Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial.

BACKGROUND: Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain. METHODS: WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112). FINDINGS: Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60-0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149-295) in the intervention group and 112 days (89-140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group). INTERPRETATION: An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed. FUNDING: National Health and Medical Research Council, Australia.

The association between physical intervention use and treatment outcomes in patients participating in an online and psychologically informed pain management program.

BACKGROUND: The availability of multidisciplinary care for the management of chronic pain is uncommon outside specialist clinics. The current study aims to determine the physical intervention use of patients participating in an online psychological pain management program and whether exposure to physical interventions in these patients alters treatment outcomes compared to patients who do not access physical interventions. METHODS: Data were obtained from two previously published randomised control trials of an online psychological pain management program. Physical intervention exposure (category: None, 1-3, 4+ sessions) was assessed at baseline, post-treatment and at 3-month follow-up. Primary outcomes included depression, anxiety, pain intensity and pain-related disability. Generalised estimating equation models were used to compare treatment outcomes between those with different physical intervention frequencies and period of exposure. We assessed whether changes in primary outcomes differed (moderated) depending on the period and category of physical intervention exposure. RESULTS: N = 1,074 patients completed the baseline questionnaire across both RCTs, of whom 470 (44%) reported physical intervention use at baseline, 383 (38%) at post-treatment and 363 (42%) at 3-month follow-up. On average, there were moderate-large reductions from baseline to post-treatment with respect to all outcomes (Cohen's d = 0.36-0.82). In all outcomes, the interaction of time by physical intervention exposure was statistically non-significant. CONCLUSION: A substantial proportion of patients who participated in a psychologically informed pain management program were establishing, continuing, or stopping additional physical interventions. The frequency and period of exposure to physical interventions did not appear moderate treatment outcomes.

A Decision Aid for Patients Considering Surgery for Sciatica: Codesign and User-Testing With Patients and Clinicians.

BACKGROUND: Surgery can help patients with leg pain caused by sciatica recover faster, but by 12 months outcomes are similar to nonsurgical management. For many the decision to have surgery may require reflection, and patient decision aids are an evidence-based clinical tool that can help guide patients through this decision. OBJECTIVE: The aim of this study was to develop and refine a decision aid for patients with sciatica who are deciding whether to have surgery or 'wait and see' (i.e., try nonsurgical management first). DESIGN: Semistructured interviews with think-aloud user-testing protocol. PARTICIPANTS: Twenty clinicians and 20 patients with lived experience of low back pain or sciatica. OUTCOME MEASURES: Items from Technology Acceptance Model, Preparation for Decision Making Scale and Decision Quality Instrument for Herniated Disc 2.0 (knowledge instrument). METHODS: The prototype integrated relevant research with working group perspectives, decision aid standards and health literacy guidelines. The research team refined the prototype through seven rounds of user-testing, which involved discussing user-testing feedback and implementing changes before progressing to the next round. RESULTS: As a result of working group feedback, the decision aid was divided into sections: before, during and after a visit to the surgeon. Across all rounds of user-testing, clinicians rated the resource 5.9/7 (SD = 1.0) for perceived usefulness, and 6.0/7 for perceived ease of use (SD = 0.8). Patients reported the decision aid was easy to understand, on average correctly answering 3.4/5 knowledge questions (SD = 1.2) about surgery for sciatica. The grade reading score for the website was 9.0. Patients scored highly on preparation for decision-making (4.4/5, SD = 0.7), suggesting strong potential to empower patients. Interview feedback showed that patients and clinicians felt the decision aid would encourage question-asking and help patients reflect on personal values. CONCLUSIONS: Clinicians found the decision aid acceptable, patients found it was easy to understand and both groups felt it would empower patients to actively engage in their care and come to an informed decision that aligned with personal values. Input from the working group and user-testing was crucial for ensuring that the decision aid met patient and clinician needs. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians contributed to prototype development via the working group.

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.

Healthcare expenditure and its predictors in a cohort of Australians living with sciatica.

