BACKGROUND: A 2007 American College of Physicians guideline addressed pharmacologic options for low back pain. New evidence and medications have now become available.
PURPOSE: To review the current evidence on systemic pharmacologic therapies for acute or chronic nonradicular or radicular low back pain.
DATA SOURCES: Ovid MEDLINE (January 2008 through November 2016), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and reference lists.
STUDY SELECTION: Randomized trials that reported pain, function, or harms of systemic medications versus placebo or another intervention.
DATA EXTRACTION: One investigator abstracted data, and a second verified accuracy; 2 investigators independently assessed study quality.
DATA SYNTHESIS: The number of trials ranged from 9 (benzodiazepines) to 70 (nonsteroidal anti-inflammatory drugs). New evidence found that acetaminophen was ineffective for acute low back pain, nonsteroidal anti-inflammatory drugs had smaller benefits for chronic low back pain than previously observed, duloxetine was effective for chronic low back pain, and benzodiazepines were ineffective for radiculopathy. For opioids, evidence remains limited to short-term trials showing modest effects for chronic low back pain; trials were not designed to assess serious harms. Skeletal muscle relaxants are effective for short-term pain relief in acute low back pain but caused sedation. Systemic corticosteroids do not seem to be effective. For effective interventions, pain relief was small to moderate and generally short-term; improvements in function were generally smaller. Evidence is insufficient to determine the effects of antiseizure medications.
LIMITATIONS: Qualitatively synthesized new trials with prior meta-analyses. Only English-language studies were included, many of which had methodological shortcomings. Medications injected for local effects were not addressed.
CONCLUSION: Several systemic medications for low back pain are associated with small to moderate, primarily short-term effects on pain. New evidence suggests that acetaminophen is ineffective for acute low back pain, and duloxetine is associated with modest effects for chronic low back pain.
PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42014014735).
BACKGROUND: Lumbar spinal stenosis (LSS) is a debilitating condition associated with degeneration of the spine with aging.
OBJECTIVES: To evaluate the effectiveness of different types of surgery compared with different types of non-surgical interventions in adults with symptomatic LSS. Primary outcomes included quality of life, disability, function and pain. Also, to consider complication rates and side effects, and to evaluate short-, intermediate- and long-term outcomes (six months, six months to two years, five years or longer).
SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases and two trials registries up to February 2015. We also screened reference lists and conference proceedings related to treatment of the spine.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing surgical versus non-operative treatments in participants with lumbar spinal stenosis confirmed by clinical and imaging findings.
DATA COLLECTION AND ANALYSIS: For data collection and analysis, we followed methods guidelines of the Cochrane Back and Neck Review Group (Furlan 2009) and those provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
MAIN RESULTS: From the 12,966 citations screened, we assessed 26 full-text articles and included five RCTs (643 participants).Low-quality evidence from the meta-analysis performed on two trials using the Oswestry Disability Index (pain-related disability) to compare direct decompression with or without fusion versus multi-modal non-operative care showed no significant differences at six months (mean difference (MD) -3.66, 95% confidence interval (CI) -10.12 to 2.80) and at one year (MD -6.18, 95% CI -15.03 to 2.66). At 24 months, significant differences favoured decompression (MD -4.43, 95% CI -7.91 to -0.96). Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care (bracing and exercise) at three months (risk ratio (RR) 1.38, 95% CI 0.22 to 8.59), four years (RR 7.50, 95% CI 1.00 to 56.48) and 10 years (RR 4.09, 95% CI 0.95 to 17.58).Low-quality evidence from one small study suggested no differences at six weeks in the Oswestry Disability Index for patients treated with minimally invasive mild decompression versus those treated with epidural steroid injections (MD 5.70, 95% CI 0.57 to 10.83; 38 participants). Zurich Claudication Questionnaire (ZCQ) results were better for epidural injection at six weeks (MD -0.60, 95% CI -0.92 to -0.28), and visual analogue scale (VAS) improvements were better in the mild decompression group (MD 2.40, 95% CI 1.92 to 2.88). At 12 weeks, many cross-overs prevented further analysis.Low-quality evidence from a single study including 191 participants favoured the interspinous spacer versus usual conservative treatment at six weeks, six months and one year for symptom severity and physical function.All remaining studies reported complications associated with surgery and conservative side effects of treatment: Two studies reported no major complications in the surgical group, and the other study reported complications in 10% and 24% of participants, including spinous process fracture, coronary ischaemia, respiratory distress, haematoma, stroke, risk of reoperation and death due to pulmonary oedema.
