Clinical care standards for the management of low back pain: a scoping review.

The objective of this study is to compare and contrast the quality statements and quality indicators across clinical care standards for low back pain. Searches were performed in Medline, guideline databases, and Google searches to identify clinical care standards for the management of low back pain targeting a multidisciplinary audience. Two independent reviewers reviewed the search results and extracted relevant information from the clinical care standards. We compared the quality statements and indicators of the clinical care standards to identify the consistent messages and the discrepancies between them. Three national clinical care standards from Australia, Canada, and the United Kingdom were included. They provided from 6 to 8 quality statements and from 12 to 18 quality indicators. The three standards provide consistent recommendations in the quality statements related to imaging, and patient education/advice and self-management. In addition, the Canadian and Australian standards also provide consistent recommendations regarding comprehensive assessment, psychological support, and review and patient referral. However, the three clinical care standards differ in the statements related to psychological assessment, opioid analgesics, non-opioid analgesics, and non-pharmacological therapies. The three national clinical care standards provide consistent recommendations on imaging and patient education/advice, self-management of the condition, and two standards (Canadian and Australian) agree on recommendations regarding comprehensive assessment, psychological support, and review and patient referral. The standards differ in the quality statements related to psychological assessment, opioid prescription, non-opioid analgesics, and non-pharmacological therapies.

Clinical indicators to monitor health care in low back pain: a scoping review.

Clinical care indicators for low back pain can be used to monitor healthcare practices and consequently be used to evaluate success of strategies to improve care quality. The aim of this study was to identify the clinical care indicators that have been used to measure appropriateness of health care for patients with low back pain. We conducted a systematic search of five electronic databases and Google to identify clinical care indicators that have been used to measure any aspect of care for people with low back pain. Care indicators were narratively described according to their type (i.e. structure, process, or outcomes) and categorized by their purpose (e.g. to measure aspects related to assessment, imaging requests, treatment/prevention, and outcomes). A total of 3562 and 2180 records were retrieved from electronic databases and Google searches, respectively. We identified 280 indicators related to low back pain care from 40 documents and publications. Most quality indicators were process indicators (n = 213, 76%), followed by structure (n = 41, 15%) and outcome indicators (n = 26, 9%). The most common indicators were related to imaging requests (n = 41, 15%), referral to healthcare providers (n = 30, 11%), and shared decision-making (n = 21, 7%). Our review identified a range of clinical care indicators that have been used to measure the quality of health care for people with low back pain. Our findings will support a Delphi study to reach international consensus on what would be the most important and feasible indicators for a minimum dataset to be collected globally.

The effectiveness of allied health and nurse practitioner models-of-care in managing musculoskeletal conditions in the emergency department: a systematic review and meta-analysis.

BACKGROUND: Musculoskeletal conditions are the most common health condition seen in emergency departments. Hence, the most effective approaches to managing these conditions is of interest. This systematic review aimed to evaluate the effectiveness of allied health and nursing models of care for the management of musculoskeletal pain in ED. METHODS: MEDLINE, EMBASE, CINAHL and LILACS databases were searched from inception to March 2023 for published randomised trials that compared the effectiveness of allied health and nursing models of care for musculoskeletal conditions in ED to usual ED care. Trials were eligible if they enrolled participants presenting to ED with a musculoskeletal condition including low back pain, neck pain, upper or lower limb pain and any soft tissue injury. Trials that included patients with serious pathology (e.g. malignancy, infection or cauda equina syndrome) were excluded. The primary outcome was patient-flow; other outcomes included pain intensity, disability, hospital admission and re-presentation rates, patient satisfaction, medication prescription and adverse events. Two reviewers performed search screening, data extraction, quality and certainty of evidence assessments. RESULTS: We identified 1746 records and included 5 randomised trials (n = 1512 patients). Only one trial (n = 260) reported on patient-flow. The study provides very-low certainty evidence that a greater proportion of patients were seen within 20 min when seen by a physician (98%) than when seen by a nurse (86%) or physiotherapist (77%). There was no difference in pain intensity and disability between patients managed by ED physicians and those managed by physiotherapists. Evidence was limited regarding patient satisfaction, inpatient admission and ED re-presentation rates, medication prescription and adverse events. The certainty of evidence for secondary outcomes ranged from very-low to low, but generally did not suggest a benefit of one model over another. CONCLUSION: There is limited research to judge the effectiveness of allied health and nursing models of care for the management of musculoskeletal conditions in ED. Currently, it is unclear as to whether allied health and nurse practitioners are more effective than ED physicians at managing musculoskeletal conditions in ED. Further high-quality trials investigating the impact of models of care on service and health outcomes are needed.

Red flags to screen for vertebral fracture in people presenting with low back pain.

