Clinical UM Guideline


Subject:  Pain Management: Epidural Steroid Injections
Guideline #:  CG-SURG-39Current Effective Date:  04/05/2016
Status:RevisedLast Review Date:  02/04/2016

Description

This document addresses epidural steroid injections (ESIs) with or without anesthetic agents. ESIs are a technique used to treat radicular pain, such as sciatica. This document does not address epidural anesthesia (administered to manage pain during childbirth and surgical procedures), facet joint injections or sacroiliac joint injections.

Note: Please see the following related documents for additional information:

Clinical Indications

Medically Necessary:

ESI of the cervical or lumbar spine, with or without added anesthetic agents, may be medically necessary when all of the following criteria are met:

  1. The individual has radicular pain; and
  2. The pain is interfering with functional activities; and
  3. The pain has not responded to 6 weeks of appropriate conservative therapy*; and
  4. There is no evident systemic infection or local infection at the injection site, bleeding tendency, or unstable medical condition; and
  5. A single ESI may be repeated up to 4 times per spinal region (cervical or lumbar regions only) within a 12 month time-frame with at least 1 week between each injection, so long as the prior injection in that spinal region produced at least partial symptomatic relief.

*Note: Conservative therapy consists of an appropriate combination of medication (for example, NSAIDs, analgesics, etc.) in addition to physical therapy, spinal manipulation therapy, cognitive behavioral therapy (CBT) or other interventions based on the individual's specific presentation, physical findings and imaging results.

Not Medically Necessary:

ESIs are considered not medically necessary when the criteria specified above are not met, and for all other indications including, but not limited to:

  1. ESI at a thoracic spinal level
  2. ESI is used for treatment of non-radicular spinal pain, myofascial pain syndrome, spinal stenosis, or post herpetic neuralgia
  3. Repeat ESI performed in the absence of documented improvement in pain or function upon reassessment
  4. Repeat ESI performed more frequently than once weekly
  5. More than 4 ESI injections at the same spinal region within a 12 month time-frame.
Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
62310Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic [when specified as epidural steroid injection]
62311Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) [when specified as epidural steroid injection]
64479Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level
64480Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional level
64483Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level
64484Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level
0228TInjection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, cervical or thoracic; single level
0229TInjection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, cervical or thoracic; each additional level
0230TInjection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, lumbar or sacral; single level
0231TInjection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, lumbar or sacral; each additional level
  
ICD-10 Diagnosis 
 All diagnoses
  
Discussion/General Information

Acute pain caused by spinal injury, surgery, or illness is usually self-limited and disappears when the underlying cause has been treated or has healed. Conversely, chronic pain can persist despite the fact that the cause (for example, injury or disease) has resolved. The intensity of chronic pain can vary from mild to severely disabling pain that may have a significant, negative impact on one's quality of life. Management of chronic pain presents a major challenge to healthcare providers because of its complex natural history and unclear etiology. Furthermore, clinical decision making for diagnosing and treating chronic pain is difficult due to the subjective nature of pain. The results of clinical studies of ESIs vary with respect to design and the degree and duration of pain relief, further complicating the standardization of treatment modalities.

Injections for Cervical and Lumbar Radiculopathy

One type of treatment of cervical and lumbar radicular pain (such as sciatica) is ESI. ESI uses corticosteroids, either alone or in combination with anesthetic agents to target the epidural space that is localized to the area of affected nerve roots. According to the American Academy of Orthopaedic Surgeons (AAOS, 2009) "Most spinal injections are performed as one part of a more comprehensive treatment program. Simultaneous treatment nearly always includes an exercise program to improve or maintain spinal mobility (stretching exercises) and stability (strengthening exercises)." The American Society of Anesthesiologists (ASA; 1997) has stated that the goals of pain management are to:

In a 2008 update of a Cochrane Database Systematic Review on Injection Therapy for Subacute and Chronic Low-back Pain, Staal and associates stated that the effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis. However, it cannot be ruled out that specific subgroups of individuals may respond to a specific type of injection therapy. The authors conclude, "…there is no strong evidence for or against the use of any type of injection therapy for individuals with subacute or chronic low-back pain."

