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1 National Medical Policy Subject: Epidural Steroid Injections for Treatment of Low Back and Cervical Pain Policy Number: NMP487 Effective Date*: July 2003 Updated: October 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Epidural and Transforaminal Epidural Injections; Lumbar Epidural Injections; Nerve Blockade for Treatment of Chronic Pain and Neuropathy: Article (Local)* X Other MLN Matters Number: SE1102 Revised August 14, 2012: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/se1102.pdf None Use Health Net Policy Instructions Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 1

2 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers epidural steroid injections (e.g., Depo-Medrol), often with a local anesthetic (e.g., lidocaine), medically necessary for treatment of acute (< 3 months) low back or cervical pain when all of the following are met: 1. The pain symptoms are radicular in nature (usually associated with a herniated nucleus pulposus) as evidenced by physical examination, MRI/CT imaging, EMG or nerve conduction studies; and 2. Non-spinal origin for pain, intraspinal tumor or other space-occupying lesion has been ruled out by MRI/CT imaging as the cause of pain; and 3. A trial of conservative measures (e.g., rest/limited activity, NSAIDS, systemic analgesics, and/or physical therapy) for at least 6 weeks has failed or is not feasible because the patient's pain is too severe*; and 4. There are no contraindications to receiving an epidural steroid injection, such as: Allergy to the medication to be administered, or A significantly altered or eliminated epidural space (e.g., congenital anatomic anomalies, spinal cord compression or previous surgery), or Anticoagulation therapy, or Bleeding disorder, or Clinically significant spinal stenosis at the site of planned injection, or Localized infection in the region to be injected, or Systemic infection, or Other co-morbidities which could be exacerbated by steroid usage (e.g., poorly controlled hypertension, severe congestive heart failure, diabetes, etc.). * Note: Other indications include: 1. When pain relief is necessary for participation in physical therapy that would facilitate a return to activities of daily living to fulfill this criterion, a referral to a physical therapist is necessary and he/she must submit a written statement to confirm that such is the case; or Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 2

3 2. Patient has radicular pain with surgically correctable lesion(s), but who is not a surgical candidate Notes: 1. Standard medical practice dictates that if a therapeutic series of up to 3 injections have been given without significant relief of low back or cervical pain, then further epidural administrations are not medically necessary. 2. Generally, only up to 6 injections within a 12-month period are medically necessary in order to minimize the risks from large doses of steroids (does not take into account 1 or 2 diagnostic steroid injections). 3. Patients who relapse after a satisfactory response may be candidates for another trial after an interval of at least six months. In selected cases, where more definitive therapies (e.g., surgery) cannot be tolerated or provided, additional injections may be medically necessary. Health Net, Inc. considers any of the following uses of epidural steroids not medically necessary, given the lack of available evidence for effectiveness in the medical literature: 1. Progressive neurologic deficits; or 2. Chronic persistent or recurrent radicular low back or cervical pain lasting > 3 months; or 3. Chronic spinal pain without radiculopathy; or 4. Epidural steroid injection for thoracic pain; or 5. Myofascial pain syndrome; or 6. Facet and sacroiliac arthropathy (even when accompanied by pain that radiates into an extremity); or 7. Post lumbar laminectomy syndrome; or 8. Post-herpetic and post-traumatic neuralgia. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes Lumbosacral root lesions, not elsewhere classified Neuralgic amyotrophy Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 3

4 353.8 Other nerve root and plexus disorders Mononeuritis, upper limb Mononeuritis, lower limb Intervertebral disc disorders Other disorders of cervical region Other and unspecified disorders of the back Sciatica Lumbosacral neuritis or radiculitis, unspecified Neuralgia, neuritis, and radiculitis, unspecified ICD-10 Codes G54.1-G54.4 Nerve root and plexus disorders, Lumbosacral, cervical and thoracic G54.8-G54.9 Other nerve root and plexus disorders M48.02-M48.08 Spinal stenosis (i.e., cervical, cervicothoracic, thoracic, thoracolumbar, lumbar, lumbosacral, sacral and sacrococcygeal region) M54.10-M54.18 Radiculopathy M54.2 Cervicalgia M54.5-M54.9 Low back pain, pain in thoracic spine, dorsalgia CPT Codes Injection, single (not via indwelling catheter), not including neurolytic substances, with or without contrast (for either localization or epidurography), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), epidural or subarachnoid; cervical or thoracic lumbar, sacral (caudal) HCPCS Codes N/A Scientific Rationale Update October 2015 Meng et al (2015) performed a meta-analysis of how epidural injections of anesthetic with steroids compare with those using local anesthetic alone. The authors included 13 randomized controlled trials, involving 1,465 patients. Significant pain relief ( 50%) was demonstrated in 53.7% of patients administered with epidural injections of anesthetic with steroids (group 1) and in 56.4% of those administered with local anesthetic alone (group 2). Patients showed a reduction in numeric rating scale pain score of 3.7 and 3.6 in the two groups, respectively. Significant functional improvement was achieved in 65.2% of patients in group 1 and 63.1% of patients in group 2, with Oswestry Disability Index reductions of 13.8 and 14.5 points, respectively. The overall number of injections per year was 3.2±1.3 and 3.4±1.2 with average total relief per year of 29.3±19.7 and 33.8±19.3 weeks, respectively. The opioid intakes decreased from baseline by 12.4 and 7.8 mg, respectively. Among the outcomes listed, only total relief time differed significantly between the two groups. The reviewers concluded both epidural injections with steroids or with local anesthetic alone provide significant pain relief and functional improvement in managing chronic low back pain secondary to lumbar spinal stenosis, and the inclusion of steroids confers no advantage compared to local anesthetic alone. Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 4