BACKGROUND: Low back pain is a common presentation across different healthcare settings. Clinicians need to confidently be able to screen and identify people presenting with low back pain with a high suspicion of serious or specific pathology (e.g. vertebral fracture). Patients identified with an increased likelihood of having a serious pathology will likely require additional investigations and specific treatment. Guidelines recommend a thorough history and clinical assessment to screen for serious pathology as a cause of low back pain. However, the diagnostic accuracy of recommended red flags (e.g. older age, trauma, corticosteroid use) remains unclear, particularly those used to screen for vertebral fracture. OBJECTIVES: To assess the diagnostic accuracy of red flags used to screen for vertebral fracture in people presenting with low back pain. Where possible, we reported results of red flags separately for different types of vertebral fracture (i.e. acute osteoporotic vertebral compression fracture, vertebral traumatic fracture, vertebral stress fracture, unspecified vertebral fracture). SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 26 July 2022. SELECTION CRITERIA: We considered primary diagnostic studies if they compared results of history taking or physical examination (or both) findings (index test) with a reference standard test (e.g. X-ray, magnetic resonance imaging (MRI), computed tomography (CT), single-photon emission computerised tomography (SPECT)) for the identification of vertebral fracture in people presenting with low back pain. We included index tests that were presented individually or as part of a combination of tests. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data for diagnostic two-by-two tables from the publications or reconstructed them using information from relevant parameters to calculate sensitivity, specificity, and positive (+LR) and negative (-LR) likelihood ratios with 95% confidence intervals (CIs). We extracted aspects of study design, characteristics of the population, index test, reference standard, and type of vertebral fracture. Meta-analysis was not possible due to heterogeneity of studies and index tests, therefore the analysis was descriptive. We calculated sensitivity, specificity, and LRs for each test and used these as an indication of clinical usefulness. Two review authors independently conducted risk of bias and applicability assessment using the QUADAS-2 tool. MAIN RESULTS: This review is an update of a previous Cochrane Review of red flags to screen for vertebral fracture in people with low back pain. We included 14 studies in this review, six based in primary care, five in secondary care, and three in tertiary care. Four studies reported on 'osteoporotic vertebral fractures', two studies reported on 'vertebral compression fracture', one study reported on 'osteoporotic and traumatic vertebral fracture', two studies reported on 'vertebral stress fracture', and five studies reported on 'unspecified vertebral fracture'. Risk of bias was only rated as low in one study for the domains reference standard and flow and timing. The domain patient selection had three studies and the domain index test had six studies rated at low risk of bias. Meta-analysis was not possible due to heterogeneity of the data. Results from single studies suggest only a small number of the red flags investigated may be informative. In the primary healthcare setting, results from single studies suggest 'trauma' demonstrated informative +LRs (range: 1.93 to 12.85) for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture' (+LR: 6.42, 95% CI 2.94 to 14.02). Results from single studies suggest 'older age' demonstrated informative +LRs for studies in primary care for 'unspecified vertebral fracture' (older age greater than 70 years: 11.19, 95% CI 5.33 to 23.51). Results from single studies suggest 'corticosteroid use' may be an informative red flag in primary care for 'unspecified vertebral fracture' (+LR range: 3.97, 95% CI 0.20 to 79.15 to 48.50, 95% CI 11.48 to 204.98) and 'osteoporotic vertebral fracture' (+LR: 2.46, 95% CI 1.13 to 5.34); however, diagnostic values varied and CIs were imprecise. Results from a single study suggest red flags as part of a combination of index tests such as 'older age and female gender' in primary care demonstrated informative +LRs for 'unspecified vertebral fracture' (16.17, 95% CI 4.47 to 58.43). In the secondary healthcare setting, results from a single study suggest 'trauma' demonstrated informative +LRs for 'unspecified vertebral fracture' (+LR: 2.18, 95% CI 1.86 to 2.54) and 'older age' demonstrated informative +LRs for 'osteoporotic vertebral fracture' (older age greater than 75 years: 2.51, 95% CI 1.48 to 4.27). Results from a single study suggest red flags as part of a combination of index tests such as 'older age and trauma' in secondary care demonstrated informative +LRs for 'unspecified vertebral fracture' (+LR: 4.35, 95% CI 2.92 to 6.48). Results from a single study suggest when '4 of 5 tests' were positive in secondary care, they demonstrated informative +LRs for 'osteoporotic vertebral fracture' (+LR: 9.62, 95% CI 5.88 to 15.73). In the tertiary care setting, results from a single study suggest 'presence of contusion/abrasion' was informative for 'vertebral compression fracture' (+LR: 31.09, 95% CI 18.25 to 52.96). AUTHORS' CONCLUSIONS: The available evidence suggests that only a few red flags are potentially useful in guiding clinical decisions to further investigate people suspected to have a vertebral fracture. Most red flags were not useful as screening tools to identify vertebral fracture in people with low back pain. In primary care, 'older age' was informative for 'unspecified vertebral fracture', and 'trauma' and 'corticosteroid use' were both informative for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture'. In secondary care, 'older age' was informative for 'osteoporotic vertebral fracture' and 'trauma' was informative for 'unspecified vertebral fracture'. In tertiary care, 'presence of contusion/abrasion' was informative for 'vertebral compression fracture'. Combinations of red flags were also informative and may be more useful than individual tests alone. Unfortunately, the challenge to provide clear guidance on which red flags should be used routinely in clinical practice remains. Further research with primary studies is needed to improve and consolidate our current recommendations for screening for vertebral fractures to guide clinical care.