AUTHORS' CONCLUSIONS: We have very little confidence to conclude whether surgical treatment or a conservative approach is better for lumbar spinal stenosis, and we can provide no new recommendations to guide clinical practice. However, it should be noted that the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. No clear benefits were observed with surgery versus non-surgical treatment. These findings suggest that clinicians should be very careful in informing patients about possible treatment options, especially given that conservative treatment options have resulted in no reported side effects. High-quality research is needed to compare surgical versus conservative care for individuals with lumbar spinal stenosis.
BACKGROUND: The gold standard treatment for symptomatic lumbar stenosis refractory to conservative management is a facet-preserving laminectomy. New techniques of posterior decompression have been developed to preserve spinal integrity and to minimise tissue damage by limiting bony decompression and avoiding removal of the midline structures (i.e. spinous process, vertebral arch and interspinous and supraspinous ligaments).
OBJECTIVES: To compare the effectiveness of techniques of posterior decompression that limit the extent of bony decompression or avoid removal of posterior midline structures of the lumbar spine versus conventional facet-preserving laminectomy for the treatment of patients with degenerative lumbar stenosis.
SEARCH METHODS: An experienced librarian conducted a comprehensive electronic search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science, and the clinical trials registries ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) for relevant literature up to June 2014.
SELECTION CRITERIA: We included prospective controlled studies comparing conventional facet-preserving laminectomy versus a posterior decompressive technique that avoids removal of posterior midline structures or a technique involving only partial resection of the vertebral arch. We excluded studies describing techniques of decompression by means of interspinous process devices or concomitant (instrumented) fusion procedures. Participants included individuals with symptomatic degenerative lumbar stenosis only.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias using the Cochrane Back Review Group criteria for randomised controlled trials (RCTs) and the Newcastle-Ottawa Scale for non-randomised studies. We extracted data regarding demographics, intervention details and outcome measures.
MAIN RESULTS: A total of four high-quality RCTs and six low-quality RCTs met the search criteria of this review. These studies included a total of 733 participants. Investigators compared three different posterior decompression techniques versus conventional laminectomy. Three studies (173 participants) compared unilateral laminotomy for bilateral decompression versus conventional laminectomy. Four studies (382 participants) compared bilateral laminotomy versus conventional laminectomy (one study included three treatment groups and compared unilateral and bilateral laminotomy vs conventional laminectomy). Finally, four studies (218 participants) compared a split-spinous process laminotomy versus conventional laminectomy.Evidence of low or very low quality suggests that different techniques of posterior decompression and conventional laminectomy have similar effects on functional disability and leg pain. Only perceived recovery at final follow-up was better in people who underwent bilateral laminotomy compared with conventional laminectomy (two RCTs, 223 participants, odds ratio 5.69, 95% confidence interval (CI) 2.55 to 12.71).Among the secondary outcome measures, unilateral laminotomy for bilateral decompression and bilateral laminotomy resulted in numerically fewer cases of iatrogenic instability, although in both cases, the incidence of instability was low (three RCTs, 166 participants, odds ratio 0.28, 95% CI 0.07 to 1.15; three RCTs, 294 participants, odds ratio 0.10, 95% CI 0.02 to 0.55, respectively). The difference in severity of postoperative low back pain following bilateral laminotomy (two RCTs, 223 participants, mean difference -0.51, 95% CI -0.80 to -0.23) and split-spinous process laminotomy compared with conventional laminectomy (two RCTs, 97 participants, mean difference -1.07, 95% CI -2.15 to -0.00) was significantly less, but was too small to be clinically important. A quantitative comparison between unilateral laminotomy and conventional laminectomy was not possible because of different reporting of outcome measures. We found no evidence to show that the incidence of complications, length of the procedure, length of hospital stay and postoperative walking distance differed between techniques of posterior decompression.