5 Zhai et al (2015) conducted a meta-analysis to assess the effects of various surgical and nonsurgical modalities, including epidural injections, used to treat lumbar disc herniation (LDH) or radiculitis. A systematic literature search was conducted to identify randomized controlled trials (RCTs) which compared the effect of local anesthetic with or without steroids. The outcomes included pain relief, functional improvement, opioid intake, and therapeutic procedural characteristics. Pooled estimates were calculated using a random-effects or fixed-effects model, depending on the heterogeneity between the included studies. 10 RCTs (involving 1111 patients) were included in this meta-analysis. The pooled results showed that 41.7% of patients who received local anesthetic with steroid (group 1) and 40.2% of patients who received local anesthetic alone (group 2) had significant improvement in pain relief. And the Numeric Rating Scale pain scales were significantly reduced by 4.09 scores (95% CI: -4.26, -3.91), and 4.12 (95% CI: -4.35, -3.89) scores, respectively. Similarly, 39.8% of patients in group 1 and 40.7% of patients in group 2 achieved significantly improved functional status. The Oswestry Disability Index in the two groups were reduced by 14.5 (95% CI: , ) and (95% CI: , -8.62), respectively. The average procedures per year in group 1 was 3.68 ± 1.17 and 3.68 ± 1.26 in group 2 with an average total relief per year of ± weeks and ± weeks, respectively. The opioid intake decreased from baseline by 8.81 mg (95% CI: , -5.38) and mg (95% CI: , ) in the two groups, respectively. The reviewers concluded the meta-analysis confirms that epidural injections of local anesthetic with or without steroids have beneficial but similar effects in the treatment of patients with chronic low back and lower extremity pain. Leung et al (2015) sought to identify the diagnostic, therapeutic, and prognostic values of transforaminal epidural steroid injection as interventional rehabilitation for lumbar radiculopathy in a case series. A total of 232 Chinese patients with lumbar radiculopathy attributed to disc herniation or spinal stenosis received transforaminal epidural steroid injection between 1 January 2007 and 31 December Patients' immediate response, response duration, proportion of patients requiring surgery, and risk factors affecting the responses to transforaminal epidural steroid injection for lumbar radiculopathy. Of the 232 patients, 218 (94.0%) had a single level of radiculopathy and 14 (6.0%) had multiple levels. L5 was the most commonly affected level. The immediate response rate to transforaminal epidural steroid injection was 186 (80.2%) patients with clinically diagnosed lumbar radiculopathy and magnetic resonance imaging of the lumbar spine suggesting nerve root compression. Of patients with single-level radiculopathy and multiple-level radiculopathy, 175 (80.3%) and 11 (78.6%) expressed an immediate response to transforaminal epidural steroid injection, respectively. The analgesic effect lasted for 1 to <3 weeks in 35 (15.1%) patients, for 3 to 12 weeks in 37 (15.9%) patients, and for more than 12 weeks in 92 (39.7%) patients. Of the 232 patients, 106 (45.7%) were offered surgery, with 65 (61.3%) underwent operation, and with 42 (64.6%) requiring spinal fusion in addition to decompression surgery. Symptom chronicity was associated with poor immediate transforaminal epidural steroid injection response, but not with pain reduction response duration. Poor response to transforaminal epidural steroid injection was not associated with a preceding industrial injury. The authors concluded the immediate response to transforaminal epidural steroid injection was approximately 80%. Transforaminal epidural steroid injection is a useful diagnostic, prognostic, and short-term therapeutic tool for lumbar radiculopathy. Although transforaminal epidural steroid injection cannot alter Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 5

6 the need for surgery in the long term, it is a reasonably safe procedure to provide short-term pain relief and as a preoperative assessment tool. Niemer et al (2015) postulated that a diseased disc results in a local inflammatory reaction therefore causing pain and impairing treatability of patients. An epidural injection of steroids can reduce inflammation and therefore improve treatability and ultimately treatment outcome. A double blind randomized prospective trial was carried out. Patients treated in hospital for a chronic lumbar pain syndrome without neurological deficits within a multimodal treatment program were screened for indications for an epidural steroid injection (e.g. diseased lumbar disc and intention to treat). Patients eligible for the study were randomized into two groups. The treatment group received an epidural injection of 80 mg triamcinolone and 8 ml bupivacaine 0.25%. The control group received only an epidural injection of 8 ml bupivacaine 0.25%. In both groups pain intensity and treatability showed a statistically significant improvement after the epidural injection. The differences between the control and treatment groups were small and not clinically relevant. A small subgroup might profit from the steroid injection. In addition the treatability was dependent on psychometric values and the long-term outcome from a reduction of muscular skeletal dysfunctions. The authors concluded after the epidural injection the decrease in pain and increase in treatability was statistically significant. The mechanism of the improvement is not clear and should be examined further. The epidural injection of a steroid in this subgroup of patients did not lead to a clinical improvement in the outcome. Turner et al (2015) sought to identify patient characteristics associated with benefits from epidural injections of corticosteroid with lidocaine versus epidural injections of lidocaine only for lumbar spinal stenosis symptoms. This was a secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data from 16 US clinical sites. Patients aged older than or equal to 50 years with moderate-to-severe leg pain and lumbar central spinal stenosis randomized to epidural injections of corticosteroids with lidocaine (n=200) or lidocaine only (n=200) were included. Primary outcomes were the Roland-Morris Disability Questionnaire (RMDQ) and 0 to 10 leg pain intensity ratings. Secondary outcomes included the Brief Pain Inventory Interference Scale and the Swiss Spinal Stenosis Questionnaire. At baseline, clinicians rated severity of patient spinal stenosis, and patients completed predictor and outcome measures. Patients completed outcome measures again 3 and 6 (primary end point) weeks after randomization/initial injection. Analysis of covariance was used with treatment by covariate interactions to identify baseline predictors of greater benefit from corticosteroid+lidocaine versus lidocaine alone. The authors also identified nonspecific (independent of treatment) predictors of outcomes. Among 21 candidate predictors and six outcomes, only one baseline variable predicted greater benefit from corticosteroid+lidocaine versus lidocaine only at 3 or 6 weeks. Compared with patients who rated their healthrelated quality of life as high on the EQ-5D Index, patients who rated it as poor had greater improvement with corticosteroid than with lidocaine only in leg pain at 6 (but not 3) weeks (interaction coefficient=2.94; 95% confidence interval [CI]= ; p=.04) and in RMDQ disability scores at 3 (but not 6) weeks (interaction coefficient=4.77, 95% CI= to 9.59; p =.05). Several baseline patient characteristics predicted outcomes regardless of treatment assignment. The authors concluded among 21 baseline patient characteristics examined, none, including clinician-rated spinal stenosis severity, were consistent predictors of benefit from epidural injections of lidocaine+corticosteroid versus lidocaine only. Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 6

