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: 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: 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.
Background. Physical therapy is commonly prescribed for patients with lumbar spinal stenosis (LSS); however, little is known about its effectiveness. Purpose. The purpose of this study was to systematically review randomized controlled trials (RCTs), controlled trials, and cohort studies evaluating the effectiveness of physical therapy for LSS. Data Sources. Studies were searched on electronic databases to January 2012. Study Selection. Inclusion criteria were: clinical diagnosis of LSS with confirmatory imaging, evaluation of physical therapy treatment, presence of a comparison group, and outcomes of pain, disability, function, or quality of life. Data Extraction. Outcomes were extracted and, when possible, pooled using RevMan 5, a freely available review program from the Cochrane Library. Data Synthesis. Ten studies were included: 5 RCTs, 2 controlled trials, 2 mixed- design studies, and 1 longitudinal cohort study. Pooled effects of 2 studies revealed that the addition of a physical therapy modality to exercise had no statistically significant effect on outcome. Pooled effects results of RCTs evaluating surgery versus physical therapy demonstrated that surgery was better than physical therapy for pain and disability at long term (2 years) only. Other results suggested that exercise is significantly better than no exercise, that cycling and body-weight-supported treadmill walking have similar effects, and that corsets are better than no corsets. Limitations. The limitations of this review include the low quality and small number of studies, as well as the heterogeneity in outcomes and treatments. Conclusions. No conclusions could be drawn from the review regarding which physical therapy treatment is superior for LSS. There was low-quality evidence suggesting that modalities have no additional effect to exercise and that surgery leads to better long-term (2 years) outcomes for pain and disability, but not walking distance, than physical therapy in patients with LSS.
CONTEXT: Both spondylolysis and spondylolisthesis can be diagnosed across the life span of sports-participating individuals. Determining which treatments are effective for these conditions is imperative to the rehabilitation professional.
DATA SOURCES: A computer-assisted literature search was completed in MEDLINE, CINAHL, and EMBASE databases (1966-April 2012) utilizing keywords related to nonoperative treatment of spondylolysis and/or spondylolisthesis. Reference lists were also searched to find all relevant articles that fit our inclusion criteria: English language, human, lumbar pain with diagnosed spondylolysis and/or spondylolisthesis, inclusion of at least 1 nonoperative treatment method, and use of a comparative study design.
DATA EXTRACTION: Data were independently extracted from the selected studies by 2 authors and cross-referenced. Any disagreement on relevant data was discussed and resolved by a third author.
RESULTS: Ten studies meeting the criteria were rated for quality using the GRADE scale. Four studies found surgical intervention more successful than nonoperative treatment for treating pain and functional limitation. One study found no difference between surgery and nonoperative treatment with regard to future low back pain. Improvement was found in bracing, bracing and exercises emphasizing lumbar extension, range of motion and strengthening exercises focusing on lumbar flexion, and strengthening specific abdominal and lumbar muscles.
CONCLUSION: No consensus can be reached on the role of nonoperative versus surgical care because of limited investigation and heterogeneity of studies reported. Studies of nonoperative care options suffered from lack of blinding assessors and control groups and decreased patient compliance with exercise programs.
BACKGROUND: Lumbar spinal stenosis with neurogenic claudication is one of the most commonly diagnosed and treated pathological spinal conditions. It frequently afflicts the elderly population.
OBJECTIVES: To systematically review the evidence for the effectiveness of nonoperative treatment of lumbar spinal stenosis with neurogenic claudication.
SEARCH METHODS: CENTRAL, MEDLINE, CINAHL, and Index to Chiropractic Literature (ICL) databases were searched up to June 2012.
SELECTION CRITERIA: Randomized controlled trials published in English, in which at least one arm provided data on nonoperative treatments
DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by The Cochrane Collaboration. Risk of bias in each study was independently assessed by two review authors using the 12 criteria recommended by the Cochrane Back Review Group (Furlan 2009). Dichotomous outcomes were expressed as relative risk, continuous outcomes as mean difference or standardized mean difference; uncertainty was expressed with 95% confidence intervals. If possible a meta-analysis was performed, otherwise results were described qualitatively. GRADE was used to assess the quality of the evidence.
MAIN RESULTS: From the 8635 citations screened, 56 full-text articles were assessed and 21 trials (1851 participants) were included. There was very low-quality evidence from six trials that calcitonin is no better than placebo or paracetamol, regardless of mode of administration or outcome assessed. From single small trials, there was low-quality evidence for prostaglandins, and very low-quality evidence for gabapentin or methylcobalamin that they improved walking distance. There was very low-quality evidence from a single trial that epidural steroid injections improved pain, function, and quality of life, up to two weeks, compared with home exercise or inpatient physical therapy. There was low-quality evidence from a single trial that exercise is of short-term benefit for leg pain and function compared with no treatment. There was low and very low-quality evidence from six trials that multimodal nonoperative treatment is less effective than indirect or direct surgical decompression with or without fusion. A meta-analysis of two trials comparing direct decompression with or without fusion to multimodal nonoperative care found no significant difference in function at six months (mean difference (MD) -3.66, 95% CI -10.12 to 2.80) and one year (MD -6.18, 95% CI -15.03 to 2.66), but at 24 months a significant difference was found favouring decompression (MD -4.43, 95% CI -7.91 to -0.96).
AUTHORS' CONCLUSIONS: Moderate and high-quality evidence for nonoperative treatment is lacking and thus prohibits recommendations for guiding clinical practice. Given the expected exponential rise in the prevalence of lumbar spinal stenosis with neurogenic claudication, large high-quality trials are urgently needed.
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.
