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The Role of Fluoroscopic Interlaminar Epidural Injections in Managing Chronic Pain of Lumbar Disc Herniation or Radiculitis: A Randomized, Double-Blind Trial.

Journal Pain practice : the official journal of World Institute of Pain
Year 2013
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This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background There is continued debate on the effectiveness, indications, and medical necessity of epidural injections in managing pain and disability from lumbar disc herniation, despite extensive utilization. There is paucity of literature on interlaminar epidural injections in managing lumbar disc herniation or radiculitis in contemporary interventional pain management settings utilizing fluoroscopy. Methods A randomized, double-blind, active-control trial was undertaken to assess the effectiveness of lumbar interlaminar epidural injections with or without steroids for disc herniation and radiculitis. The primary outcome was defined as pain relief and functional status improvement of ≥ 50%. One hundred twenty patients were randomly assigned to 1 of the 2 groups. Group I patients received lumbar interlaminar injections containing a local anesthetic (lidocaine 0.5%, 6 mL), whereas Group II patients received lumbar interlaminar epidural injections of 0.5% lidocaine, 5 mL, mixed with 1 mL of non-particulate betamethasone. Results In the patients who responded with initial 2 procedures with at least 3 weeks of relief, significant improvement was seen in 80% of the patients in the local anesthetic group and 86% of the patients in the local anesthetic and steroid group. The overall average procedures per year were 3.6 in the local anesthetic group and 4.1 in the local anesthetic and steroid group, with an average relief of 33.7 ± 18.1 weeks in the local anesthetic group and 39.1 ± 12.2 weeks in the local anesthetic and steroid group over a period of 52 weeks in the overall population. Conclusions Lumbar interlaminar epidural injections of local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis, with potential superiority of steroids compared with local anesthetic alone at 1 year follow-up.

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Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain

Journal Journal of pain research
Year 2012
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source. © 2012 Manchikanti et al, publisher and licensee Dove Medical Press Ltd.

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Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial.

Journal Pain physician
Year 2012
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This article is included in 4 Systematic reviews Systematic reviews (4 references) 2 Broad syntheses Broad syntheses (2 references)

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BACKGROUND: Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied. STUDY DESIGN: A randomized, double-blind, active, control trial. SETTING: A private, interventional pain management practice, specialty referral center in the United States. OBJECTIVE: This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids. METHODS: The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed. OUTCOMES ASSESSMENT: Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of  >/= 50% was considered significant. RESULTS: Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I's significant pain relief was 70%; Group II's was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain relief and functional status improvement were seen in 80% of patients in Group I and 72% in Group II in successful group. LIMITATIONS: The lack of a placebo group and preliminary results are limitations. CONCLUSION: Patients might benefit from receiving lumbar interlaminar injections with or without steroids for lumbar central spinal stenosis. CLINICAL TRIAL: NCT00681447.

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Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial.

Journal Annals of internal medicine
Year 2012
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This article is included in 7 Systematic reviews Systematic reviews (7 references)

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BACKGROUND: Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy. OBJECTIVE: To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy. DESIGN: A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096) SETTING: Military and civilian treatment centers. PATIENTS: 84 adults with lumbosacral radiculopathy of less than 6 months' duration. INTERVENTION: 2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks. MEASUREMENTS: The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period. RESULTS: The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI,-2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept (42%) (P = 0.09). LIMITATION: Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept. CONCLUSION: Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits. PRIMARY FUNDING SOURCE: The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.

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Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up.

Journal Pain physician
Year 2012
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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<b>BACKGROUND: </b>Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used.<b>STUDY DESIGN: </b>A randomized, controlled, double blind, active control trial.<b>SETTING: </b>A private, interventional pain management practice, specialty referral center in the United States.<b>OBJECTIVES: </b>To assess 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.<b>METHODS: </b>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.<b>Outcome Assessment: </b>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.<b>RESULTS: </b>In the successful category, 77% of Group I had significant pain relief of &gt;/= 50% and functional status improvement of &gt;/= 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.<b>Limitations: </b>Presumed limitations of this evaluation include lack of a placebo group.<b>CONCLUSION: </b>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.<b>Trial Registration: </b>NCT00370799.

Primary study

Unclassified

Interlaminar versus transforaminal epidural steroids for the treatment of subacute lumbar radicular pain: a randomized, blinded, prospective outcome study.