Australian emergency department care for older adults diagnosed with low back pain of lumbar spine origin: a retrospective analysis of electronic medical record system data (2016-2019).

BACKGROUND: In Australian emergency departments, 30% of all back pain presentations are for older adults. Relatively little is known about the care that this population receives during an emergency department stay, including admission to hospital. The aim of this study is to describe emergency department management of older adults diagnosed with a lumbar spine condition and to determine predictors of healthcare use in this population. METHODS: A retrospective analysis of electronic medical record data of adults aged ≥ 65 years with a lumbar spine discharge diagnosis. Demographic, clinical care (date and time of presentation and discharge, length of stay in the emergency department, mode of arrival, triage category, re-presentations to the emergency department (within 48 h), discharge mode, the administration of pain-relieving medicines, lumbar imaging, and laboratory tests) and costs data were extracted from the electronic medical record system. Descriptive analyses and multilevel mixed-effects logistic regression models were performed. RESULTS: Over the period January 2016 to December 2019 there were 4,093 presentations to emergency departments by older adults with a lumbar spine discharge diagnosis (82.0% were non-specific low back pain). Most were female (58.3%), 39.9% had some form of lumbar imaging, and 34.1% were admitted to hospital. The most administered pain medicines were opioid analgesics (67.1%), followed by paracetamol (63.9%) and NSAIDs (33.0%). Predictors of healthcare use and hospital inpatient admission were receiving a laboratory test and receiving any opioid. For the financial period 2019-20, the mean (SD) total cost of care per presentation was $5,629 ($11,982). CONCLUSION: In the emergency department, more than two thirds of older adults with a lumbar spine condition received opioid analgesics. They often received imaging and laboratory tests, had high costs and were admitted to hospital. Alternative pathways of care are needed to support older adults with low back pain, to receive guideline-concordant emergency department care and have good health outcomes.

Do Patients with Acute Low Back Pain in Emergency Departments Have More Severe Symptoms than Those in General Practice? ASystematic Review with Meta-Analysis.

INTRODUCTION: There is a common belief that patients presenting to emergency departments have more severe pain levels and functional limitations than those who are seen in general practice. The aim of this systematic review was to compare pain and disability levels of patients with acute low back pain presenting to general practice vs those presenting to emergency departments. METHODS: Electronic searches were conducted in MEDLINE, EMBASE, and CINAHL from database inception to February 2019. Observational studies including patients with acute non-specific low back pain presenting to emergency departments and/or general practice were eligible. Pain and/or disability scores expressed on a 0-100 scale were the primary outcomes. Risk of bias was evaluated with a validated tool for observational studies, and the overall quality of evidence was assessed with Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Meta-analysis with random effects and meta-regression were used to test for differences between the two settings. RESULTS: We included 12 records reporting results for 10 unique studies with a total of 6,999 participants from general practice (n = 6) and emergency departments (n = 4). There was low-quality evidence (downgraded for indirectness and inconsistency) that patients presenting to emergency departments had higher pain scores than those in general practice, with a mean difference of 17.3 points (95% confidence interval: 8.8 to 25.9 on a 0-100 scale). Similarly, there was low-quality evidence (downgraded for indirectness and inconsistency) that patients presenting to emergency departments had higher disability scores than those in general practice (mean difference: 21.7; 95% confidence interval: 4.6 to 38.7 on a 0-100 scale). CONCLUSION: Patients with acute non-specific low back pain presenting to emergency departments may report higher levels of pain and disability than those seen in general practice.

Effectiveness of brief patient information materials for promoting correct beliefs about imaging and inevitable consequences of low back pain: A randomised controlled trial.

OBJECTIVE: To investigate what format for providing patient information (i.e. written summary, infographic or video animation) is most effective for promoting correct beliefs about imaging and inevitable consequences of low back pain (LBP). DESIGN: Randomised controlled trial. SETTING/PATIENTS: One hundred and fifty-nine patients with non-specific LBP were recruited from outpatient physiotherapy clinics. INTERVENTION: Participants were randomised to receive patient information in one of three formats: video animation, infographic or written summary. Patients were allowed to read or watch the materials for up to 20 min. MEASUREMENTS: Outcome were assessed before and immediately after the intervention. The primary outcome was the Back Beliefs Questionnaire. The secondary outcome was beliefs about imaging for LBP assessed by two questions. RESULTS: All 159 patients completed the study. Our findings revealed no difference between groups for the Back Beliefs Questionnaire. Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4; Question 2- OR = 3.7, 95%CI: 1.6, 8.5). No difference between infographic and written summary formats were reported for the questions assessing LBP imaging beliefs. CONCLUSION: The three materials were equally effective in improving patient's general beliefs about LBP care. However, the traditional written summary or infographic formats were more effective than the video animation format for improving beliefs about imaging for LBP.

