Systematic reviews including this primary study

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Systematic review

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Journal Clinical orthopaedics and related research
Year 2015
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BACKGROUND: As part of a comprehensive nonsurgical approach, epidural injections often are used in the management of lumbar disc herniation. Recent guidelines and systematic reviews have reached different conclusions about the efficacy of epidural injections in managing lumbar disc herniation. QUESTIONS/PURPOSES: In this systematic review, we determined the efficacy (pain relief and functional improvement) of the three anatomic approaches (caudal, lumbar interlaminar, and transforaminal) for epidural injections in the treatment of disc herniation. METHODS: We performed a literature search from 1966 to June 2013 in PubMed, Cochrane library, US National Guideline Clearinghouse, previous systematic reviews, and cross-references for trials studying all types of epidural injections in managing chronic or chronic and subacute lumbar disc herniation. We wanted only randomized controlled trials (RCTs) (either placebo or active controlled) to be included in our analysis, and 66 studies found in our search fulfilled these criteria. We then assessed the methodologic quality of these 66 studies using the Cochrane review criteria for RCTs. Thirty-nine studies were excluded, leaving 23 RCTs of high and moderate methodologic quality for analysis. Evidence for the efficacy of all three approaches for epidural injection under fluoroscopy was strong for short-term (< 6 months) and moderate for long-term (≥ 6 months) based on the Cochrane rating system with five levels of evidence (best evidence synthesis), with strong evidence denoting consistent findings among multiple high-quality RCTs and moderate evidence denoting consistent findings among multiple low-quality RCTs or one high-quality RCT. The primary outcome measure was pain relief, defined as at least 50% improvement in pain or 3-point improvement in pain scores in at least 50% of the patients. The secondary outcome measure was functional improvement, defined as 50% reduction in disability or 30% reduction in the disability scores. RESULTS: Based on strong evidence for short-term efficacy from multiple high-quality trials and moderate evidence for long-term efficacy from at least one high quality trial, we found that fluoroscopic caudal, lumbar interlaminar, and transforaminal epidural injections were efficacious at managing lumbar disc herniation in terms of pain relief and functional improvement. CONCLUSIONS: The available evidence suggests that epidural injections performed under fluoroscopy by trained physicians offer improvement in pain and function in well-selected patients with lumbar disc herniation.

Systematic review

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Journal The spine journal : official journal of the North American Spine Society
Year 2015
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BACKGROUND: There are numerous treatment approaches for sciatica. Previous systematic reviews have not compared all these strategies together. PURPOSE: To compare the clinical effectiveness of different treatment strategies for sciatica simultaneously. STUDY DESIGN: Systematic review and network meta-analysis. METHODS: We searched 28 electronic databases and online trial registries, along with bibliographies of previous reviews for comparative studies evaluating any intervention to treat sciatica in adults, with outcome data on global effect or pain intensity. Network meta-analysis methods were used to simultaneously compare all treatment strategies and allow indirect comparisons of treatments between studies. The study was funded by the UK National Institute for Health Research Health Technology Assessment program; there are no potential conflict of interests. RESULTS: We identified 122 relevant studies; 90 were randomized controlled trials (RCTs) or quasi-RCTs. Interventions were grouped into 21 treatment strategies. Internal and external validity of included studies was very low. For overall recovery as the outcome, compared with inactive control or conventional care, there was a statistically significant improvement following disc surgery, epidural injections, nonopioid analgesia, manipulation, and acupuncture. Traction, percutaneous discectomy, and exercise therapy were significantly inferior to epidural injections or surgery. For pain as the outcome, epidural injections and biological agents were significantly better than inactive control, but similar findings for disc surgery were not statistically significant. Biological agents were significantly better for pain reduction than bed rest, nonopioids, and opioids. Opioids, education/advice alone, bed rest, and percutaneous discectomy were inferior to most other treatment strategies; although these findings represented large effects, they were statistically equivocal. CONCLUSIONS: For the first time, many different treatment strategies for sciatica have been compared in the same systematic review and meta-analysis. This approach has provided new data to assist shared decision-making. The findings support the effectiveness of nonopioid medication, epidural injections, and disc surgery. They also suggest that spinal manipulation, acupuncture, and experimental treatments, such as anti-inflammatory biological agents, may be considered. The findings do not provide support for the effectiveness of opioid analgesia, bed rest, exercise therapy, education/advice (when used alone), percutaneous discectomy, or traction. The issue of how best to estimate the effectiveness of treatment approaches according to their order within a sequential treatment pathway remains an important challenge.

Systematic review

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Authors Friedman JH , Dighe G
Journal Rhode Island medical journal (2013)
Year 2013
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Epidural steroids recently attracted world attention due to medication contamination resulting in many cases of fungal meningitis. What was rarely noted in these reports is that there is little data to support use of this treatment. This article reviews the literature on epidural steroids for various types of back pain and concludes that further testing should be performed to determine if and in what situations this intervention is useful before wide-spread use is resumed.

