groups.

A recent subgroup analysis of the SPORT trial concluded that patients with symptoms of spinal stenosis for less than 12 months did significantly better than those who had symptoms for 12 months or more, regardless of surgical or nonsurgical treatment. The authors acknowledged that the analysis had inherent limitations, including the potential that confounding variables were not equally distributed between the treatment groups and the fact that the original study was designed and powered to address a different hypothesis.

Other studies, including several meta-analyses, have not been able to conclude that duration of symptoms has an effect on outcome. If future studies confirm this conclusion, surgeons should appropriately counsel their patients on this apparent “watershed” moment. Based on current studies, however, using ESI during the first year of symptoms is entirely appropriate.

Do ESIs work? Many clinicians cite poor results in older literature reporting on injections performed without fluoroscopic guidance. More recent studies evaluating fluoroscopically guided epidural injections demonstrate that injections can provide temporary relief, especially in patients with radicular symptoms. A prospective study of patients with radicular pain caused by degenerative LSS found that, after transforaminal injections, 75 percent of patients noted at least a 50 percent reduction in pain scores, 64 percent had improved walking tolerance, and 57 percent had improved standing tolerance at 1-year follow-up.

Multiple retrospective studies also support this finding. One group has established a protocol for a double-blind, randomized, controlled multicenter study to assess the efficacy of ESI in LSS. It is hoped that this will more clearly define the role of injections.

Patients may have strong aversions or contraindication to surgery. Surgery requires the patient to commit to the potential risks, complications, and, in some cases, prolonged recovery that may occur with a lumbar spinal operation. It is not unexpected that a patient would try to avoid surgery.

As long as nonsurgical treatment will not endanger the patient, an ESI can help alleviate symptoms and, if ineffective or short-lived, allow the patient to more comfortably arrive at the conclusion that surgery may be the only effective treatment left. Considering current information, ESIs are a valuable tool in the treatment of patients with LSS.

Seyed Babak “Bobby” Kalantar, MD, is an assistant professor in spinal surgery at the Georgetown Department of Orthopedics. He can be reached at bkalantar@gmail.com

Disclosure information: Dr. Kalantar—Nuvasive

References

1. Weinstein JN, Tosteson TD, Lurie JD, et al: Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine (Phila Pa 1976) 2010;35(14):1329-1338
2. Johnsson KE, Rosén I, Udén A: The natural course of lumbar spinal stenosis. Clin Orthop Relat Res 1992;(279):82-86.
3. Radcliff KE, Rihn J, Hilibrand A, et al: Does the duration of symptoms in patients with spinal stenosis and degenerative spondylolisthesis affect outcomes? Analysis of the Spine Outcomes Research Trial. Spine (Phila Pa 1976) 2011;36(25):2197-2210.
4. Botwin K, Brown LA, Fishman M, Rao S: Fluoroscopically guided caudal epidural steroid injections in degenerative lumbar spine stenosis. Pain Physician. 2007;10(4):547-558.
5. Friedly JL, Bresnahan BW, Comstock B, et al: Study protocol: Lumbar Epidural steroid injections for Spinal Stenosis (LESS): A double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord 2012;13:48.

Counterpoint:
ESIs have no role in treating LSS

Kristen E. Radcliff, MD

Epidural steroid injections (ESIs) are a common treatment of lumbar radiculopathy. They have been established to improve the outcome of nonsurgical treatment and contribute to surgical avoidance in patients with lumbar disk herniation. ESIs are commonly used to treat lumbar stenosis although limited biologic, clinical, or empiric evidence supports their use in this population. In this debate, I argue that ESIs have no role in treating patients with lumbar stenosis.

The use of ESI in patients with lumbar stenosis has a limited biologic rationale. Lumbar stenosis occurs in a unique patient population, likely due to vascular and compressive factors, not inflammatory factors. Injection agents can have deleterious effects on periarticular tissues and exacerbate the pathogenesis of degenerative joint disease outside the spine.

In a recent SPORT subgroup analysis, my coauthors and I found that patients with lumbar stenosis who received ESIs had less improvement compared to control patients who did not receive ESIs. Likely due to the limited biologic and controlled safety data, ESIs are considered an “off-label” procedure because no steroids have been approved by the U.S. Food and Drug Administration for use in the epidural space.

The clinical evidence supporting the use of ESI in lumbar stenosis is very weak. Most of the uncontrolled cohort studies demonstrate improvement but are confounded by the benign natural history of exacerbations of lumbar stenosis. Several prospective, randomized controlled trials (PRCT) have demonstrated no advantage of ESI over saline or local anesthetic injections. Although these studies have been criticized, the best available evidence does not support ESI over placebo. Additionally, ESIs are not without complications. A recent study identified an 11 percent minor complication rate, and major complications such as osteomyelitis have been reported.

Finally, limited observational data suggest that ESIs improve the outcome of lumbar stenosis and contribute to surgical avoidance. If ESIs really contribute to surgical avoidance, then we should see inverse rates of ESIs and surgery in the “real world.” Studies of the Medicare population and the U.S. Veterans Administration database, however, have associated ESIs with higher rates of surgical intervention and opioid use.