Paramedic management of back pain: a scoping review.

BACKGROUND: Research examining paramedic care of back pain is limited. OBJECTIVE: To describe ambulance service use and usual paramedic care for back pain, the effectiveness and safety of paramedic care of back pain, and the characteristics of people with back pain who seek care from paramedics. METHODS: We included published peer-reviewed studies of people with back pain who received any type of paramedic care on-scene and/or during transport to hospital. We searched MEDLINE, EMBASE, CINAHL, Web of Science and SciELO from inception to July 2022. Two authors independently screened and selected the studies, performed data extraction, and assessed the methodological quality using the PEDro, AMSTAR 2 and Hawker tools. This review followed the JBI methodological guidance for scoping reviews and PRISMA extension for scoping reviews. RESULTS: From 1987 articles we included 26 articles (25 unique studies) consisting of 22 observational studies, three randomised controlled trials and one review. Back pain is frequently in the top 3 reasons for calls to an ambulance service with more than two thirds of cases receiving ambulance dispatch. It takes ~ 8 min from time of call to an ambulance being dispatched and 16% of calls for back pain receive transport to hospital. Pharmacological management of back pain includes benzodiazepines, NSAIDs, opioids, nitrous oxide, and paracetamol. Non-pharmacological care is poorly reported and includes referral to alternate health service, counselling and behavioural interventions and self-care advice. Only three trials have evaluated effectiveness of paramedic treatments (TENS, active warming, and administration of opioids) and no studies provided safety or costing data. CONCLUSION: Paramedics are frequently responding to people with back pain. Use of pain medicines is common but varies according to the type of back pain and setting, while non-pharmacological care is poorly reported. There is a lack of research evaluating the effectiveness and safety of paramedic care for back pain.

Appropriateness of imaging decisions for low back pain presenting to the emergency department: a retrospective chart review study.

BACKGROUND: Imaging for low back pain is widely regarded as a target for efforts to reduce low-value care. OBJECTIVE: We aimed to estimate the prevalence of the overuse and underuse of lumbar imaging in patients presenting with low back pain to the emergency department (ED). METHODS: This was a retrospective chart review study of five public hospital EDs in Sydney, Australia, in 2019-20. We reviewed the clinical charts of consecutive adult patients who presented with a complaint of low back pain and extracted clinical features relevant to a decision to request lumbar imaging. We estimated the proportion of encounters where a decision to request lumbar imaging was inappropriate (overuse) or where a clinician did not request an appropriate and informative lumbar imaging test when indicated (underuse). RESULTS: Six hundred and forty-nine patients presented with a complaint of low back pain, of which 158 (24.3%) were referred for imaging. Seventy-nine (12.2%) had a combination of features suggesting that lumbar imaging was indicated according to clinical guidelines. The prevalence of overuse and underuse of lumbar imaging was 8.8% (57 of 649 cases, 95% CI 6.8-11.2%) and 4.3% (28 of 649 cases, 95% CI 3.0-6.1%), respectively. Thirteen cases were classified as underuse because the patients were referred for uninformative imaging modalities (e.g. referred for radiography for suspected cauda equina syndrome). CONCLUSION: In this study of emergency care, there was evidence of not only overuse of lumbar imaging but also underuse through failure to request lumbar imaging when indicated or referral for an uninformative imaging modality. These three issues seem more important targets for quality improvement than solely focusing on overuse.

Clinical course of patients with low back pain following an emergency department presentation: a systematic review and meta-analysis.

INTRODUCTION: Low back pain, and especially non-specific low back pain, is a common cause of presentation to the emergency department (ED). Although these patients typically report relatively high pain intensity, the clinical course of their pain and disability remains unclear. Our objective was to review the literature and describe the clinical course of non-specific low back pain after an ED visit. METHODS: Electronic searches were conducted using MEDLINE, CINAHL and EMBASE from inception to March 2019. We screened for cohort studies or randomised trials investigating pain or disability in patients with non-specific low back pain presenting to EDs. We excluded studies that enrolled participants with minimal pain or disability scores at baseline. Two reviewers independently screened the full texts, extracted the data and assessed risk of bias and quality of evidence. Estimates of pain and disability were converted to a common 0-100 scale. We estimated pooled means and 95% CIs of pain and disability as a function of time since ED presentation. RESULTS: Eight studies (nine publications) with a total of 1994 patients provided moderate overall quality evidence of the expected clinical course of low back pain after an ED visit. Seven of the eight studies were assessed to have a low risk of bias. At the time of the ED presentation, the pooled estimate of the mean pain score on a 0-100 scale was 71.0 (95% CI 64.2-77.9). This reduced to 46.1 (95% CI 37.2-55.0) after 1 day, 41.8 (95% CI 34.7 to 49.0) after 1 week and 13.5 (95% CI 5.8-21.3) after 26 weeks. The course of disability followed a similar pattern. CONCLUSIONS: Patients presenting to EDs with non-specific low back pain experience rapid reductions in pain intensity, but on average symptoms persisted 6 months later. This review can be used to educate patients so they can have realistic expectations of their recovery.

