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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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Journal Cochrane Database of Systematic Reviews
Year 2013
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BACKGROUND: Traction has been used to treat low-back pain (LBP), often in combination with other treatments. We included both manual and machine-delivered traction in this review. This is an update of a Cochrane review first published in 1995, and previously updated in 2006. OBJECTIVES: To assess the effects of traction compared to placebo, sham traction, reference treatments and no treatment in people with LBP. SEARCH METHODS: We searched the Cochrane Back Review Group Specialized Register, the Cochrane Central Register of Controlled Trials (2012, Issue 8), MEDLINE (January 2006 to August 2012), EMBASE (January 2006 to August 2012), CINAHL (January 2006 to August 2012), and reference lists of articles and personal files. The review authors are not aware of any important new randomized controlled trial (RCTs) on this topic since the date of the last search. SELECTION CRITERIA: RCTs involving traction to treat acute (less than four weeks' duration), subacute (four to 12 weeks' duration) or chronic (more than 12 weeks' duration) non-specific LBP with or without sciatica. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. As there were insufficient data for statistical pooling, we performed a descriptive analysis. We did not find any case series that identified adverse effects, therefore we evaluated adverse effects that were reported in the included studies. MAIN RESULTS: We included 32 RCTs involving 2762 participants in this review. We considered 16 trials, representing 57% of all participants, to have a low risk of bias based on the Cochrane Back Review Group's 'Risk of bias' tool. For people with mixed symptom patterns (acute, subacute and chronic LBP with and without sciatica), there was low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status, global improvement or return to work when compared to placebo, sham traction or no treatment. Similarly, when comparing the combination of physiotherapy plus traction with physiotherapy alone or when comparing traction with other treatments, there was very-low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status or global improvement. For people with LBP with sciatica and acute, subacute or chronic pain, there was low- to moderate-quality evidence that traction probably has no impact on pain intensity, functional status or global improvement. This was true when traction was compared with controls and other treatments, as well as when the combination of traction plus physiotherapy was compared with physiotherapy alone. No studies reported the effect of traction on return to work. For chronic LBP without sciatica, there was moderate-quality evidence that traction probably makes little or no difference in pain intensity when compared with sham treatment. No studies reported on the effect of traction on functional status, global improvement or return to work. Adverse effects were reported in seven of the 32 studies. These included increased pain, aggravation of neurological signs and subsequent surgery. Four studies reported that there were no adverse effects. The remaining studies did not mention adverse effects. AUTHORS' CONCLUSIONS: These findings indicate that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP. There is only limited-quality evidence from studies with small sample sizes and moderate to high risk of bias. The effects shown by these studies are small and are not clinically relevant.

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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Authors Tran DQ , Duong S , Finlayson RJ
Journal Canadian journal of anaesthesia = Journal canadien d'anesthésie
Year 2010
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Purpose: The purpose of this brief narrative review is to summarize the evidence derived from randomized controlled trials pertaining to the nonsurgical treatment of lumbar spinal stenosis (LSS). Source: The MEDLINE (January 1950 to the fourth week of January 2010) and EMBASE (January 1980 to 2009, week 53) databases, the MESH term "spinal stenosis", and the key words, "vertebral canal stenosis" and "neurogenic claudication", were searched. Results were limited to randomized controlled trials (RCTs) conducted on human subjects, written in English, and published in peer-reviewed journals. Only RCTs pertaining to nonsurgical treatment were considered. Studies comparing conservative and surgical management or different surgical techniques were not included in the review. Principal findings: The search criteria 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. Conclusions: 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. © 2010 Canadian Anesthesiologists' Society.

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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Journal Pain physician
Year 2009
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Background: Caudal epidural injection of local anesthetics with or without steroids is one of the most commonly used interventions in managing chronic low back and lower extremity pain. However, there has been a lack of well-designed randomized, controlled studies to determine the effectiveness of caudal epidural injections in various conditions - disc herniation and radiculitis, post-lumbar laminectomy syndrome, spinal stenosis, and chronic low back pain of disc origin without disc herniation or radiculitis. Study Design: 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. Objective: 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. Methods: 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). 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. Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term ≥ 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. Results: The evidence showed Level I for short- and 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. Limitations: The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation. Conclusion: 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.

Systematic review

Unclassified

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.