The ongoing prospective, randomized studies may answer the question of the role of ESIs in lumbar stenosis. As orthopaedic surgeons, we can and should continue to study this issue. It only took two controversial PRCTs, however, to lead the AAOS to reevaluate vertebroplasty in vertebral compression fractures. How many negative PRCTs will be necessary to encourage spine professionals to reconsider the role of ESIs in spinal stenosis?

Kristen E. Radcliff, MD, is an assistant professor of orthopaedic surgery and neurological surgery at Jefferson Medical College who specializes in minimally invasive and complex spinal reconstruction procedures. He can be reached at radcliffk@gmail.com

Disclosure information: Dr. Radcliff—Globus Medical; Stryker; Medtronic; DePuy, A Johnson & Johnson Company; Synthes; Relievant; Lippincott

References

1. Cummins J, Lurie JD, Tosteson TD, et al: Descriptive epidemiology and prior healthcare utilization of patients in the Spine Patient Outcomes Research Trial's (SPORT) three observational cohorts: Disc herniation, spinal stenosis, and degenerative spondylolisthesis. Spine (Phila Pa 1976) 2006;31(7):806-814.

2. Parke WW, Gammell K, Rothman RH: Arterial vascularization of the cauda equina. J Bone Joint Surg Am 1981;63(1):53-62.

3. Park CH, Lee SH: Prognostic usefulness of high sensitivity C-reactive protein for transforaminal epidural steroid injection in patients with radicular pain. Pain Med 2011;12(2):219-223.

4. Radcliff K, Kepler CK, Hilibrand A, et al: Epidural steroid injections are associated with poorer outcomes in the treatment of lumbar spinal stenosis: A subgroup analysis of the SPORT. Presented at North American Spine Society Annual Meeting 2011.

5. Botwin K, Brown LA, Fishman M, Rao S: Fluoroscopically guided caudal epidural steroid injections in degenerative lumbar spine stenosis. Pain Physician. 2007;10(4):547-558.

6. Botwin KP, Gruber RD, Bouchlas CG, et al: Fluoroscopically guided lumbar transforaminal epidural steroid injections in degenerative lumbar stenosis: An outcome study. Am J Phys Med Rehabil 2002;81(12):898–905.

7. Fukusaki M, Kobayashi I, Hara T, Sumikawa K: Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain 1998;14(2):148–151.

8. Manchikanti L, Cash KA, McManus CD, Pampati V, Abdi S: Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 4. Spinal stenosis. Pain Physician 2008;11(6):833–848.

9. Manchikanti L, Cash KA, McManus CD, Pampati V, Fellows B: Results of 2-year follow-up of a randomized, double-blind, controlled trial of fluoroscopic caudal epidural injections in central spinal stenosis. Pain Physician 2012;15(5):371-384.

10. Benyamin RM, Manchikanti L, Parr AT, et al: The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician 2012;15(4):E363-404.

11. Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: Preliminary results of a randomized, double-blind, active control trial. Pain Physician 2012;15(1):51-63.

12. Manchikanti L, Buenaventura RM, Manchikanti KN, et al: Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician 2012;15(3):E199-245.

13. Karaman H, Kavak GO, Tüfek A, Yldrm ZB: The complications of transforaminal lumbar epidural steroid injections. Spine (Phila Pa 1976) 2011;36(13):E819-824.

14. Simopoulos TT, Kraemer JJ, Glazer P, Bajwa ZH: Vertebral osteomyelitis: A potentially catastrophic outcome after lumbar epidural steroid injection. Pain Physician 2008;11(5):693-697.

15. Riew KD, Yin Y, Gilula L, et al: The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain: A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am 2000;82-A(11):1589-1593.

16. Friedly J, Chan L, Deyo R: Geographic variation in epidural steroid injection use in medicare patients. J Bone Joint Surg Am 2008;90(8):1730-1737.

17. Friedly J, Chan L, Deyo R:. Increases in lumbosacral injections in the Medicare population: 1994 to 2001. Spine (Phila Pa 1976) 2007;32(16):1754-1760.

18. Friedly J, Nishio I, Bishop MJ, Maynard C: The relationship between repeated epidural steroid injections and subsequent opioid use and lumbar surgery. Arch Phys Med Rehabil 2008;89(6):1011-1015.

19. Friedly JL, Bresnahan BW, Comstock B, et al: Study protocol: Lumbar epidural steroid injections for Spinal Stenosis (LESS): A double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord 2012;13:48.

Editor’s note: After these viewpoints were written, reports surfaced of the development of fungal meningitis among patients who received epidural steroid injections prepared using preservative-free methylprednisone acetate [80 mg/mL] from the New England Compounding Center, Framingham, Mass. As a result, patients may be have questions or concerns about receiving steroid injections. AAOS members are encouraged to check the source of their steroids and to read the AAOS patient safety member alert, available online at http://www3.aaos.org/member/safety/psmo/psmoalert/meningitis.cfm