AUTHORS' CONCLUSIONS: The evidence provided by this systematic review for the effects of unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy compared with conventional laminectomy on functional disability, perceived recovery and leg pain is of low or very low quality. Therefore, further research is necessary to establish whether these techniques provide a safe and effective alternative for conventional laminectomy. Proposed advantages of these techniques regarding the incidence of iatrogenic instability and postoperative back pain are plausible, but definitive conclusions are limited by poor methodology and poor reporting of outcome measures among included studies. Future research is necessary to establish the incidence of iatrogenic instability using standardised definitions of radiological and clinical instability at comparable follow-up intervals. Long-term results with these techniques are currently lacking.
BACKGROUND: To investigate whether calcitonin can improve walking distance (WD) and visual analog pain scale (VAS) in patients who suffer lumbar spinal stenosis (LSS).
METHODS: We performed a search on CENTRAL, PubMed, Embase and Cochrane databases up to July 2014; we finally found 19 original articles, of which only 6 were in full compliance with the RCT criteria. These full articles were carefully reviewed independent and in blinded way by two previously capacitated reviewers for the objective to extract data and score a quality of these articles by the criteria of Cochrane Handbook (5.1.0).
RESULTS: We accepted 6 studies with 232 participants. There is no evidence show calcitonin is better than placebo or paracetamol regardless of mode of administration.
CONCLUSIONS: This meta-analysis suggest that calcitonin provide no significant improvement in pain symptoms or walking distance in LSS patients.
PURPOSE: To investigate the effectiveness and safety of epidural steroid injections in patients with lumbar spinal stenosis (LSS).
METHODS: We performed a search on the CENTRAL, Pubmed, Embase and Cochrane databases up to September 2014. We recovered 17 original articles, of which only 10 were in full compliance with the randomized controlled trial (RCT) criteria. These articles were reviewed in an independent and blinded way by two reviewers who were previously trained to extract data and score their quality by the criteria of the Cochrane Handbook (5.1.0).
RESULTS: We accepted ten studies with 1,010 participants. There is minimal evidence that shows that epidural steroid injections are better than lidocaine alone, regardless of the mode of epidural injection. There is a fair short-term and long-term benefit for treating spinal stenosis with local anesthetic and steroids.
CONCLUSIONS: This meta-analysis suggests that epidural steroid injections provide limited improvement in short-term and long-term benefits in LSS patients.
CONTEXT: Lumbar central spinal stenosis is common and often results in chronic persistent pain and disability, which can lead to multiple interventions. After the failure of conservative treatment, either surgical or nonsurgical modalities such as epidural injections are contemplated in the management of lumbar spinal stenosis.
EVIDENCE ACQUISITION: Recent randomized trials, systematic reviews and guidelines have reached varying conclusions about the efficacy of epidural injections in the management of central lumbar spinal stenosis. The aim of this systematic review was to determine the efficacy of all three anatomical epidural injection approaches (caudal, interlaminar, and transforaminal) in the treatment of lumbar central spinal stenosis. A systematic review was performed on randomized trials published from 1966 to July 2014 of all types of epidural injections used in the management of lumbar central spinal stenosis. Methodological quality assessment and grading of the evidence was performed.
RESULTS: The evidence in managing lumbar spinal stenosis is Level II for long-term improvement for caudal and lumbar interlaminar epidural injections. For transforaminal epidural injections, the evidence is Level III for short-term improvement only. The interlaminar approach appears to be superior to the caudal approach and the caudal approach appears to be superior to the transforaminal one.
CONCLUSIONS: The available evidence suggests that epidural injections with local anesthetic alone or with local anesthetic with steroids offer short- and long-term relief of low back and lower extremity pain for patients with lumbar central spinal stenosis. However, the evidence is Level II for the long-term efficacy of caudal and interlaminar epidural injections, whereas it is Level III for short-term improvement only with transforaminal epidural injections.