Emergency department interventions for adult patients with low back pain: a systematic review of randomised controlled trials.

BACKGROUND: Most low back pain trials have limited applicability to the emergency department (ED) because they provide treatment and measure outcomes after discharge from the ED. We investigated the efficacy and safety of pharmacological and non-pharmacological interventions delivered in the ED to patients with non-specific low back pain and/or sciatica on patient-relevant outcomes measured during the emergency visit. METHODS: Literature searches were performed in MEDLINE, EMBASE and CINAHL from inception to week 1 February 2020. We included all randomised controlled trials investigating adult patients (≥18 years) with non-specific low back pain and/or sciatica presenting to ED. The primary outcome of interest was pain intensity. Two reviewers independently screened the full texts, extracted the data and assessed risk of bias of each trial using the Physiotherapy Evidence Database (PEDro) scale. The overall quality of evidence, or certainty, provided by a set of trials evaluating the same treatment was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which considers imprecision, inconsistency, indirectness and bias in the evidence. RESULTS: Fifteen trials (1802 participants) were included with 12 of 15 at low risk of bias (ie, PEDro score >6). Based on results from individual trials and moderate quality evidence, ketoprofen gel was more effective than placebo for non-specific low back pain at 30 min (mean difference (MD) -15.0, 95% confidence interval (CI) -21.0 to -9.0). For those with sciatica (moderate quality evidence), intravenous paracetamol (acetaminophen) (MD -15.7, 95% CI -19.8 to -11.6) and intravenous morphine (MD -11.4, 95% CI -21.6 to -1.2) were both superior to placebo at 30 min. Based on moderate quality of evidence, corticosteroids showed no benefits against placebo at emergency discharge for non-specific low back pain (MD 9.0, 95% CI -0.71 to 18.7) or sciatica (MD -6.8, 95% CI -24.2 to 10.6). There were conflicting results from trials comparing different pharmacological options (moderate quality evidence) or investigating non-pharmacological treatments (low quality evidence). CONCLUSION: Ketoprofen gel for non-specific low back pain and intravenous paracetamol or morphine for sciatica were superior to placebo, whereas corticosteroids were ineffective for both conditions. There was conflicting evidence for comparisons of different pharmacological options and those involving non-pharmacological treatments. Additional trials measuring important patient-related outcomes to EDs are needed.

Paracetamol versus placebo for knee and hip osteoarthritis.