Systematic review

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Authors Bicket MC , Gupta A , Brown CH , Cohen SP
Journal Anesthesiology
Year 2013
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BACKGROUND: Epidural steroid injection is the most frequently performed pain procedure. This study of epidural steroid "control" injections aimed to determine whether epidural nonsteroid injections constitute a treatment or true placebo in comparison with nonepidural injections for back and neck pain treatment. METHODS: This systematic review with direct and indirect meta-analyses used PubMed and EMBASE searches from inception through October 2012 without language restrictions. Study selection included randomized controlled trials with a treatment group receiving epidural injections of corticosteroids or another analgesic and study control groups receiving either an epidural injection devoid of treatment drug or a nonepidural injection. Two reviewers independently extracted data including short-term (up to 12 weeks) pain scores and pain outcomes. All reviewers evaluated studies for eligibility and quality. RESULTS: A total of 3,641 patients from 43 studies were included in this systematic review and meta-analysis. Indirect comparisons suggested epidural nonsteroid were more likely than nonepidural injections to achieve positive outcomes (risk ratio, 2.17; 95% CI, 1.87-2.53) and provide greater pain score reduction (mean difference, -0.15; 95% CI, -0.55 to 0.25). In the very limited direct comparisons, no significant differences were noted between epidural nonsteroid and nonepidural injections for either outcome (risk ratio [95% CI], 1.05 [0.88-1.25]; mean difference [95% CI], 0.22 [-0.50 to 0.94]). CONCLUSION: Epidural nonsteroid injections may provide improved benefit compared with nonepidural injections on some measures, though few, low-quality studies directly compared controlled treatments, and only short-term outcomes (<=12 weeks) were examined.

Systematic review

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Journal American journal of physical medicine & rehabilitation / Association of Academic Physiatrists
Year 2012
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OBJECTIVE: The aim of this study was to examine the outcomes related to analgesia, function, mortality, and adverse effects of oral opioid analgesics and spinal steroid injections on low back pain syndromes. DESIGN: Databases including Medline, EMBASE, PubMed, and Cochrane Library were searched in September 2009 using combinations of terms related to spinal pain and its treatment. A systematic review was performed of randomized controlled trials that enrolled patients with low back pain syndromes and that evaluated patient outcomes after intervention using either oral opioids or spinal steroid injections. RESULTS: Eight high-quality and ten moderate-quality randomized controlled trials were identified. One high-quality study on oral opioid therapy showed significant improvements in pain relief and patient function. Those on spinal steroid injections had a decreased Visual Analog Scale pain score by 7.18 (95% confidence interval, 2.21-12.1) points more than the control group at 1 mo or less and by 0.429 (95% confidence interval, -4.41 to 5.27) points at 1-3 mos. At more than 6 mos, there was no significant benefit: 0.930 (95% confidence interval, -5.03 to 6.89). Spinal steroids decreased the Oswestry Disability Index by 3.53 (95% confidence interval, 0.480-6.57) at 1 mo or less, by -0.281 (95% confidence interval, -3.18 to 2.62) at 1-3 mos, by -11.0 (95% confidence interval, -14.8 to -7.16) at 3-6 mos, and by -0.205 (95% confidence interval, -3.50 to 3.09) compared with the control group at 6 mos or more, suggesting that there was improvement in function. All-cause mortality was low in our analysis of patients attending specialty clinics. It was difficult to assess the adverse effects of opioid therapy because they influenced up to 28% of patients to withdraw from the original studies. In terms of spinal steroid injections, headache appeared to be the most common adverse effect. However, there was no significantly increased risk of headaches associated with spinal steroids compared with control injections: odds ratio, 1.29 (95% confidence interval, 0.69-2.39). CONCLUSIONS: Oral opioid therapy may be helpful for the treatment of low back pain, but it is unclear from the high-quality literature whether there are limitations from adverse effects. Spinal steroid injections are beneficial for low back pain and disability in the short-term. The high dropout rates caused by insufficient pain relief and adverse effects suggest that opioids may not be as effective as spinal steroid injections. There is more high-quality literature to support the use of spinal steroid injections compared with oral opioids in this condition.