BACKGROUND: Lumbar spinal stenosis is the most common reason for spinal surgery in elderly patients. However, the surgical management of spinal stenosis is controversial. The aim of this review was to list aspects a surgeon considers when choosing a specific type of treatment.
METHODS: Appraisal of arguments reported in randomized controlled trials (RCTs) included in systematic reviews published or indexed in the Cochrane library studying surgical treatments in patients with spinal stenosis.
RESULTS: Eight out of nine RCTs listed arguments for the choice of their treatments under investigation. The argument for decompression alone was the high success rate, the argument against was a potential increase in vertebral instability. The argument for decompression and fusion without instrumentation was that it is a well-established technique with a high fusion success rate, the argument against it was that the indication for fusion in spinal stenosis has remained unclear. The argument for decompression and fusion with instrumentation was an increased fusion rate compared to decompression and fusion without instrumentation, the argument against this was that the invasive procedure is associated with more complications.
CONCLUSIONS: The main argument identified in this appraisal for and against decompression alone in patient with lumbar spinal stenosis was whether or not instability should be treated with (instrumented) fusion procedures. However, there is disagreement on how instability should be defined. In a first step it is important that researchers and clinicians agree on definitions for important key concepts such as instability and reoperations.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
<b>PURPOSE: </b>To compare the effectiveness of techniques of posterior decompression that limit the extent of bony decompression or to avoid removal of posterior midline structures of the lumbar spine versus conventional facet-preserving laminectomy for the treatment of patients with degenerative lumbar stenosis.<b>METHODS: </b>A comprehensive electronic search of the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Web of Science, and the clinical trials registries ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform was conducted for relevant literature up to June 2014.<b>RESULTS: </b>A total of four high-quality RCTs and six low-quality RCTs met the search criteria of this review. These studies included a total of 733 participants. Three different techniques that avoid removal of posterior midline structures are compared to conventional laminectomy; unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy. Evidence of low or very low quality suggests that different techniques of posterior decompression and conventional laminectomy have similar effects on functional disability and leg pain. Only perceived recovery at final follow-up was better in patients that underwent bilateral laminotomy compared with conventional laminectomy. Unilateral laminotomy for bilateral decompression and bilateral laminotomy resulted in numerically fewer cases of iatrogenic instability, although in both cases, the incidence of instability was low. The difference in severity of postoperative low back pain following bilateral laminotomy and split-spinous process laminotomy was significantly less, but was too small to be clinically important. We found no evidence to show that the incidence of complications, length of the procedure, length of hospital stay and postoperative walking distance differed between techniques of posterior decompression.<b>CONCLUSION: </b>The evidence provided by this systematic review for the effects of unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy compared with conventional laminectomy on functional disability, perceived recovery and leg pain is of low or very low quality. Therefore, further research is necessary to establish whether these techniques provide a safe and effective alternative for conventional laminectomy. Proposed advantages of these techniques regarding the incidence of iatrogenic instability and postoperative back pain are plausible, but definitive conclusions are limited by poor methodology and poor reporting of outcome measures among included studies.
BACKGROUND: There is a strong tradition of performing a clinical examination of low back pain (LBP) patients and this is generally recommended in guidelines. However, establishing a pathoanatomic diagnosis does not seem possible in most LBP patients and clinical tests may potentially be more relevant as prognostic factors. The aim of this review of the literature was to systematically assess the association between low-tech clinical tests commonly used in adult patients with acute, recurrent or chronic LBP and short- and long-term outcome.
METHODS: MEDLINE, Embase, and MANTIS were searched from inception to June 2012. Prospective clinical studies of adult patients with LBP with or without leg pain and/or signs of nerve root involvement or spinal stenosis, receiving non-surgical or no treatment, which investigated the association between low-tech clinical tests and outcome were included. Study selection, data extraction and appraisal of study quality were performed independently by two reviewers.