Journal Pain physician
Year 2011
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This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: There is uncertainty in the literature over the relative effectiveness of lumbar epidural interlaminar (IL) steroid injection versus transforaminal (TF) steroid injection for lumbar radiculopathy. Most studies to date have been retrospective, or technically focused. OBJECTIVE: To complete a randomized, blinded, prospective outcome study of the short-term benefit for IL versus TF epidural steroids for the treatment of subacute lumbar radicular pain. STUDY DESIGN: Prospective, randomized, blinded, subacute efficacy trial. SETTING: Tertiary care pain management center, major metropolitan city, United States. METHODS: After institutional review board approval, 42 age-matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a patient and evaluating physician blinded trial to IL or TF epidural steroids from 2007 through 2009. Prior to intervention and 10-16 days after injection, each participant was evaluated by questionnaire and physical exam by an independent physician. All injections were performed by the same physician. Thirty-eight participants completed the study, 18 in the IL group and 20 in the TF group. Four participants required a repeat injection, and 2 participants crossed over to the alternative injection type (IL to TF). RESULTS: Overall, physical exam, diagnostic testing, disability, activity, depression measures, and opioid pill use were similar between the 2 groups, both pre-injection baseline and post-injection improvement. In primary outcomes, the post-injection follow-up Numeric Rating Scale (NRS) was more greatly reduced in the TF group. The NRS decreased from 7.0 ± 1.9 to 3.9 ± 3.1 (mean values +/- standard deviation) in the IL group and 6.4 ± 2.1 to 1.7 ± 1.4 in the TF group. The Oswestry Disability Index was reduced from 37.5 ± 12.6 to 19.0 ± 16.7 in the IL group and 38.3 ± 6.4 to 21.6 ± 16.8 in the TF group. In secondary outcomes, the depression scale was reduced from 4.39 ± 3.22 to 2.28 ± 3.20 in the IL group and 4.10 ± 1.94 to 1.65 ± 1.63 in the TF group. Walking tolerance was increased from 8.1 ± 4.6 blocks to 10.6 ± 4.4 in the IL group and 8.9 ± 5.3 blocks to 11.8 ± 4.2 in the TF group. LIMITATIONS: The study did not examine long-term outcomes. A single experienced interventionalist performed all injections. CONCLUSION: Results suggest that patients may experience greater subjective relief, at least initially, from TF epidural steroid injections over IL. However, more objective, and likely subacute, therapeutic effects are similar.

Primary study

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Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial.

Journal BMJ (Clinical research ed.)
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 5 Systematic reviews Systematic reviews (5 references)

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OBJECTIVE: To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks). DESIGN: Multicentre, blinded, randomised controlled trial. SETTING: Outpatient multidisciplinary back clinics of five Norwegian hospitals. PARTICIPANTS: Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity. INTERVENTIONS: Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval. MAIN OUTCOME MEASURES: Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain. RESULTS: Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n = 40), estimated change in the Oswestry disability index from the adjusted baseline value was -4.7 (95% confidence intervals -0.6 to -8.8) at 6 weeks, -11.4 (-6.3 to -14.5) at 12 weeks, and -14.3 (-10.0 to -18.7) at 52 weeks. For the epidural saline intervention group (n = 39) compared with the sham group, differences in primary outcome were -0.5 (-6.3 to 5.4) at 6 weeks, 1.4 (-4.5 to 7.2) at 12 weeks, and -1.9 (-8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were -2.9 (-8.7 to 3.0), 4.0 (-1.9 to 9.9), and 1.9 (-4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend. CONCLUSIONS: Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy. Trial registration Current Controlled Trials ISRCTN No 12574253.

Primary study

Unclassified

Caudal epidural steroid injection: a randomized controlled trial.

Authors Murakibhavi VG , Khemka AG
Journal Evidence-based spine-care journal
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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STUDY DESIGN:  Prospective study. STUDY RATIONALE:  A recurrent phenomenon, the lifetime prevalence of low back pain has been reported as 54%-80%, while annual prevalence ranges from 15%-45%.1 It is also associated with enormous economic, societal, and health impact.2 India, being a developing country, has its problem compounded by the occupational compulsions in parts of the rural areas.3For some interventional therapies, like epidural steroid injections, utilization rates have increased dramatically.4,5,6,7,8,9 They have become one of the most commonly performed interventions in the United States for low back pain with radiculopathy.10CLINICAL QUESTION: Multiple systematic reviews,11 a meta-analysis,12 several guidelines,13 health technology assessments by insurers, and local medical review policies and coverage decisions have been published. However, controversy continues regarding the effectiveness of epidural steroid injections. In addition three types of epidurals, namely interlaminar, transforaminal, and caudal, with variable results complicate the picture for practice of interventional pain management. The underlying mechanism of action of epidurally administered steroid and local anesthetic injections is still not well understood and compounds the problem.14OBJECTIVE: To evaluate and update the effects of caudal epidural injection in the management of chronic low back pain and sciatica.Final Class of evidence-treatmentYes STUDY DESIGN:  RCT• Cohort Case control Case seriesMethods Concealed allocation (RCT)• Intention to treat (RCT)• Blinded/independent evaluation of primary outcome• F/U ≥ 85%• Adequate sample size•Control for confoundingOverall class of evidenceIIThe definiton of the different classes of evidence is available here.