7 Manchikanti et al (2015) assessed the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 ml, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 ml mixed with 1 ml of steroids and 6 mg of betamethasone. Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. The authors concluded lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis. Cohen et al (2014) performed a comparative-effectiveness study in 169 patients with cervical radicular pain less than 4 yr in duration. Participants received nortriptyline and/or gabapentin plus physical therapies, up to three cervical epidural steroid injections (ESI) or combination treatment over 6 months. The primary outcome measure was average arm pain on a 0 to 10 scale at 1 month. One-month arm pain scores were 3.5 (95% CI, 2.8 to 4.2) in the combination group, 4.2 (CI, 2.8 to 4.2) in ESI patients, and 4.3 (CI, 2.8 to 4.2) in individuals treated conservatively (P = 0.26). Combination group patients experienced a mean reduction of -3.1 (95% CI, to -2.3) in average arm pain at 1 month versus -1.8 (CI, -2.5 to -1.2) in the conservative group and -2.0 (CI, -2.7 to -1.3) in ESI patients (P = 0.035). For neck pain, a mean reduction of -2.2 (95% CI, -3.0 to -1.5) was noted in combination patients versus -1.2 (CI, -1.9 to -0.5) in conservative group patients and -1.1 (CI, to -0.4) in those who received ESI; P = 0.064). Three-month posttreatment, 56.9% of patients treated with combination therapy experienced a positive outcome versus 26.8% in the conservative group and 36.7% in ESI patients (P = 0.006). The authors concluded for the primary outcome measure, no significant differences were found between treatments, although combination therapy provided better improvement than stand-alone treatment on some measures. Whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes, confirmatory studies are needed. Scientific Rationale Update October 2014 The debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Epidural glucocorticoid injections have been used for pain control in patients with radiculopathy, spinal stenosis, and nonspecific low Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 7

8 back pain despite inconsistent results as well as heterogeneous populations and interventions in randomized trials. Generally, candidates for epidural steroid injection are individuals who have acute radicular symptoms or neurogenic claudication unresponsive to traditional analgesics and rest, with significant impairment in activities of daily living. Epidural steroid injections have been used in the treatment of spinal stenosis for many years, and no validated long-term outcomes have been reported to substantiate their use. However, significant improvement in pain scores, have been reported at 3 months. Patients with a healthier emotional status and those with a higher body mass index reportedly experience more pain relief. In April 2014, the U.S. Food and Drug Administration (FDA) warned, that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. They noted the effectiveness and safety of epidural administration of corticosteroids have not been established, and the FDA has not approved corticosteroids for this use. FDA is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe these risks. The FDA recommends that individuals should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. Guidelines on chronic spinal pain from the American Society of Interventional Pain Physicians reported by Manchikanti et al (2013) state that the evidence for caudal epidural, interlaminar epidural, and transforaminal epidural injections is good in managing disc herniation or radiculitis; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal and lumbar interlaminar epidural injections, and limited with transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. The guideline noted further, the recommendation for epidural injections for disc herniation is that one of the 3 approaches may be used; for spinal stenosis any of the 3 approaches are recommended; whereas for axial or discogenic pain, either lumbar interlaminar or caudal epidural injections are recommended. However for transforaminal the evidence is limited for axial or discogenic pain and post surgery syndrome. Regarding cervical interlaminar epidural injections, the guideline noted the evidence is good for cervical disc herniation or radiculitis; whereas it is fair for axial or discogenic pain, pain of spinal stenosis, and pain of post cervical surgery syndrome. Cervical interlaminar epidural injections are recommended for patients with chronic neck and upper extremity pain secondary to disc herniation, spinal stenosis, and post cervical surgery syndrome. Manchikanti et al (2014) sought to assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. One hundred twenty patients were randomly assigned to 2 groups: Group I received 1.5 ml of 1% preservative-free lidocaine, followed by 0.5 ml of sodium chloride solution. Group II received 1% lidocaine, followed by 3 mg, or 0.5 ml of betamethasone. The sodium chloride solution and betamethasone were either clear liquids or were provided in opaque-covered syringes. The primary outcome measure was significant improvement (at least 50%) measured by the average Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 8

9 measures were employment status and opioid intake. At 2 years there was significant improvement in all participants in 65% who received local anesthetic alone and 57% who received local anesthetic and steroid. When separated into nonresponsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures, significant improvement (at least 50% improvement in pain and function) was seen in 80% in the local anesthetic group and 73% in the local anesthetic with steroid group. Presumed limitations of this evaluation include the lack of a placebo group. The authors concluded transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up. Murthy et al (2014) sought to determine if repeat lumbar transforaminal epidural steroid injections (TFESIs) resulted in recovery of pain relief, which has waned since an index injection, and if cumulative benefit could be achieved by repeat injections within 3 months of the index injection in a retrospective observational study with statistical modeling of the response to repeat TFESI. Two thousand eighty-seven single-level TFESIs were performed for radicular pain on 933 subjects. Subjects received repeat TFESIs >2 weeks and <1 year from the index injection. Hierarchical linear modeling was performed to evaluate changes in continuous and categorical pain relief outcomes after repeat TFESI. Subgroup analyses were performed on patients with <3 months duration of pain (acute pain), patients receiving repeat injections within 3 months (clustered injections), and in patients with both acute pain and clustered injections. Repeat TFESIs achieved pain relief in both continuous and categorical outcomes. Relative to the index injection, there was a minimal but statistically significant decrease in pain relief in modeled continuous outcome measures with subsequent injections. Acute pain patients recovered all prior benefit with a statistically significant cumulative benefit. Patients receiving clustered injections achieved statistically significant cumulative benefit, of greater magnitude in acute pain patients. The reviewers concluded repeat TFESI may be performed for recurrence of radicular pain with the expectation of recovery of most or all previously achieved benefit; acute pain patients will likely recover all prior benefit. Repeat TFESIs within 3 months of the index injection can provide cumulative benefit. Friedly et al (2014) reported that rigorous data are lacking regarding the effectiveness and safety of epidural glucocorticoid injections for the treatment of lumbar spinal stenosis. In a double-blind, multisite trial, the authors randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-tosevere leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland-Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine"). At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group, -1.0 points; 95% confidence interval [CI], -2.1 to 0.1; P=0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, -0.2 points; 95% CI, -0.8 to 0.4; P=0.48). A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks. The authors concluded in the treatment of lumbar spinal Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 9