RESULTS: A total of 5,332 citations were retrieved and screened for eligibility, 342 articles were assessed as full text and 49 met the inclusion criteria. Due to clinical and statistical heterogeneity, qualitative synthesis rather than meta-analysis was performed. Associations between clinical tests and outcomes were often inconsistent between studies. In more than one third of the tests, there was no evidence of the tests being associated with outcome. Only two clinical tests demonstrated a consistent association with at least one of the outcomes: centralization and non-organic signs.
CONCLUSIONS: For most clinical tests in LBP there is not consistent evidence for an association with outcome. Centralization and non-organic signs are exceptions from that. None of the other clinical tests have been investigated in confirmatory studies and study quality is generally low. There is a need for hypothesis testing studies designed specifically to investigate the prognostic value of the clinical tests, and a need for standardization of the performance and interpretation of tests.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
PURPOSE: This systematic review summarises the literature on patient selection, decision-making, effectiveness and outcomes in the surgical treatment of lumbar degenerative spondylolisthesis (LDS).
INTRODUCTION: In daily practice, decision-making in the treatment of LDS is challenging. There is little consensus on either the precise indications or prognostic factors for any specific therapy (operative or non-operative).
METHODS: We searched for LDS trials published between 01.01.1990 and 16.11.2011 in Medline, Embase, Cochrane Library and Cinahl. Two independent reviewers selected studies according to the inclusion criteria. Data were then extracted by two of the authors. Quality assessment was performed using the Downs and Black list for the clinical trials/studies and AMSTAR for the reviews.
RESULTS: None
DATA SYNTHESIS: 21 papers met the inclusion criteria (2 studies comprising both a RCT and a concurrent observational analysis, 1 RCT, 6 prospective studies, 8 retrospective studies, 3 reviews, 1 review guideline). The quality of the clinical studies was on average "fair" [mean score 15.6 points (range 10-19) out of 24 points (Downs and Black)]. The quality of the reviews ranged from 1 to 7 out of 11 points with an average of 5 points (AMSTAR). The study outcomes could not be subject to meta-analysis due to heterogeneity of study design and variable measure used.
CONCLUSIONS: Despite there being many articles describing and/or comparing different surgical options for LDS, there was insufficient evidence to draw conclusions concerning clear indications for specific types of surgical treatment, predictors of outcome or complication rates. There remains a need to establish a decision-making tool to facilitate daily clinical practice and to assure appropriate treatment for patients with LDS.
A 2007 American College of Physicians guideline addressed pharmacologic options for low back pain. New evidence and medications have now become available.
PURPOSE:
To review the current evidence on systemic pharmacologic therapies for acute or chronic nonradicular or radicular low back pain.
DATA SOURCES:
Ovid MEDLINE (January 2008 through November 2016), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and reference lists.
STUDY SELECTION:
Randomized trials that reported pain, function, or harms of systemic medications versus placebo or another intervention.
DATA EXTRACTION:
One investigator abstracted data, and a second verified accuracy; 2 investigators independently assessed study quality.
DATA SYNTHESIS:
The number of trials ranged from 9 (benzodiazepines) to 70 (nonsteroidal anti-inflammatory drugs). New evidence found that acetaminophen was ineffective for acute low back pain, nonsteroidal anti-inflammatory drugs had smaller benefits for chronic low back pain than previously observed, duloxetine was effective for chronic low back pain, and benzodiazepines were ineffective for radiculopathy. For opioids, evidence remains limited to short-term trials showing modest effects for chronic low back pain; trials were not designed to assess serious harms. Skeletal muscle relaxants are effective for short-term pain relief in acute low back pain but caused sedation. Systemic corticosteroids do not seem to be effective. For effective interventions, pain relief was small to moderate and generally short-term; improvements in function were generally smaller. Evidence is insufficient to determine the effects of antiseizure medications.
LIMITATIONS:
Qualitatively synthesized new trials with prior meta-analyses. Only English-language studies were included, many of which had methodological shortcomings. Medications injected for local effects were not addressed.
CONCLUSION:
Several systemic medications for low back pain are associated with small to moderate, primarily short-term effects on pain. New evidence suggests that acetaminophen is ineffective for acute low back pain, and duloxetine is associated with modest effects for chronic low back pain.