In 2011, The North American Spine Society (NASS) published a Review and Recommendation Statement entitled Cervical Epidural Steroid Injections. The review states that:

There is fairly consistent Level III and IV evidence that transforaminal and interlaminar cervical epidural steroid injections (CESI) provide relief in 60-70% of patient with cervical radiculitis. This treatment seems to be fairly well maintained over time as demonstrated in studies with greater than one year follow-up. There were no studies available comparing the efficacy of interlaminar injections to transforaminal injections.

The review did not addresses procedural practices for ESIs or the appropriate number or frequency of injections and stated that there was little evidence that addressed these questions for the treatment of cervical pain.

Similarly, in 2013 NASS published a Review and Recommendation Statement entitled Lumbar Transforaminal Epidural Steroid Injections. A grade A recommendation (defined as good evidence) was given for the effectiveness of ESI at treating radicular pain related to lumbar disc herniation for at least 1 month in more than 50% of individuals. The review graded the evidence as insufficient for a recommendation to treat lumbar radicular pain in the presence of stenosis. There was insufficient evidence to provide an evidence-based recommendation on the maximum number of lumbar ESIs that are appropriate in any given time-frame or the amount of pain/functional improvement needed to justify repeat injections.

Chou and colleagues (2009) evaluated clinical data for the American Pain Society's Clinical Practice Guideline: Nonsurgical Interventional Therapies for Low Back Pain. They found that evidence from randomized, placebo controlled trials showing benefit of interventional injection therapies for back pain are limited. For radiculopathy, there is fair evidence of benefits associated with ESI; however, the decision to use ESI should take into account the short-term nature of symptom relief and inconsistent results of epidural steroid trials. A systematic review conducted by Pinto and colleagues (2012), similarly concluded that the clinical utility of ESIs in lower back pain management lies in their ability to relieve radicular pain in the short-term (2-12 weeks), demonstrated from results of 23 randomized placebo-controlled clinical trials.

Datta and colleagues (2013) sought to better define the role of injection therapy for diagnostic purposes and conducted a systematic review of their use in the diagnosis of lower back and lower extremity pain. They concluded that the evidence is limited and additional research and consensus is warranted to further clarify the role of epidural injections as a diagnostic tool.

Injections for Thoracic Radiculopathy

A preliminary report by Manchikanti and colleagues (2010) evaluated the safety and effectiveness of thoracic epidural injections in 40 participants who underwent treatment for relief of chronic mid and upper back pain secondary to radiculitis or disc herniation with local anesthetic alone or local anesthetic with steroids. At 12 months, 80% of participants in the anesthetic-alone group reported at least 50% pain reduction while 85% receiving local anesthetic plus steroid reported at least 50% pain reduction (p-value not reported). This pilot study was small and lacked a sham control group to measure treatment effect.

A randomized, double-blind, controlled trial was conducted by Manchikanti and colleagues (2014), evaluating the efficacy of thoracic ESI. A total of 110 participants were enrolled in 1 of 2 groups; Group 1 received only a local anesthetic and Group 2 received a local anesthetic and steroid. Primary outcomes of the study included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI) 2.0, employment status and opioid use. Significant improvement was defined as 50% or greater decrease in NRS and ODI scores. Follow-up occurred at 3, 6, 12, 18 and 24 months. Both the "successful" and "unsuccessful" treatments in Groups 1 and 2 showed significant improvement from baseline at 3 months up through study end at 2 years. However, the lack of a control arm or between group comparisons precludes a definitive determination of causality.

Injections for Spinal Stenosis

Currently, there is limited evidence to support the use of ESIs in the treatment of spinal stenosis. Guidelines from the American Pain Society (2009) concluded that there is "Insufficient evidence to adequately evaluate the benefits and harms of epidural steroid injections for spinal stenosis."