Systematic review

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Journal Annals of internal medicine
Year 2012
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BACKGROUND: Existing guidelines and systematic reviews provide inconsistent recommendations on epidural corticosteroid injections for sciatica. Key limitations of existing reviews are the inclusion of trials with active controls of unknown efficacy and failure to provide an estimate of the size of the treatment effect. PURPOSE: To determine the efficacy of epidural corticosteroid injections for sciatica compared with placebo. DATA SOURCES: International Pharmaceutical Abstracts, PsycINFO, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and CINAHL. STUDY SELECTION: Randomized, placebo-controlled trials assessing the efficacy of epidural corticosteroid injections in participants with sciatica. DATA EXTRACTION: Two independent reviewers extracted data and assessed risk of bias. Leg pain, back pain, and disability were converted to common scales from 0 (no pain or disability) to 100 (worst possible pain or disability). Thresholds for clinically important change in the range of 10 to 30 have been proposed for these outcomes. Effects were calculated for short-term (>2 weeks but <=3 months) and long-term (>=12 months) follow-up. DATA SYNTHESIS: Data were pooled with a random-effects model, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used in summary conclusions. Twenty-five published reports (23 trials) were included. The pooled results showed a significant, although small, effect of epidural corticosteroid injections compared with placebo for leg pain in the short term (mean difference, -6.2 [95% CI, -9.4 to -3.0]) and also for disability in the short term (mean difference, -3.1 [CI, -5.0 to -1.2]). The long-term pooled effects were smaller and not statistically significant. The overall quality of evidence according to the GRADE classification was rated as high. LIMITATION: The review included only English-language trials and could not incorporate dichotomous outcome measures into the analysis. CONCLUSION: The available evidence suggests that epidural corticosteroid injections offer only short-term relief of leg pain and disability for patients with sciatica. The small size of the treatment effects, however, raises questions about the clinical utility of this procedure in the target population. PRIMARY FUNDING SOURCE: None.

Systematic review

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Journal Pain physician
Year 2012
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BACKGROUND: Intervertebral disc herniation, spinal stenosis, intervertebral disc degeneration without disc herniation, and post lumbar surgery syndrome are the most common diagnoses of chronic persistent low back and lower extremity symptoms, resulting in significant economic, societal, and health care impact. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back pain. However the evidence is highly variable among different techniques utilized - namely interlaminar, caudal, and transforaminal - and for various conditions, namely - intervertebral disc herniation, spinal stenosis, and discogenic pain without disc herniation or radiculitis. Multiple systematic reviews conducted in the evaluation of the effectiveness of interlaminar epidural injections have been marred with controversy. Consequently, the debate continues with regards to the effectiveness, indications, and medical necessity of interlaminar epidural injections. STUDY DESIGN: A systematic review of lumbar interlaminar epidural injections with or without steroids. OBJECTIVE: To evaluate the effect of lumbar interlaminar 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, spinal stenosis, and chronic discogenic pain. METHODS: The available literature on lumbar interlaminar epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, or limited based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: Overall, 82 lumbar interlaminar trials were identified. All non-randomized studies without fluoroscopy and randomized trials not meeting the inclusion criteria were excluded. Overall, 15 randomized trials and 11 non-randomized studies were included in the analysis. Analysis was derived mainly from fluoroscopically-guided randomized trials and non-randomized studies. The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas it is fair for radiculitis secondary to spinal stenosis with local anesthetic and steroids, and fair for axial pain without disc herniation with local anesthetic with or without steroids, with fluoroscopically-guided epidural injections. LIMITATIONS: The limitations of this study include that we were unable to perform meta-analysis for disc herniation, and the paucity of evidence for discogenic pain and spinal stenosis. Further, methodological criteria have been highly variable along with sample sizes. The studies were heterogenous. CONCLUSION: The evidence based on this systematic review is good for lumbar epidural injections under fluoroscopy for radiculitis secondary to disc herniation with local anesthetic and steroids, fair with local anesthetic only; whereas it is fair for radiculitis secondary to spinal stenosis with local anesthetic and steroids, and fair for axial pain without disc herniation with local anesthetic with or without steroids.

Systematic review

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Authors Parr AT , Diwan S , Abdi S
Journal Pain physician
Year 2009
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Background: Low back pain with or without lower extremity pain is the most common problem among chronic pain disorders with significant economic, societal, and health impact. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back pain. However the evidence is highly variable among different techniques utilized - namely interlaminar, caudal, transforaminal - and for various conditions, namely - intervertebral disc herniation, spinal stenosis, and discogenic pain without disc herniation or radiculitis. Study Design: A systematic review of lumbar interlaminar epidural injections with or without steroids. Objective: To evaluate the effect of lumbar interlaminar 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, spinal stenosis, and chronic discogenic pain. Methods: Review of the literature and methodologic quality assessment were 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) for therapeutic interventions. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary and review articles. Results of analysis were performed for multiple conditions separately. Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: The available literature included only blind epidural injections without fluoroscopy. The indicated evidence is positive (Level II-2) for short-term relief of pain of disc herniation or radiculitis utilizing blind interlaminar epidural steroid injections with lacking of evidence with Level III for long-term relief for disc herniation and radiculitis. The evidence is lacking with Level III for short and long-term relief for spinal stenosis and discogenic pain without radiculitis or disc herniation utilizing blind epidural injections. Limitations: The limitations of this study include paucity of literature, lack of quality evidence, lack of fluoroscopic procedures, and lack of applicable evidence in contemporary interventional pain management practices. Conclusion: The evidence based on this systematic review is limited for blind interlaminar epidurals in managing all types of pain except for short-term relief of pain secondary to disc herniation and radiculitis. This evidence does not represent contemporary interventional pain management practices and also the evidence may not be extrapolated to fluoroscopically directed lumbar interlaminar epidural injections.