BACKGROUND: Paracetamol (acetaminophen) is vastly recommended as the first-line analgesic for osteoarthritis of the hip or knee. However, there has been controversy about this recommendation given recent studies have revealed small effects of paracetamol when compared with placebo. Nonetheless, past studies have not systematically reviewed and appraised the literature to investigate the effects of this drug on specific osteoarthritis sites, that is, hip or knee, or on the dose used. OBJECTIVES: To assess the benefits and harms of paracetamol compared with placebo in the treatment of osteoarthritis of the hip or knee. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, AMED, CINAHL, Web of Science, LILACS, and International Pharmaceutical Abstracts to 3 October 2017, and ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (ICTRP) portal on 20 October 2017. SELECTION CRITERIA: We included randomised controlled trials comparing paracetamol with placebo in adults with osteoarthritis of the hip or knee. Major outcomes were pain, function, quality of life, adverse events and withdrawals due to adverse events, serious adverse events, and abnormal liver function tests. DATA COLLECTION AND ANALYSIS: Two review authors used standard Cochrane methods to collect data, and assess risk of bias and quality of the evidence. For pooling purposes, we converted pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index function) scores to a common 0 (no pain or disability) to 100 (worst possible pain or disability) scale. MAIN RESULTS: We identified 10 randomised placebo-controlled trials involving 3541 participants with hip or knee osteoarthritis. The paracetamol dose varied from 1.95 g/day to 4 g/day, and the majority of trials followed participants for three months only. Most trials did not clearly report randomisation and concealment methods and were at unclear risk of selection bias. Trials were at low risk of performance, detection, and reporting bias.At 3 weeks' to 3 months' follow-up, there was high-quality evidence that paracetamol provided no clinically important improvements in pain and physical function. Mean reduction in pain was 23 points (0 to 100 scale, lower scores indicated less pain) with placebo and 3.23 points better (5.43 better to 1.02 better) with paracetamol, an absolute reduction of 3% (1% better to 5% better, minimal clinical important difference 9%) and relative reduction of 5% (2% better to 8% better) (seven trials, 2355 participants). Physical function improved by 12 points on a 0 to 100 scale (lower scores indicated better function) with placebo and was 2.9 points better (0.95 better to 4.89 better) with paracetamol, an absolute improvement of 3% (1% better to 5% better, minimal clinical important difference 10%) and relative improvement of 5% (2% better to 9% better) (7 trials, 2354 participants).High-quality evidence from eight trials indicated that the incidence of adverse events was similar between groups: 515/1586 (325 per 1000) in the placebo group versus 537/1666 (328 per 1000, range 299 to 360) in the paracetamol group (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.92 to 1.11). There was less certainty (moderate-quality evidence) around the risk of serious adverse events, withdrawals due to adverse events, and the rate of abnormal liver function tests, due to wide CIs or small event rates, indicating imprecision. Seventeen of 1480 (11 per 1000) people treated with placebo and 28/1729 (16 per 1000, range 8 to 29) people treated with paracetamol experienced serious adverse events (RR 1.36, 95% CI 0.73 to 2.53; 6 trials). The incidence of withdrawals due to adverse events was 65/1000 participants in with placebo and 77/1000 (range 59 to 100) participants with paracetamol (RR 1.19, 95% CI 0.91 to 1.55; 7 trials). Abnormal liver function occurred in 18/1000 participants treated with placebo and 70/1000 participants treated with paracetamol (RR 3.79, 95% CI 1.94 to 7.39), but the clinical importance of this effect was uncertain. None of the trials reported quality of life.Subgroup analyses indicated that the effects of paracetamol on pain and function did not differ according to the dose of paracetamol (3.0 g/day or less versus 3.9 g/day or greater). AUTHORS' CONCLUSIONS: Based on high-quality evidence this review confirms that paracetamol provides only minimal improvements in pain and function for people with hip or knee osteoarthritis, with no increased risk of adverse events overall. Subgroup analysis indicates that the effects on pain and function do not differ according to the dose of paracetamol. Due to the small number of events, we are less certain if paracetamol use increases the risk of serious adverse events, withdrawals due to adverse events, and rate of abnormal liver function tests.Current clinical guidelines consistently recommend paracetamol as the first-line analgesic medication for hip or knee osteoarthritis, given its low absolute frequency of substantive harm. However, our results call for reconsideration of these recommendations.

Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis.

OBJECTIVE: To investigate the efficacy and safety of dietary supplements for patients with osteoarthritis. DESIGN: An intervention systematic review with random effects meta-analysis and meta-regression. DATA SOURCES: MEDLINE, EMBASE, Cochrane Register of Controlled Trials, Allied and Complementary Medicine and Cumulative Index to Nursing and Allied Health Literature were searched from inception to April 2017. STUDY ELIGIBILITY CRITERIA: Randomised controlled trials comparing oral supplements with placebo for hand, hip or knee osteoarthritis. RESULTS: Of 20 supplements investigated in 69 eligible studies, 7 (collagen hydrolysate, passion fruit peel extract, Curcuma longa extract, Boswellia serrata extract, curcumin, pycnogenol and L-carnitine) demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. Another six (undenatured type II collagen, avocado soybean unsaponifiables, methylsulfonylmethane, diacerein, glucosamine and chondroitin) revealed statistically significant improvements on pain, but were of unclear clinical importance. Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. No supplements were identified with clinically important effects on pain reduction at long term. Similar results were found for physical function. Chondroitin demonstrated statistically significant, but not clinically important structural improvement (effect size -0.30, -0.42 to -0.17). There were no differences between supplements and placebo for safety outcomes, except for diacerein. The Grading of Recommendations Assessment, Development and Evaluation suggested a wide range of quality evidence from very low to high. CONCLUSIONS: The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low. Some supplements with a limited number of studies and participants suggested large treatment effects, while widely used supplements such as glucosamine and chondroitin were either ineffective or showed small and arguably clinically unimportant treatment effects. Supplements had no clinically important effects on pain and function at medium-term and long-term follow-ups.

Non-steroidal anti-inflammatory drugs for spinal pain: a systematic review and meta-analysis.

BACKGROUND: While it is now clear that paracetamol is ineffective for spinal pain, there is not consensus on the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) for this condition. We performed a systematic review with meta-analysis to determine the efficacy and safety of NSAIDs for spinal pain. METHODS: We searched MEDLINE, EMBASE, CINAHL, CENTRAL and LILACS for randomised controlled trials comparing the efficacy and safety of NSAIDs with placebo for spinal pain. Reviewers extracted data, assessed risk of bias and evaluated the quality of evidence using the Grade of Recommendations Assessment, Development and Evaluation approach. A between-group difference of 10 points (on a 0-100 scale) was used for pain and disability as the smallest worthwhile effect, as well as to calculate numbers needed to treat. Random-effects models were used to calculate mean differences or risk ratios with 95% CIs. RESULTS: We included 35 randomised placebo-controlled trials. NSAIDs reduced pain and disability, but provided clinically unimportant effects over placebo. Six participants (95% CI 4 to 10) needed to be treated with NSAIDs, rather than placebo, for one additional participant to achieve clinically important pain reduction. When looking at different types of spinal pain, outcomes or time points, in only 3 of the 14 analyses were the pooled treatment effects marginally above our threshold for clinical importance. NSAIDs increased the risk of gastrointestinal reactions by 2.5 times (95% CI 1.2 to 5.2), although the median duration of included trials was 7 days. CONCLUSIONS: NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo. There is an urgent need to develop new drug therapies for this condition.