PURPOSE: To estimate the healthcare resource utilisation of an Australian cohort of people with sciatica and explore individual-level factors associated with expenditure. METHODS: Healthcare utilisation (services and medication) data from a randomised, double-blind, placebo-controlled trial of pregabalin in patients with sciatica (n = 185) were analysed to estimate healthcare expenditure of participants over 12 months. Associations between key baseline socio-economic, pain and quality of life characteristics and healthcare expenditure were examined using generalised linear imputation models. RESULTS: On average, participants accessed AUD$1,134 of healthcare over the year, predominantly made up of $114 of medication and $914 of health services, which included $418 of physiotherapy services. Participants randomised to receive pregabalin incurred higher expenditure ($1,263 compared to $1,001 for placebo), which was largely driven by pregabalin ($158) and greater health services ($107). Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental). CONCLUSION: Our results suggest inefficiency in the use of healthcare resources due to increased healthcare resource utilisation in people with sciatica treated with pregabalin, compared to placebo. Costs of treating sciatica varied based on individual quality of life and socio-economic characteristics.

Patient education booklet to support evidence-based low back pain care in primary care - a cluster randomized controlled trial.

BACKGROUND: Inappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care. METHODS: A cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes. RESULTS: Using the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004). CONCLUSIONS: The booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group. TRIAL REGISTRATION: ISRCTN, ISRCTN14389368 , Registered 4 April 2019-Retrospectively registered.

Prevention strategies to reduce future impact of low back pain: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the evidence from randomised controlled trials (RCTs) on the effectiveness of prevention strategies to reduce future impact of low back pain (LBP), where impact is measured by LBP intensity and associated disability. DESIGN: Systematic review with meta-analysis. DATA SOURCES: MEDLINE, Embase, CINAHL, PEDro and The Cochrane (CENTRAL) databases from inception to 22 October 2018. ELIGIBILITY CRITERIA: RCTs evaluating any intervention aiming to prevent future impact of LBP, reporting an outcome measure of LBP intensity and/or disability measured at least 3 months post-randomisation, and the intervention group must be compared with a group that received no intervention/placebo or minimal intervention. Trials restricting recruitment to participants with current LBP were excluded. RESULTS: 27 published reports of 25 different trials including a total of 8341 participants fulfilled the inclusion criteria. The pooled results, from three RCTs (612 participants), found moderate-quality evidence that an exercise programme can prevent future LBP intensity (mean difference (MD) -4.50; 95% CI -7.26 to -1.74), and from 4 RCTs (471 participants) that an exercise and education programme can prevent future disability due to LBP (MD -6.28; 95% CI -9.51 to -3.06). It is uncertain whether prevention programmes improve future quality of life (QoL) and workability due to the overall low-quality and very low-quality available evidence. CONCLUSIONS: This review provides moderate-quality evidence that an exercise programme, and a programme combining exercise and education, are effective to reduce future LBP intensity and associated disability. It is uncertain whether prevention programmes can improve future QoL and workability. Further high-quality RCTs evaluating prevention programmes aiming to reduce future impact of LBP are needed.

Clinical Course of Pain and Function Following Total Knee Arthroplasty: A Systematic Review and Meta-Regression.

BACKGROUND: Total knee arthroplasty (TKA) is widely considered a successful intervention for osteoarthritis and other degenerative knee diseases. This study addresses the need for a high-quality meta-analysis that outlines the clinical course of pain and function post-TKA. METHODS: The review included prospective cohort studies assessing pain or function of patients undergoing primary TKA at baseline (preoperatively) and at least 2 additional time points including one at least 12 months postoperatively. Two reviewers independently screened references, extracted data, and assessed risk of bias using the Quality in Prognosis Studies tool. The time course of recovery of pain and function was modeled using fractional polynomial meta-regression. RESULTS: In total, 191 studies with 59,667 patients were included, most with low risk of bias. The variance-weighted mean pain score (/100, 0 = no pain) was 64.0 (95% confidence interval [CI] 60.2-67.7) preoperatively, 24.1 (95% CI 20.3-27.9) at 3 months, 20.4 (95% CI 16.7-24.0) at 6 months, and 16.9 (95%CI 13.6-20.3) at 12 months, and remained low (10.1; 95% CI 4.8-15.4) at 10 years postoperatively. The variance-weighted mean function score (/100, 0 = worst function) was 47.1 (95% CI 45.7-48.4) preoperatively, 72.8 (95% CI 71.3-74.4) at 3 months, 76.3 (95% CI 74.7-77.8) at 6 months, and 78.1 (95%CI 76.4-79.7) at 12 months. Function scores were good (79.7; 95% CI 77.9-81.5) at 10 years postoperatively. CONCLUSION: Patients undergoing primary TKA can expect a large and rapid but incomplete recovery of pain and function in the first postoperative year. At 10 years, the gains in pain scores may still remain while there is an improvement in function.