10 stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. van Helvoirt et al (2014) reported on the clinical course of patients with MRIconfirmed lumbar disc herniation-related radicular noncentralizing pain who received transforaminal epidural steroid injections (TESIs) and mechanical diagnosis and mechanical diagnosis and therapy (MDT) in a prospective cohort study. Consecutive candidates for herniated lumbar disc surgery with noncentralizing chronic pain were eligible. Patients received TESIs followed by MDT. The primary outcomes were pain severity in the leg, disability (Roland-Morris Disability Questionnaire for Sciatica), and global perceived effect (GPE). Outcomes were measured at baseline, discharge, and 12 months. Linear mixed-models and McNemar's tests were used to analyze outcome data. Sixty-nine patients receive TESIs. After TESIs, symptoms were resolved completely in 11 patients (16%). In these patients, symptom resolution was maintained at 12 months. A second subgroup of 32 patients (46%) reported significantly less pain after TESIs and showed centralization with MDT reassessment (significant reductions in leg pain and disability [P<0.001]) and a satisfaction rate of 90% at 12 months. A third subgroup of 11 patients (16%) reported significantly less pain after TESIs but still showed noncentralization with MDT reassessment (significant reductions in leg pain and disability [P<0.05] and a satisfaction rate of 50% at 12 months). A fourth subgroup of 15 patients (22%) did not respond on TESIs and received an operative intervention. The authors concluded the results indicate that a course of TESIs followed by MDT may be able to avoid surgery in a substantial proportion of candidates for herniated lumbar disc surgery. Kraiwattanapong et al (2014) reported the short and long term outcomes of fluoroscopically guided lumbar TFESI in degenerative lumbar spondylolisthesis (DLS) patients in a prospective cohort study. The DLS patients received fluoroscopically guided lumbar TFESI with 80 mg of methylprednisolone and 2 ml of 1% lidocaine hydrochloride. Patients were evaluated by an independent observer before the initial injection, at 2 weeks, at 6 weeks, at 3 months, and at 12 months after the injections. Visual analog scale (VAS), Roland 5-point pain scale, standing tolerance, walking tolerance, and patient satisfaction scale were evaluated for outcomes. Thirty three DLS patients treated with TFESI, who were completely followed up, were included in this study. The average number of injections per patient was 1.9 (range from 1 to 3 injections per patient). Significant improvements in VAS and Roland 5- point pain scale were observed over the follow up period from 2 weeks to 12 months. However, the standing and walking tolerance were not significantly improved after 2 weeks. At 2 weeks, the patient satisfaction scale was highest, although, these outcomes declined with time. The DLS patients with one level of spinal stenosis showed significantly better outcome than the DLS patients with two levels of spinal stenosis. Five patients (13%) underwent surgical treatment during the 3 to 12 months follow up. The authors concluded TFESI provides short term improvements in VAS and Roland 5-point pain scale, standing tolerance, walking tolerance and patient satisfaction scale in DLS patients. In the long term, it improves VAS but limits the improvements in Roland 5-point pain scale, standing tolerance, walking tolerance and patient satisfaction scale. Lee et al (2014) analyzed the effectiveness of fluoroscopic cervical paramidline interlaminar epidural steroid injection (ESI) as well as to assess outcome predictors. One hundred forty-three patients (M:F = 89:54, mean age = 53.1 years old) who received cervical paramidline interlaminar ESIs in 2011 were included in this study. Initial improvements at 2 weeks were assessed. For possible outcome predictors, Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 10

11 clinical and MR variables were statistically analyzed using the Mann-Whitney U, Chisquare, and Fisher's exact tests. Initial improvements after cervical paramidline interlaminar ESIs at 2 weeks were reported in 115 of 143 patients (80.8%). Patients with paresthesia only and no pain showed significantly fewer improvements after ESIs (11/19, 57.9%) than patients with pain (104/124, 83.9%) (p = 0.013). Other variables were not statistically significant outcome predictors. The authors concluded fluoroscopic paramidline interlaminar cervical ESIs effectively managed cervical radiculopathy, irrespective of the cause or zone of nerve root compression, and patients with paresthesia only experienced fewer improvements. Manchikanti et al (2014) assessed the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 ml), whereas Group II patients received 0.5% lidocaine, 4 ml, mixed with 1 ml or 6 mg of nonparticulate betamethasone. The primary outcome measure was 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. Significant pain relief and functional improvement ( 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up. The investigators concluded cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain. Manchikanti et al (2014) assessed the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis in a randomized, double-blind, active-controlled trial with 2-year follow-up. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone. The primary outcome measure was defined as pain relief and functional status improvement of 50%. The outcomes were assessed by numeric rating scale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondary outcome measures included employment status and opioid intake. Results showed significant improvement in 60% of patients in Group I and 70% of patients in Group II at the end of 2 years. In addition, in the successful groups, those with at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% in Group I and 71% in Group II. Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group. Thus, the results indicate that a patient's failure to respond to local anesthetic alone, may be treated with addition of steroids. The results of the study are limited by the lack of a placebo group. The authors concluded lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality, in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities. Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 11