Paracetamol for low back pain.

BACKGROUND: Analgesic medication is the most frequently prescribed treatment for low back pain (LBP), of which paracetamol (acetaminophen) is recommended as the first choice medication. However, there is uncertainty about the efficacy of paracetamol for LBP. OBJECTIVES: To investigate the efficacy and safety of paracetamol for non-specific LBP. SEARCH METHODS: We conducted searches on the Cochrane Central Register of Controlled Trials (CENTRAL, which includes the Back and Neck Review Group trials register), MEDLINE, EMBASE, CINAHL, AMED, Web of Science, LILACS, and IPA from their inception to 7 August 2015. We also searched the reference lists of eligible papers and trial registry websites (WHO ICTRP and ClinicalTrials.gov). SELECTION CRITERIA: We only considered randomised trials comparing the efficacy of paracetamol with placebo for non-specific LBP. The primary outcomes were pain and disability. We also investigated quality of life, function, adverse effects, global impression of recovery, sleep quality, patient adherence, and use of rescue medication as secondary outcomes. DATA COLLECTION AND ANALYSIS: Two review authors independently performed the data extraction and assessed risk of bias in the included studies. We also evaluated the quality of evidence using the GRADE approach. We converted scales for pain intensity to a common 0 to 100 scale. We quantified treatment effects using mean difference for continuous outcomes and risk ratios for dichotomous outcomes. We used effect sizes and 95% confidence intervals as a measure of treatment effect for the primary outcomes. When the treatment effects were smaller than 9 points on a 0 to 100 scale, we considered the effect as small and not clinically important. MAIN RESULTS: Our searches retrieved 4449 records, of which three trials were included in the review (n = 1825 participants), and two trials were included in the meta-analysis. For acute LBP, there is high-quality evidence for no difference between paracetamol (4 g per day) and placebo at 1 week (immediate term), 2 weeks, 4 weeks, and 12 weeks (short term) for the primary outcomes. There is high-quality evidence that paracetamol has no effect on quality of life, function, global impression of recovery, and sleep quality for all included time periods. There were also no significant differences between paracetamol and placebo for adverse events, patient adherence, or use of rescue medication. For chronic LBP, there is very low-quality evidence (based on a trial that has been retracted) for no effect of paracetamol (1 g single intravenous dose) on immediate pain reduction. Finally, no trials were identified evaluating patients with subacute LBP. AUTHORS' CONCLUSIONS: We found that paracetamol does not produce better outcomes than placebo for people with acute LBP, and it is uncertain if it has any effect on chronic LBP.

Surgical options for lumbar spinal stenosis.