Manchikanti and colleagues (2012) reported results from a double-blind sham controlled study of 100 participants who underwent lumbar epidural injections of local anesthetic with steroids (Group I; n=50) or without steroids (Group II; n=50) for chronic function-limiting lower back pain and lower extremity pain secondary to spinal stenosis. The authors reported:

…significant pain relief and functional status improvement were seen in 50% in group I and 57% in group II at the end of 2 years in a subset ("the successful group") of participants. However, overall significant pain relief and functional status improvement (greater than or equal to 50%) was demonstrated in 38% of group I and 44% in group II at the end of 2 years.

Limitations of the study included its small size and a modest treatment effect in a minority of participants.

The lumbar ESIs for spinal stenosis (LESS) study (Friedly and colleagues study protocol, 2012) is arandomized, double-blind trial evaluating the effectiveness of ESIs in improving pain and function among older adults with lumbar spinal stenosis. The trial completion was completed in 2015 but study results are not yet published. Preliminary data was published from the first 400 participants that were enrolled. The authors' preliminary conclusions at 6-week follow-up from this large, randomized, double-blind trial stated, "In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone" (Friedly, 2014). A limitation of this study is the lack of a control arm.

NASS in its Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis 2011 states: "Interlaminar epidural steroid injections are suggested to provide short-term (two weeks to six months) symptom relief in patients with neurogenic claudication or radiculopathy. There is, however, conflicting evidence concerning long-term (21.5-24 months) efficacy." Although the grade of this recommendation was given a B (denotes a "suggested" recommendation), the level of evidence presented to support it consisted largely of levels of evidence, III and IV, which by definition are non-randomized, case-series, retrospective, or possess a methodological flaw. The only study with a level of evidence II was published by Fukusaki in 1998 and included 53 participants. Significant differences in pain improvement were (lesser quality RCTs, retrospective studies or systematic reviews) seen in the anesthetic and steroid groups over the saline group at 1 month follow-up. However, there was no significant difference between the anesthetic and steroid group; therefore, ESI did not provide an additional, demonstrable clinical benefit in pain management. Furthermore, at 3 months no significant difference remained between all 3 study arms.

NASS's recommendations for future research (2011) include:

  1. A large double-masked, randomized, controlled clinical trial with at least one-year follow-up in patients with unilateral leg pain from lumbar spinal stenosis treated by fluoroscopically-guided contrast-enhanced transforaminal epidural steroid injections in which the control group receives saline placebo injections.
  2. A large double-masked, randomized, controlled clinical trial with at least two-year follow-up in patients with neurogenic claudication from lumbar spinal stenosis treated by fluoroscopically-guided interlaminar or caudal epidural steroid injections in which the control group receives saline placebo injections.

A recent Cochrane review assessing the evidence for non-surgical treatment approaches for spinal stenosis concluded, "Moderate and high-quality evidence for non-operative treatment is lacking and thus prohibits recommendations for guiding clinical practice. Given the expected exponential rise in the prevalence of lumbar spinal stenosis with neurogenic claudication, large high-quality trials are urgently needed" (Ammendolia, 2013).

A technology assessment published by the Agency for Healthcare Research and Quality (AHRQ, 2015) conducted a systematic review of injection therapies for lower back pain which included 78 randomized trials of epidural steroid injections. The publication concluded:

Epidural corticosteroid injections for radiculopathy were associated with immediate improvements in pain and might be associated with immediate improvements in function, but benefits were small and not sustained, and there was no effect on long-term risk of surgery. Evidence did not suggest that effectiveness varies based on injection technique, corticosteroid, dose, or comparator. Limited evidence suggested that epidural corticosteroid injections are not effective for spinal stenosis or nonradicular back pain…

Injections for Herpetic Neuralgia

van Wijck and colleagues (2006) reported results of the PINE study of epidural steroids and local anesthetics to prevent post-herpetic neuralgia. In an RCT, 598 participants with acute herpes zoster either received standard therapy (oral antivirals and analgesics) or standard therapy and one additional ESI. After 1-, 3- and 6-month evaluations, they found that an epidural injection had a modest effect in reducing zoster associated pain after only 1 month and that this treatment is not effective for prevention of long-term post-herpetic neuralgia.