12 Scientific Rationale Update October 2012 Manchikanti et al (2012) evaluated the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis in a randomized, double-blind, active controlled trial. One-hundred twenty patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 ml); Group II patients received 0.5% lidocaine, 4 ml, mixed with 1 ml of nonparticulate betamethasone. Primary outcome measure was 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight. Significant pain relief and functional status improvement ( 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group. Investigators concluded cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis. In another randomized, controlled, double blind, active control trial, Manchikanti et al (2012) assessed the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. One hundred twenty patients were randomized to two groups: Group I received 10 ml caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 ml, mixed with 1 ml of steroid. Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. In the successful category, 77% of Group I had significant pain relief of > 50% and functional status improvement of > 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Presumed limitations of this evaluation include lack of a placebo group. Investigators concluded caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. Another randomized, double-blind, active-controlled trial reported by Manchikanti et al (2012), evaluated the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief in the management of chronic low back pain related to lumbar spinal stenosis. One-hundred participants were randomly assigned to 1 of the 2 groups, with Group I participants receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II participants received caudal epidural injections with 0.5% lidocaine 9 ml mixed with 1 ml of steroid (nonparticulate Celestone). Multiple outcome measures were used, including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 12

13 posttreatment. Significant pain relief and improvement in disability were defined as 50% or more. Overall, significant pain relief and functional status improvement ( 50%) were demonstrated in 48% in Group I and 46% in Group II. However, significant pain relief and functional status improvement were seen in 60% of the participants in both groups in the successful category when the participants were separated into successful and failed categories. The overall number of procedures was 3.1±1.3 or 3.6±1.1 in the successful category in Group I, with overall 2.9±1.4 or 3.5±1.2 in the successful category in Group II. Investigators concluded caudal epidural injections of local anesthetic with or without steroids may be an effective treatment for a select group of patients with chronic function-limiting low back and lower extremity pain secondary to spinal stenosis. Manchikanti et al (2012) evaluated the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with upper extremity pain in patients with cervical central spinal stenosis in a randomized, double-blind, active control trial. Patients with cervical central spinal stenosis were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Sixty patients were included in this analysis. Randomization was performed by computergenerated random allocation sequence by simple randomization. Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction of NRS or NDI scores. Significant pain relief was seen in 73% in Group I and 70% in Group II, in Group II showing both significat pain releif and functional status improvements. Group I's average relief per procedures was 11.3 ± 5.8 weeks; for Group II it was 8.6 ± 3.6 weeks, whereas after initial 2 procedures, average relief was 13.7 ± 8.7 weeks in Group I, and 13.6 ± 4.7 weeks in Group II. In the successful group, the average total relief in a one-year period was 42.2 ± 14.7 weeks in Group I and 34.3 ± 13.4 weeks in Group II, with 76% in Group I and 77% in Group II. Study limitations include the lack of a placebo group and that this is a preliminary report of only 60 patients, 30 in each group. Investigators concluded patients who have chronic function-limiting pain that is secondary to cervical central stenosis might receive relief with cervical interlaminar epidurals of local anesthetic, whether with or without steroids. Mobaleghi et al (2012) compared long-term effects of epidural steroid injections (ESI) in herniated disks (HD) and lumbar spinal stenosis (LSS) patients in a prospective, single-blind uncontrolled study, 60 patients with radicular pain due to HD (n = 32) or LSS (n = 28) were enrolled over a 9-month period. Methylprednisolone acetate 80 mg plus 0.5% bupivacaine 10 mg were diluted in normal saline up to a total volume of 10 ml, and injected into the epidural space. The amount of pain based on numeric pain score, level of activity, and subjective improvement were reported by patients after 2 and 6 months by telephone. Demographic data were analyzed with the chi-square test. The differences in numeric pain scale scores between the two groups at different times were analyzed with the t-test. There were no differences between HD and LSS patients regarding age, sex, and average duration of pain prior to ESI. The degree of pain was significantly higher in LSS patients in comparison with HD patients in the preinjection period. The amount of pain was significantly reduced in both groups 2 months after injection. This pain reduction period lasted for 6 months in the HD group, but to a lesser extent in LSS patients (P < 0.05). Investigators concluded Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 13

14 epidural methylprednisolone injection has less analgesic effect in LSS, with less permanent effect in comparison with HD. Scientific Rationale October 2011 Evidence from randomized controlled or comparative trials, meta-analyses, and systematic reviews suggest that epidural steroid injection can produce a transient improvement in symptoms of low back pain and sciatica caused by a herniated disc or spinal stenosis, when conservative therapy has failed. The goals of epidural steroid injection are to provide relief of pain, improve function, and delay or avoid surgery. The North American Spine Society (NASS) guidelines on the diagnosis and treatment of degenerative lumbar spinal stenosis (2007) states: Nonfluoroscopically-guided interlaminar epidural steroid injections can result in short term (two to three weeks) symptom relief in patients with neurogenic claudication or radiculopathy. There is, however, conflicting evidence concerning long-term efficacy. The NASS notes further, A single radiographically-guided transforaminal epidural steroid injection can produce short term relief in patients with radiculopathy from lumbar spinal stenosis. There is, however, conflicting evidence concerning the long-term efficacy of a single injection. Both recommendations are a B rating. According to 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 (2010). Epidural steroid injections with or without local anesthetics may be used as part of a multimodal treatment regimen to provide pain relief in selected patients with radicular pain or radiculopathy. Shared decision making regarding epidural steroid injections should include a specific discussion of potential complications, particularly with regard to the transforaminal approach. Transforaminal epidural injections should be performed with appropriate image guidance to confirm correct needle position and spread of contrast before injecting a therapeutic substance; image guidance may be considered for interlaminar epidural injections. Kovacs et al (2011) performed a systematic review comparing the effectiveness of surgery vs. conservative treatment on pain, disability and loss of quality of life caused by symptomatic lumbar spinal stenosis (LSS). Randomized controlled trials (RCTs) comparing any form of conservative and surgical treatment were searched for review until July Additional data were requested from the authors of the original studies. The methodological quality of each study was assessed independently by two reviewers, following the criteria recommended by the Cochrane Back Review Group. Only data from randomized cohorts were extracted.results: 739 citations were reviewed. Eleven publications corresponding to five RCTs were included. All five scored as high quality, despite concerns deriving from heterogeneity of treatment, lack of blinding and potential differences in the size of the placebo effect across groups. They included a total of 918 patients in whom conservative treatments had failed for 3-6 months, and included orthosis, rehabilitation, physical therapy, exercise, heat and cold, TENS, ultrasounds, analgesics, non steroidal anti-inflammatory drugs and epidural steroids. Surgical treatments included the implantation of a specific type of interspinous device and decompressive surgery (with and without fusion, instrumented or not). In all the studies, surgery showed better results for pain, disability and quality of life, although not for walking ability. Results of surgery were similar among patients with and Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 14