BACKGROUND: Hospital charges for lumbar spinal stenosis have increased significantly worldwide in recent times, with great variation in the costs and rates of different surgical procedures. There have also been significant increases in the rate of complex fusion and the use of spinal spacer implants compared to that of traditional decompression surgery, even though the former is known to incur costs up to three times higher. Moreover, the superiority of these new surgical procedures over traditional decompression surgery is still unclear. OBJECTIVES: To determine the efficacy of surgery in the management of patients with symptomatic lumbar spinal stenosis and the comparative effectiveness between commonly performed surgical techniques to treat this condition on patient-related outcomes. We also aimed to investigate the safety of these surgical interventions by including perioperative surgical data and reoperation rates. SEARCH METHODS: Review authors performed electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED, Web of Science, LILACS and three trials registries from their inception to 16 June 2016. Authors also conducted citation tracking on the reference lists of included trials and relevant systematic reviews. SELECTION CRITERIA: This review included only randomised controlled trials that investigated the efficacy and safety of surgery compared with no treatment, placebo or sham surgery, or with another surgical technique in patients with lumbar spinal stenosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the studies for inclusion and performed the 'Risk of bias' assessment, using the Cochrane Back and Neck Review Group criteria. Reviewers also extracted demographics, surgery details, and types of outcomes to describe the characteristics of included studies. Primary outcomes were pain intensity, physical function or disability status, quality of life, and recovery. The secondary outcomes included measurements related to surgery, such as perioperative blood loss, operation time, length of hospital stay, reoperation rates, and costs. We grouped trials according to the types of surgical interventions being compared and categorised follow-up times as short-term when less than 12 months and long-term when 12 months or more. Pain and disability scores were converted to a common 0 to 100 scale. We calculated mean differences for continuous outcomes and relative risks for dichotomous outcomes. We pooled data using the random-effects model in Review Manager 5.3, and used the GRADE approach to assess the quality of the evidence. MAIN RESULTS: We included a total of 24 randomised controlled trials (reported in 39 published research articles or abstracts) in this review. The trials included 2352 participants with lumbar spinal stenosis with symptoms of neurogenic claudication. None of the included trials compared surgery with no treatment, placebo or sham surgery. Therefore, all included studies compared two or more surgical techniques. We judged all trials to be at high risk of bias for the blinding of care provider domain, and most of the trials failed to adequately conceal the randomisation process, blind the participants or use intention-to-treat analysis. Five trials compared the effects of fusion in addition to decompression surgery. Our results showed no significant differences in pain relief at long-term (mean difference (MD) -0.29, 95% confidence interval (CI) -7.32 to 6.74). Similarly, we found no between-group differences in disability reduction in the long-term (MD 3.26, 95% CI -6.12 to 12.63). Participants who received decompression alone had significantly less perioperative blood loss (MD -0.52 L, 95% CI -0.70 L to -0.34 L) and required shorter operations (MD -107.94 minutes, 95% CI -161.65 minutes to -54.23 minutes) compared with those treated with decompression plus fusion, though we found no difference in the number of reoperations (risk ratio (RR) 1.25, 95% CI 0.81 to 1.92). Another three trials investigated the effects of interspinous process spacer devices compared with conventional bony decompression. These spacer devices resulted in similar reductions in pain (MD -0.55, 95% CI -8.08 to 6.99) and disability (MD 1.25, 95% CI -4.48 to 6.98). The spacer devices required longer operation time (MD 39.11 minutes, 95% CI 19.43 minutes to 58.78 minutes) and were associated with higher risk of reoperation (RR 3.95, 95% CI 2.12 to 7.37), but we found no difference in perioperative blood loss (MD 144.00 mL, 95% CI -209.74 mL to 497.74 mL). Two trials compared interspinous spacer devices with decompression plus fusion. Although we found no difference in pain relief (MD 5.35, 95% CI -1.18 to 11.88), the spacer devices revealed a small but significant effect in disability reduction (MD 5.72, 95% CI 1.28 to 10.15). They were also superior to decompression plus fusion in terms of operation time (MD 78.91 minutes, 95% CI 30.16 minutes to 127.65 minutes) and perioperative blood loss (MD 238.90 mL, 95% CI 182.66 mL to 295.14 mL), however, there was no difference in rate of reoperation (RR 0.70, 95% CI 0.32 to 1.51). Overall there were no differences for the primary or secondary outcomes when different types of surgical decompression techniques were compared among each other. The quality of evidence varied from 'very low quality' to 'high quality'. AUTHORS' CONCLUSIONS: The results of this Cochrane review show a paucity of evidence on the efficacy of surgery for lumbar spinal stenosis, as to date no trials have compared surgery with no treatment, placebo or sham surgery. Placebo-controlled trials in surgery are feasible and needed in the field of lumbar spinal stenosis. Our results demonstrate that at present, decompression plus fusion and interspinous process spacers have not been shown to be superior to conventional decompression alone. More methodologically rigorous studies are needed in this field to confirm our results.

The efficacy of conservative treatment of osteoporotic compression fractures on acute pain relief: a systematic review with meta-analysis.

PURPOSE: The aim of this study is to systematically evaluate the efficacy of commonly used non-surgical treatments in acute care of adults with osteoporotic vertebral compression fractures (VCFs). METHODS: A systematic approach was used to search eight electronic databases for randomized controlled trials (RCTs) examining analgesic medications, passive physical therapies, bed rest or orthoses. Data on pain, activity/participation and adverse events were extracted. Methodological quality and quality of evidence were assessed with the Physiotherapy Evidence Database (PEDro) scale (score range 0-10) and the GRADE criteria, respectively. RESULTS: Five RCTs (total n = 350) were identified including one placebo-controlled and four controlled trials examining analgesics (2 studies) and orthoses (3). PEDro scores ranged from 4 to 7. The overall quality of evidence ranged from very low to low. In two trials, spinal orthoses provided significantly higher medium-term pain relief [pooled standardized mean differences (SMD): -1.47, 95 % confidence interval (CI) -1.82, -1.13; I (2) = 0 %] and disability reduction (pooled SMD: -1.73, 95 % CI -2.09, -1.37; I (2) = 0 %) than no intervention. Immediate- and short-term pain effects of diclofenac (a non-steroidal anti-inflammatory drug) and tramadol (a strong opioid) were demonstrated when compared to a Chinese medicine, whereas non-significant effects were found for oxycodone and tapentadol (strong opioids) in a placebo-controlled trial. Low/insufficient statistical power, co-interventions and potential conflict of interest might have influenced the results. CONCLUSIONS: At present, there is insufficient evidence to inform conservative care for acute pain related to VCF. Large, multinational, placebo/sham-controlled trials to address this gap in evidence are needed.