Primary study

Unclassified

Efficacy of interlaminar vs transforaminal epidural steroid injection for the treatment of chronic unilateral radicular pain: prospective, randomized study.

Authors Rados I , Sakic K , Fingler M , Kapural L
Journal Pain medicine (Malden, Mass.)
Year 2011
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This article is included in 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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UNLABELLED: OBJECTIVE, DESIGN AND SETTINGS: The purpose of this randomized, prospective study is to compare the efficacy of two different routes in administering epidural steroid injections interlaminar (IL) vs transforaminal (TF) in patients with unilateral radicular pain. PATIENTS: We randomly enrolled and followed 64 patients with chronic radiculopathy. RESULTS: Significant improvements were maintained throughout 6 months (24 weeks) of follow-up (P<0.001, respectively). The average visual analog scale (VAS) pain scores at 24 weeks improved to 4.0 ± 2.2 cm in the IL group and 3.8 ± 2.1 cm in the TF group (P=0.717). Baseline functional capacity was comparable for the IL and the TF group (52% vs 53%) when assessed using Oswestry (P=0.647). At 6 months, both groups improved, 39% for the IL group and 38% for the TF group, suggesting change from severe to moderate disability scoring range. There were 24 out of the 32 (75%) patients in the IL group at 24 weeks who improved more than 2 cm on the VAS scale and 17 patients (53%) had >50% of the pain relief. In the TF group, there were 27 out of the 32 (84%) patients with >2 cm improvement on VAS pain scale, and 20 of 32 (63%) with >50% improvement at 24 weeks. Functional capacity changes were similar, 16 out of the 32 patients (50%) improved 10 points or more on the Oswestry scale in the IL group and 21 out of the 32 in the TF group (66%). CONCLUSIONS: Using either route of epidural injections to deliver steroids for unilateral chronic radiculopathy secondary to herniated intervertebral disc provided significant improvements in patients function and pain relief. However, we could not find a statistically significant difference between two indicated groups either in functional improvement or in reduction in pain, although half-dose of steroids delivered via TF route provided somewhat better long-term pain relief and functional capacity improvements.

Primary study

Unclassified

A randomized, controlled, double-blind trial of fluoroscopic caudal epidural injections in the treatment of lumbar disc herniation and radiculitis.

Journal Spine
Year 2011
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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STUDY DESIGN.: A randomized, controlled, double-blind trial. OBJECTIVE.: To assess the effectiveness of fluoroscopically directed caudal epidural injections in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis with local anesthetic with or without steroids. SUMMARY OF BACKGROUND DATA.: The available literature on the effectiveness of epidural injections in managing chronic low back pain secondary to disc herniation is highly variable. METHODS.: One hundred twenty patients suffering with low back and lower extremity pain with disc herniation and radiculitis were randomized to one of the two groups: group I received caudal epidural injections with an injection of local anesthetic, lidocaine 0.5%, 10 mL; group II patients received caudal epidural injections with 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid.The Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized with assessment at 3, 6, and 12 months posttreatment. RESULTS.: The percentage of patients with significant pain relief of 50% or greater and/or improvement in functional status with 50% or more reduction in ODI scores was seen in 70% and 67% in group I and 77% and 75% in group II with average procedures per year of 3.8 ± 1.4 in group I and 3.6 + 1.1 in group II. However, the relief with first and second procedures was significantly higher in the steroid group. The number of injections performed was also higher in local anesthetic group even though overall relief was without any significant difference among the groups. There was no difference among the patients receiving steroids. CONCLUSION.: Caudal epidural injection with local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis. The present evidence illustrates potential superiority of steroids compared with local anesthetic at 1-year follow-up.