15 without spondylolisthesis, and slightly better among those with neurogenic claudication than among those without it.the advantage of surgery was noticeable at 3-6 months and remained for up to 2-4 years, although at the end of that period differences tended to be smaller. The reviewers concluded in patients with symptomatic LSS, the implantation of a specific type of device or decompressive surgery, with or without fusion, are more effective than continued conservative treatment when the latter has failed for 3-6 months. Briggs et al (2010) quantified the effectiveness of injection treatment on pain relief among adults 60 years and over who were diagnosed with degenerative lumbar spinal stenosis, a common cause of lower back pain in older adults. The variations of the effectiveness were examined by selected patient attributes. The study design was a prospective, non-randomized, observational single center study. Patients scheduled for lumbar injection treatment between January 1 and July 1, 2008 were prospectively selected. Selection criteria included patients age 60 and over, diagnosed with degenerative lumbar spinal stenosis and no previous lumbar injection within 6 months or lumbar surgery within 2 years. The pain sub-score of the SF-36 questionnaire was used to measure pain at baseline and at one and 3 months post injection. Variations in longitudinal changes in pain scores by patient characteristics were analyzed in both unadjusted (univariate) analyses using one-way analysis of variance (ANOVA), and adjusted (multiple regression) analyses using linear mixed effects models. Of 62 patients receiving epidural steroid injections, the mean Pain score at baseline was 27.4 (SD =13.6), 41.7 (SD = 22.0) at one month and 35.8 (SD = 19.0) at 3 months. Mean Pain scores improved significantly from baseline to one month (14.1 points), and from baseline to 3 months (8.3 points). Post injection changes in pain scores varied by body mass index (BMI) and baseline emotional health. Based on a linear mixed effects model analysis, higher baseline emotional health, as measured by the SF-36 Mental Component Score (MCS > 50), was associated with greater reduction in pain over 3 months when compared to lower emotional health (MCS), was associated with greater reduction in pain over 3 months when compared to lower emotional health (MCS <50). In patients with higher emotional health, pain scores improved by Patients who were obese also showed significant improvement in pain scores over 3 months compared to nonobese patients. In obese patients, pain scores increased by 7.9 points. Lee et al (2010) evaluated the short-term and long-term effects of fluoroscopically guided caudal epidural steroid injection (ESI) for the management of degenerative lumbar spinal stenosis (DLSS) and to analyze outcome predictors. Patients who underwent caudal ESI in 2006 for DLSS were included in the study. Response was based on chart documentation (aggravated, no change, slightly improved, much improved, no pain). In June 2009 telephone interviews were conducted, using formatted questions including the North American Spine Society (NASS) patient satisfaction scale. For short-term and long-term effects, age difference was evaluated by the Mann-Whitney U test, and gender, duration of symptoms, level of DLSS, spondylolisthesis, and previous operations were evaluated by Fisher's exact test. Two hundred and sixteen patients (male:female = 75:141; mean age 69.2 years; range 48 approximately 91 years) were included in the study. Improvements (slightly improved, much improved, no pain) were seen in 185 patients (85.6%) after an initial caudal ESI and in 189 patients (87.5%) after a series of caudal ESIs. Half of the patients (89/179, 49.8%) replied positively to the NASS patient satisfaction scale (1 or 2). There were no significant outcome predictors for either the short-term or the long-term responses. Investigators concluded fluoroscopically Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 15

16 guided caudal ESI was effective for the management of DLSS (especially central canal stenosis) with excellent short-term and good long-term results, without significant outcome predictors. Kabatas et al (2010) analyzed the data of 40 patients (February 2008 and April 2009) with the diagnosis of chronic low back pain (CLBP) and treated by fluoroscopically guided of fluoroscopically guided transforaminal epidural steroid injections (TFESIs) via a preganglionic approach. Patients were followed-up at one month (short term), six months (midterm) and one year (long term) after injections. Follow-up data collection included the Visual Numeric Pain Scale (VNS) and North American Spine Society (NASS) patient satisfaction scores. The mean age of the patients was / years (range years, 25 women). Average follow-up period was / months. Statistically significant differences were observed between the pre-procedure and post-procedure VNSs. Improvements in VNS scores were correlated with improvements in the NASS scores. When the VNS scores were evaluated with respect to the age of patient, level numbers, gender, pre-procedure symptom duration and pre-procedure VNS, no significant differences were found. At short term evaluation in post treatment (one month), % of patients were found to have a successful outcome and % were deemed failures. Overall patient satisfaction was % in the midterm period. Additionally, % of patients (N/n: 15/8) had a successful long-term outcome at a follow-up of one year. The authors concluded the data suggest that fluoroscopically guided TFESIs via a preganglionic approach, in patients with foraminal stenosis due to lumbar spinal stenosis and lumbar discogenic pain with radiculopathy, has effective outcome and patients responding to injection have significantly lower post-injection pain scores. Tran de QH et al (2010) summarized the evidence derived from randomized controlled trials pertaining to the nonsurgical treatment of lumbar spinal stenosis (LSS). Only RCTs pertaining to nonsurgical treatment were considered. Studies comparing conservative and surgical management or different surgical techniques were not included in the review. The search yielded 13 RCTs. The average enrolment was 54 subjects per study. Blinded assessment and sample size justification were provided in 85% and 39% of RCTs, respectively. The available evidence suggests that parenteral calcitonin, but not intranasal calcitonin, can transiently decrease pain in patients with LSS. In the setting of epidural blocks, local anesthetics can improve pain and function, but the benefits seem short-lived. The available evidence does not support the addition of steroids to local anesthetic agents. Based on the limited evidence, passive physical therapy seems to provide minimal benefits in LSS. The optimal regimen for active physiotherapy remains unknown. Although benefits have been reported with gabapentin, limaprost, methylcobalamin, and epidural adhesiolysis, further trials are required to validate these findings. The reviewers concluded because of their variable quality, published RCTs can provide only limited evidence to formulate recommendations pertaining to the nonsurgical treatment of LSS. In this narrative review, no study was excluded based on factors such as sample size justification, statistical power, blinding, definition of intervention allocation, or clinical outcomes. This aspect may represent a limitation as it may serve to overemphasize evidence derived from "weaker" trials. Further well-designed RCTs are warranted. Koc et al (2009) aimed to compare the effects of epidural steroid injections and physical therapy program on pain and function in patients with lumbar spinal Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 16