Definitions

Non-radicular back pain: Pain which does not radiate along a dermatome (sensory distribution of a single root). Appropriate imaging does not reveal signs of spinal nerve root compression and there is no evidence of spinal nerve root compression seen on clinical exam.

Radicular back pain: Pain which radiates along a dermatome (sensory distribution of a single root) into an upper or lower extremity. Evidence of spinal nerve root compression may be seen on clinical exam and supported by appropriate imaging (generally Magnetic Resonance Imaging [MRI]) studies.

Radiculopathy:Radiculopathy is characterized by pain which radiates from the spine to extend outward to cause symptoms away from the source of the spinal nerve root irritation.

Straight Leg Raise Test: In the supine position, the leg is elevated with the knee held in extension, by the clinician, up to 70 degrees; a positive test reproduces radicular pain along the path of a nerve root in the 30- to 70-degree range of elevation.

References

Peer Reviewed Publications:

  1. Bicket MC, Horowitz JM, Benzon HT, Cohen SP. Epidural injections in prevention of surgery for spinal pain: systematic review and meta-analysis of randomized controlled trials. Spine J. 2015; 15 (2):348-362.
  2. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). 2009; 34(10):1078-1093.
  3. Cohen SP, Hanling S, Bicket MC et al. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study. BMJ. 2015; 350:h1748.
  4. Datta S, Manchikanti L, Falco FJ, et al. Diagnostic utility of selective nerve root blocks in the diagnosis of lumbosacral radicular pain: systematic review and update of current evidence. Pain Physician. 2013; (2 Suppl): SE97-124.
  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 Musculoskeletal Disorders. 2012; 13:48.
  6. Friedly JL, Comstock BA, Turner JA, et al. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. 2014; 371(1):11-21.
  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. Jaimes R, Rocco AG. Multiple epidural steroid injections and body mass index linked with occurrence of epidural lipomatosis: a case series. BMC Anesthesiol. 2014; 14:70.
  9. Jørgensen SH, Ribergaard NE, Al-Kafaji OH, Rasmussen C. Epidural steroid injections in the management of cervical disc herniations with radiculopathy. Scand J Rheumatol. 2015; 44(4):315-320.
  10. Kranz PG, Amrhein TJ, Gray L. Incidence of inadvertent intravascular injection during CT fluoroscopy-guided epidural steroid injections. AJNR Am J Neuroradiol. 2015; 36(5):1000-1007.
  11. Manchikanti L, Cash KA, McManus CD, et al. A preliminary report of a randomized double-blind, active controlled trial of fluoroscopy thoracic interlaminar epidural injections in managing chronic thoracic pain. Pain Physician. 2010; 13(6):E357-369.
  12. Manchikanti L, Cash KA, McManus CD, et al. 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.
  13. McCormick Z, Cushman D, Casey E, et al. Factors associated with pain reduction after transforaminal epidural steroid injection for lumbosacral radicular pain. Arch Phys Med Rehabil. 2014; 95(12):2350-2356.
  14. Miller T, Burns J, Gilligan J, et al. Patients with refractory back pain treated in the emergency department: is immediate interlaminar epidural steroid injection superior to hospital admission  and standard medical pain management? Pain Physician. 2015; 18(2):E171-E176.
  15. Pinto RZ, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012; 157(12):865-877.
  16. van Wijck AJ, Opstelten W, Moons KG, et al. The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia: a randomized controlled trial. Lancet. 2006; 367(9506):219-224.
  17. Young IA, Hyman GS, Packia-Raj LN, Cole AJ. The use of lumbar epidural/transforaminal steroids for managing spinal disease. J Am Acad Orthop Surg. 2007; 15(4):228-238.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality (AHRQ). Pain management injection therapies for low back pain. 2015 March. Technology Assessment Report ESIB081. Available at: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/id98TA.pdf. Accessed on December 17, 2015.
  2. American Pain Society (APS) and American Academy of Pain Medicine (ASPM). Clinical guideline for the evaluation and management of low back pain: Evidence review. 2009. Available at: http://americanpainsociety.org/uploads/education/guidelines/evaluation-management-lowback-pain.pdf. Accessed on December 17, 2015.
