Clinical UM Guideline
|Subject:||Pain Management: Epidural Steroid Injections|
|Guideline #:||CG-SURG-39||Current Effective Date:||04/05/2016|
|Status:||Revised||Last Review Date:||02/04/2016|
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:
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:
*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:
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.
|62310||Injection(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]|
|62311||Injection(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]|
|64479||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level|
|64480||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional level|
|64483||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level|
|64484||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level|
|0228T||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, cervical or thoracic; single level|
|0229T||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, cervical or thoracic; each additional level|
|0230T||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, lumbar or sacral; single level|
|0231T||Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, lumbar or sacral; each additional level|
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:
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.
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.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
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.
|Revised||02/04/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Clarified criteria. Updated Discussion/General Information, Reference and Website sections. Removed ICD-9 codes from Coding section.|
|Revised||08/06/2015||MPTAC review. Clarified definition of conservative therapy in criteria. Updated Discussion/General Information, References and Website Sections.|
|Revised||02/05/2015||MPTAC review. Revised Title. Clarified Not Medically Necessary statement. Updated Description, Discussion/General Information and Reference sections.|
|Reviewed||02/13/2014||MPTAC review. Updated Coding, Description and Websites sections.|
|New||11/14/2013||MPTAC review. Initial document development.|