17 stenosis (LSS). A total of 29 patients diagnosed as LSS were randomized into 3 groups. Group 1 (n = 10) received an inpatient physical therapy program for 2 weeks, group 2 (n = 10) received epidural steroid injections, and group 3 (n = 9) served as the controls. All study patients additionally received diclofenac and a home-based exercise program. The patients were evaluated at baseline, 2 weeks, 1 month, 3 months, and 6 months after treatment by finger floor distance, treadmill walk test, sit-to-stand test, weight carrying test, Roland Morris Disability Index, and Nottingham Health Profile. Both epidural steroid and physical therapy groups demonstrated significant improvement in pain and functional parameters and no significant difference was noted between the 2 treatment groups. Significant improvements were also noted in the control group. Pain and functional assessment scores (RMDI, NHP physical activity subscore) were significantly more improved in group 2 compared with controls at the second week. Investigators concluded epidural steroid injections and physical therapy both seem to be effective in LSS patients up to 6 months of follow-up. Scientific Rationale Update January 2011 Epidural steroid injections (ESIs) have been endorsed by the North American Spine Society and the Agency for Healthcare Research and Quality (formerly, the Agency for Health Care Policy and Research) of the Department of Health and Human Services as an integral part of nonsurgical management of radicular pain from lumbar spine disorders. Clinical manifestations of nerve root inflammation include some or all of the following: radicular pain, dermatomal hypesthesia, weakness of muscle groups innervated by the involved nerve root(s), diminished deep tendon reflexes, and positive straight or reverse leg raising tests. In contrast to oral steroids, ESIs offer the advantage of a more localized medication delivery to the area of affected nerve roots, thereby decreasing the likelihood of potential systemic side effects. Studies have indicated that ESIs are most effective in the presence of acute nerve root inflammation. Buenaventura et al. (2009) completed a systematic review on lumbar transforaminal epidural injection confirmed its efficacy. Evidence drawn from well-designed controlled trials without randomization indicated that transforaminal ESIs can provide short-term (<6 months) relief of radicular low back pain. Evidence obtained from well-designed cohort or case-control analytic studies also suggested long term (>6 months) benefit. Conn et al. (2009) completed a systematic review of caudal epidural injections with or without steroids in managing chronic pain secondary to lumbar disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and discogenic pain without disc herniation or radiculitis. The objective of this study was to evaluate the effect of caudal epidural injections with or without steroids in managing various types of chronic low back and lower extremity pain emanating as a result of disc herniation or radiculitis, post-lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain. A review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). The primary outcome measure was pain relief (short- Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 17

18 term relief = up to 6 months and long-term > or = 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. The evidence showed Level I for shortand long-term relief in managing chronic low back and lower extremity pain secondary to lumbar disc herniation and/or radiculitis and discogenic pain without disc herniation or radiculitis. The indicated evidence is Level II-1 or II-2 for caudal epidural injections in managing low back pain of post-lumbar laminectomy syndrome and spinal stenosis. The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation. This systematic review shows Level I evidence for relief of chronic pain secondary to disc herniation or radiculitis and discogenic pain without disc herniation or radiculitis. Further, the indicated evidence is Level II-1 or II-2 for caudal epidural injections in managing chronic pain of post lumbar laminectomy syndrome and spinal stenosis. Scientific Rationale - Update August 2007 According to the American Society of Interventional Pain Physicians 2007 guidelines Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain, the evidence of interlaminar epidural steroid injections in managing lumbar radiculopathy is strong for short-term relief and limited for longterm relief. In managing cervical radiculopathy, the evidence is moderate for shortterm and long-term relief. The evidence is indeterminate in the management of neck pain, low back pain, and lumbar spinal stenosis. The evidence is indeterminate in the management of axial neck pain, axial low back pain, post-lumbar laminectomy syndrome, and lumbar spinal stenosis. Abdi et al (2007) conducted a systematic review of randomized and non-randomized trials to determine the effectiveness of epidural injections. The primary outcome measure was pain relief. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Short-term improvement was defined as 6 weeks or less, and long-term relief was defined as 6 weeks or longer. The authors found that in managing lumbar radicular pain with interlaminar lumbar epidural steroid injections, the evidence is strong for short-term relief and limited for long-term relief. In managing cervical radiculopathy with cervical interlaminar epidural steroid injections, the evidence is moderate. The evidence for lumbar transforaminal epidural steroid injections in managing lumbar radicular pain is strong for short-term and moderate for long-term relief. The evidence for cervical transforaminal epidural steroid injections in managing cervical nerve root pain is moderate. The evidence is moderate in managing lumbar radicular pain in post lumbar laminectomy syndrome. The evidence for caudal epidural steroid injections is strong for short-term relief and moderate for long-term relief, in managing chronic pain of lumbar radiculopathy and postlumbar laminectomy syndrome. They concluded that there is moderate evidence for interlaminar epidurals in the cervical spine and limited evidence in the lumbar spine for long-term relief. The evidence for cervical and lumbar transforaminal epidural steroid injections is moderate for longterm improvement in managing nerve root pain. The evidence for caudal epidural steroid injections is moderate for long-term relief in managing nerve root pain and chronic low back pain. Boswell et al (2003) also performed a systematic review of epidural steroids in the management of chronic spinal pain and radiculopathy. Data sources included relevant literature of both randomized and non-randomized studies identified through searches of MEDLINE, EMBASE (Jan Mar 2003), manual searches of Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 18