Trial of Pregabalin for Acute and Chronic Sciatica.

BACKGROUND: Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. RESULTS: A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in the placebo group (adjusted mean difference, 0.3; 95% CI, -0.5 to 1.0; P=0.46). No significant between-group differences were observed with respect to any secondary outcome at either week 8 or week 52. A total of 227 adverse events were reported in the pregabalin group and 124 in the placebo group. Dizziness was more common in the pregabalin group than in the placebo group. CONCLUSIONS: Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group. (Funded by the National Health and Medical Research Council of Australia; PRECISE Australian and New Zealand Clinical Trials Registry number, ACTRN12613000530729 .).

Epidural corticosteroid injections for lumbosacral radicular pain.

BACKGROUND: Lumbosacral radicular pain (commonly called sciatica) is a syndrome involving patients who report radiating leg pain. Epidural corticosteroid injections deliver a corticosteroid dose into the epidural space, with the aim of reducing the local inflammatory process and, consequently, relieving the symptoms of lumbosacral radicular pain. This Cochrane Review is an update of a review published in Annals of Internal Medicine in 2012. Some placebo-controlled trials have been published recently, which highlights the importance of updating the previous review. OBJECTIVES: To investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection on pain and disability in patients with lumbosacral radicular pain. SEARCH METHODS: We searched the following databases without language limitations up to 25 September 2019: Cochrane Back and Neck group trial register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and two trial registers. We also performed citation tracking of included studies and relevant systematic reviews in the field. SELECTION CRITERIA: We included studies that compared epidural corticosteroid injections of any corticosteroid drug to placebo injections in patients with lumbosacral radicular pain. We accepted all three anatomical approaches (caudal, interlaminar, and transforaminal) to delivering corticosteroids into the epidural space. We considered trials that included a placebo treatment as delivery of an inert substance (i.e. one with no pharmacologic activity), an innocuous substance (e.g. normal saline solution), or a pharmacologically active substance but not one considered to provide sustained benefit (e.g. local anaesthetic), either into the epidural space (i.e. to mimic epidural corticosteroid injection) or adjacent spinal tissue (i.e. subcutaneous, intramuscular, or interspinous tissue). We also included trials in which a local anaesthetic with a short duration of action was used as a placebo and injected together with corticosteroid in the intervention group. DATA COLLECTION AND ANALYSIS: Two authors independently performed the screening, data extraction, and 'Risk of bias' assessments. In case of insufficient information, we contacted the authors of the original studies or estimated the data. We grouped the outcome data into four time points of assessment: immediate (≤ 2 weeks), short term (> 2 weeks but ≤ 3 months), intermediate term (> 3 months but < 12 months), and long term (≥ 12 months). We assessed the overall quality of evidence for each outcome and time point using the GRADE approach. MAIN RESULTS: We included 25 clinical trials (from 29 publications) investigating the effects of epidural corticosteroid injections compared to placebo in patients with lumbosacral radicular pain. The included studies provided data for a total of 2470 participants with a mean age ranging from 37.3 to 52.8 years. Seventeen studies included participants with lumbosacral radicular pain with a diagnosis based on clinical assessment and 15 studies included participants with mixed duration of symptoms. The included studies were conducted mainly in North America and Europe. Fifteen studies did not report funding sources, five studies reported not receiving funding, and five reported receiving funding from a non-profit or government source. Eight trials reported data on pain intensity, 12 reported data on disability, and eight studies reported data on adverse events. The duration of the follow-up assessments ranged from 12 hours to 1 year. We considered eight trials to be of high quality because we judged them as having low risk of bias in four out of the five bias domains. We identified one ongoing trial in a trial registry. Epidural corticosteroid injections were probably slightly more effective compared to placebo in reducing leg pain at short-term follow-up (mean difference (MD) -4.93, 95% confidence interval (CI) -8.77 to -1.09 on a 0 to 100 scale; 8 trials, n = 949; moderate-quality evidence (downgraded for risk of bias)). For disability, epidural corticosteroid injections were probably slightly more effective compared to placebo in reducing disability at short-term follow-up (MD -4.18, 95% CI -6.04 to -2.17, on a 0 to 100 scale; 12 trials, n = 1367; moderate-quality evidence (downgraded for risk of bias)). The treatment effects are small, however, and may not be considered clinically important by patients and clinicians (i.e. MD lower than 10%). Most trials provided insufficient information on how or when adverse events were assessed (immediate or short-term follow-up) and only reported adverse drug reactions - that is, adverse events that the trialists attributed to the study treatment. We are very uncertain that epidural corticosteroid injections make no difference compared to placebo injection in the frequency of minor adverse events (risk ratio (RR) 1.14, 95% CI 0.91 to 1.42; 8 trials, n = 877; very low quality evidence (downgraded for risk of bias, inconsistency and imprecision)). Minor adverse events included increased pain during or after the injection, non-specific headache, post-dural puncture headache, irregular periods, accidental dural puncture, thoracic pain, non-local rash, sinusitis, vasovagal response, hypotension, nausea, and tinnitus. One study reported a major drug reaction for one patient on anticoagulant therapy who had a retroperitoneal haematoma as a complication of the corticosteroid injection. AUTHORS' CONCLUSIONS: This study found that epidural corticosteroid injections probably slightly reduced leg pain and disability at short-term follow-up in people with lumbosacral radicular pain. In addition, no minor or major adverse events were reported at short-term follow-up after epidural corticosteroid injections or placebo injection. Although the current review identified additional clinical trials, the available evidence still provides only limited support for the use of epidural corticosteroid injections in people with lumbosacral radicular pain as the treatment effects are small, mainly evident at short-term follow-up and may not be considered clinically important by patients and clinicians (i.e. mean difference lower than 10%). According to GRADE, the quality of the evidence ranged from very low to moderate, suggesting that further studies are likely to play an important role in clarifying the efficacy and tolerability of this treatment. We recommend that further trials should attend to methodological features such as appropriate allocation concealment and blinding of care providers to minimise the potential for biased estimates of treatment and harmful effects.