Systematic review

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Journal The spine journal : official journal of the North American Spine Society
Year 2009
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Background context: Epidural injections are commonly used to treat low back disorders. It has been proposed that in addition to the anti-inflammatory effects, injected material displaces the dura forward and inward, producing a stretch of the nerve roots that leads to lysis of neural adhesions. Despite this, there are no controlled trials investigating the effect of volume injected with pain as an independent outcome. Purpose: Review the existing literature to assess the effect of epidural injection volume on relief of radicular leg and low back pain. Study design: A systematic review of published clinical trials to assess the correlation between volume of epidural injection and relief of radicular leg and low back pain. Methods: We searched MEDLINE (1966 to January 2009), EMBASE (1980 to January 2009), The Cochrane Library, and the reference lists of retrieved articles. The literature search was limited to English and Human subjects. Studies were included if they involved the following: 1) a controlled clinical trial; 2) epidural injections in treatment groups compared with control injections; 3) the same approach to epidural space in both groups; and 4) pain relief as an independent outcome. Trials that measured pain relief for radicular leg and low back pain, before and after epidural injections were included. Using the Cochrane Back Review Group recommendations, pain relief data were extracted independently by two reviewers into four categories: immediate (≤6 weeks); short-term (>6 weeks-3 months); intermediate (≥3 months-1 year); and long-term (≥1 year). Common effect sizes were calculated for each data point. Quality of the trials was assessed (two independent authors) using the 11-item criteria list recommended in the method guidelines for systematic reviews for the Cochrane Back Review Group. The data were analyzed by calculating the following: correlations between volume difference and effect size at each data point; and comparing the average effect sizes in the studies with same volume in both groups to ones with different volumes. Results: Fifteen studies fulfilled the inclusion/exclusion criteria. The correlation between volume difference and pain relief was 0.8027 (p=.002) for the immediate category, 0.5019 (p=.168) for the short-term category, and 0.9470 (p=.014) for the intermediate category. Insufficient data were available to calculate the correlation coefficient in the long-term category. There was a statistically significant difference when comparing the mean effect size where the volume injected was the same between the two groups (mean, standard deviation [SD]: 0.07, -0.26) with those where the volumes were different between comparison groups (mean, SD: 0.81, -0.6), irrespective of the medications injected. Conclusions: These preliminary results suggest a positive correlation between larger volumes of fluid injected in the epidural space and greater relief of radicular leg pain and/or low back pain. Clinicians should not change their practice, until further high-quality clinical studies confirm these findings. © 2009 Elsevier Inc. All rights reserved.

Systematic review

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Authors Novak S , Nemeth WC
Journal Archives of physical medicine and rehabilitation
Year 2008
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OBJECTIVES: To determine the current evidence to support guidelines for frequency and timing of epidural steroid injections (ESIs), to help determine what sort of response should occur to repeat an injection, and to outline specific research needs in these areas. DATA SOURCES: A PubMed, Medline (EBSCO), and Cochrane library search (January 1971-December 2005), as well as additional references found from the initial search. STUDY SELECTION: There were no studies that specifically addressed the objectives outlined. Eleven randomized controlled trials, 1 prospective controlled trial, and 2 prospective cohort studies were identified that included a protocol involving repeat epidural injections for radicular pain secondary to herniated nucleus pulposus or spinal stenosis. One qualitative survey was also identified. Five review articles were also included that discussed this topic. DATA EXTRACTION: Data were extracted from clinical trials if they included the following: (1) protocols in clinical trials on ESIs that included repeat injections and the response required to trigger these injections, (2) any evidence given for establishing these protocols, and (3) similar studies that included only 1 injection. Specific mention of repeat ESIs and partial response that was mentioned in review articles was also included. DATA SYNTHESIS: There is limited evidence to suggest guidelines for frequency and timing of ESIs or to help to define what constitutes the appropriate partial response to trigger a repeat injection. No study has specifically evaluated these objectives. Methodologically limited research suggests that repeat injections may improve outcomes, but the evidence is insufficient to make any conclusions. CONCLUSIONS: There does not appear to be any evidence to support the current common practice of a series of injections. Recommendations for further research are made, including a possible study design.