19 bibliographies of known primary and review articles, and abstracts from scientific meetings. The results showed that there was strong evidence to indicate effectiveness of transforaminal epidural injections in managing lumbar nerve root pain. Further, evidence was moderate for caudal epidural injections in managing lumbar radicular pain. The evidence in management of chronic neck pain, chronic low back pain, cervical radiculopathy, spinal stenosis, and post laminectomy syndrome was limited or inconclusive. In conclusion, the evidence of effectiveness of transforaminal epidural injections in managing lumbar nerve root pain was strong, whereas, effectiveness of caudal epidural injections in managing lumbar radiculopathy was moderate, while there was limited or inconclusive evidence of effectiveness of epidural injections in managing chronic spinal pain without radiculopathy, spinal stenosis, post lumbar laminectomy syndrome, and cervical radiculopathy. In summary, it appears that the epidural administration of corticosteroids is a potentially valuable treatment technique in the management of some patients with radicular pain of recent onset. Scientific Rationale - Update June 2005 Epidural steroid injections still continue to have a significant role in the treatment of patients with low back, neck, and radicular pain. Although these procedures may not address the causative lesions, they often shorten the clinical course of the disease process, keep patients out of the hospital, and provide symptomatic relief that improves quality of life. These procedures are most accurately performed with fluoroscopic guidance and major complications are rare. Although support for cervical epidural steroid injection is less uniform than that for lumbar and caudal injections, a growing body of experience is beginning to support its efficacy and safety. Significant and lasting pain relief can be achieved with transforaminal epidural steroid injection. Surgery is indicated for those patients with progressive neurological deficits or severe LRP refractory to conservative measures. One prospective randomized study of the therapeutic effect of intradiscal steroid injection compared to a saline placebo was performed to determine whether intradiscal steroid injection influences the clinical outcome at 1 year in patients with chronic low back pain of discogenic origin. The authors concluded that intradiscal steroid injections do not improve the clinical outcome in patients with discogenic back pain compared with placebo. One study compared epidural steroid injection with discectomy in the treatment of patients with a large, symptomatic lumbar herniated nucleus pulposus who are surgical candidates. The searchers found that epidural steroid injection was not as effective as discectomy with regard to reducing symptoms and disability associated with a large herniation of the lumbar disc. However, epidural steroid injection did have a role: it was found to be effective for up to three years by nearly one-half of the patients who had not had improvement with six or more weeks of noninvasive care. Another study was carried out to evaluate the effectiveness of epidural steroid injections for patients with symptomatic lumbar disc herniations who were surgical candidates found that epidural steroid injections have a reasonable success rate for the alleviation of radicular symptoms from lumbar herniated discs for up to twelve to twenty-seven months. Patients treated with injections may be able to avoid surgical treatment up to this period and perhaps even longer. Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 19

20 No conclusive evidence exists to determine that spinal steroid injections give lasting improvement in patients with predominantly axial low back pain resulting from lumbar degenerative disc disease (DDD). One study concluded that spinal steroid injections are beneficial for a small number of patients with advanced DDD and chronic low back pain. For those patients in whom a beneficial effect is found, spinal steroid injection is a low-risk and rapid treatment option. Spinal steroid injections are more effective in patients with MRI findings of discogenic inflammation, specifically adjacent inflammatory end-plate changes. Scientific Rationale - Initial The scientific literature does not reveal a consensus of definition for acute and chronic low back pain. However, most define acute low back pain as pain that resolves during the expected healing time of an injury or illness, usually considered to be 6 months or less. Chronic low back pain is pain that persists beyond the expected healing time of an injury or illness, usually considered to be beyond 6 months. It is also recognized that acute exacerbations or new acute episodes may be superimposed on otherwise chronic conditions. Epidural steroid injections for low back pain are the most commonly used therapeutic procedures in pain management clinics. Their purpose is to achieve relief from nerve root irritation (i.e., radicular pain or sciatica) related to encroachment by a disk herniation, bone spur or scar tissue, or by various causes of neuritis (e.g., radiation, chemical or autoimmune). This causes the nerve to become irritated, inflamed, and swollen. Steroids are powerful anti-inflammatory agents and act to decrease the swelling and inflammation in the nerve, thereby breaking the cycle of swelling and irritation. An epidural injection involves placing a small needle into the cervical, lumbar or caudal area of the spine and injecting a mixture of a local anesthetic and a steroid solution into the space surrounding the dural membrane near the site where the nerve roots pass before entering the intervertebral foramen. Specialized needles such as a Touhy, Huber, or Weiss, etc. or a catheter placed in the epidural space is utilized. The procedure is usually performed in the outpatient setting under fluoroscopic control so as to increase the accuracy of the needle placement and decrease the possibility of dural puncture. The theory is that injecting medication into the epidural space allows a concentrated amount of medication to be deposited and retained in a specific area, exposing the nerves to the medication for a prolonged period of time. The therapeutic objective of epidural injections is to reduce swelling, inflammation and pain. The corticosteroid injected may remain for several weeks. It is usually not necessary to repeat an injection if there has been satisfactory response to the first injection. Should there not be a satisfactory response to the first injection, then the interval between injections must be at least one week. Predictors of a clinically meaningful response include the presence of nerve root irritation or compression, the presence of radicular pain and radicular numbness, short duration of symptoms (pain < 6 months), and the absence of psychological overlay in patients with herniated disks. Physical and laboratory examination findings that are positive predictors include the presence of dermatomal sensory loss, motor weakness correlating with the involved nerve root, positive straight leg raising, abnormality on the electromyogram (EMG) involving the affected nerve root, and the documentation of a herniated disk on MRI imaging. Other factors include the absence Epidural Steroid Injections: Treatment of Low Back and Cervical Pain Oct 15 20

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