  3. American Pain Society Low Back Pain Guideline Panel. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine. 2009; 34(10):1066-1077.
  4. American Society of Anesthesiologists (ASA). Task force on pain management: General practice guidelines for chronic pain management. Anesthesiology 1997; 86(4):995-1004.
  5. American Society of Anesthesiologists. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010; 112(4):810-833.
  6. Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev. 2013; (8):CD010712.
  7. Institute for Clinical Systems Improvement (ISCI). Health care guideline: Adult acute and subacute low back pain. 2011. Available at: https://www.icsi.org/_asset/bjvqrj/LBP.pdf. Accessed on December 17, 2015.
  8. North American Spine Society (NASS). Cervical epidural steroid injections: Review and recommendation statement. NASS. 2011. Available at:  https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/CESIReviewRecStatement.pdf. Accessed on December 17, 2015.
  9. North American Spine Society (NASS). Clinical guidelines for diagnosis and treatment of lumbar disc herniation with radiculopathy. NASS. 2012. Available at:  https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarDiscHerniation.pdf. Accessed on December 17, 2015.
  10. North American Spine Society (NASS). Clinical guidelines for multidisciplinary spine care. diagnosis and treatment of degenerative lumbar spinal stenosis. NASS. 2011. Available at:  https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf. Accessed on December 17, 2015.
  11. North American Spine Society (NASS). Lumbar transforaminal epidural steroid injections: Review and recommendation statement. NASS. 2013. Available at:  https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/LTFESIReviewRecStatement.pdf. Accessed on December 17, 2015.
  12. Pain Management Center of Paducah. Treatment of chronic thoracic and neck and upper extremity pain. NLM identifier: NCT01071369. Last updated on October 20, 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT01071369. Accessed on December 17, 2015.
  13. Rathmell JP, Benzon HT, Dreyfuss P, et al. Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations. Anesthesiology. 2015; 122(5):974-984.
  14. Resnick D, Choudhri T, Dailey A, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain and lumbar fusion. J Neurosurg: Spine 2005; 2(636):707-715.
  15. Staal JB, de Bie R, de Vet HC, et al. Update of: Cochrane Database Syst Rev. 2000; (2):CD001824. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008; (3):CD001824.
  16. University of Washington. Lumbar epidurals injections for spinal stenosis multicenter randomized, controlled trial (LESS Trial). NLM identifier: NCT01238536. Last updated on December 03, 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT01238536. Accessed on December 17, 2015.
Websites for Additional Information
  1. American Academy of Orthopaedic Surgeons. Spinal injections. Last updated on December 2013. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00560. Accessed on December 17, 2015.
  2. MedlinePlus. Back pain. Last updated on June 10, 2015. Available at: http://www.nlm.nih.gov/medlineplus/backpain.html. Accessed on December 17, 2015.
  3. MedlinePlus. Epidural injections for back pain. Last updated on June 15, 2015. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007485.htm. Accessed on December 17, 2015.
  4. Medscape. Epidural steroid injections. December 23, 2014. Available at: http://emedicine.medscape.com/article/325733-overview. Accessed on December 17, 2015.
Index

Anti-inflammatory
Epidural injection
Steroid injection

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Revised02/04/2016Medical Policy & Technology Assessment Committee (MPTAC) review. Clarified criteria. Updated Discussion/General Information, Reference and Website sections. Removed ICD-9 codes from Coding section.
Revised08/06/2015MPTAC review. Clarified definition of conservative therapy in criteria. Updated Discussion/General Information, References and Website Sections.
Revised02/05/2015MPTAC review. Revised Title. Clarified Not Medically Necessary statement. Updated Description, Discussion/General Information and Reference sections.
Reviewed02/13/2014MPTAC review. Updated Coding, Description and Websites sections.
New11/14/2013MPTAC review. Initial document development.