What low back pain is and why we need to pay attention.

Low back pain is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population. Globally, years lived with disability caused by low back pain increased by 54% between 1990 and 2015, mainly because of population increase and ageing, with the biggest increase seen in low-income and middle-income countries. Low back pain is now the leading cause of disability worldwide. For nearly all people with low back pain, it is not possible to identify a specific nociceptive cause. Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain. Disabling low back pain is over-represented among people with low socioeconomic status. Most people with new episodes of low back pain recover quickly; however, recurrence is common and in a small proportion of people, low back pain becomes persistent and disabling. Initial high pain intensity, psychological distress, and accompanying pain at multiple body sites increases the risk of persistent disabling low back pain. Increasing evidence shows that central pain-modulating mechanisms and pain cognitions have important roles in the development of persistent disabling low back pain. Cost, health-care use, and disability from low back pain vary substantially between countries and are influenced by local culture and social systems, as well as by beliefs about cause and effect. Disability and costs attributed to low back pain are projected to increase in coming decades, in particular in low-income and middle-income countries, where health and other systems are often fragile and not equipped to cope with this growing burden. Intensified research efforts and global initiatives are clearly needed to address the burden of low back pain as a public health problem.

Cervical spine findings on MRI in people with neck pain compared with pain-free controls: A systematic review and meta-analysis.

BACKGROUND: There is uncertainty regarding the clinical significance of findings on MRI in patients with whiplash associated disorder (WAD) or nonspecific neck pain (NSNP). PURPOSE: To compare the presence of cervical spine MRI findings in people with WAD or NSNP with pain-free controls. STUDY TYPE: Systematic review and meta-analysis. POPULATION: Adults with WAD (n = 994), NSNP (n = 715), or pain-free controls (n = 2323). FIELD STRENGTH: 0.5T, 1.5T, and 3.0T. ASSESSMENT: Medline, EMBASE, CINAHL, Web of Science, SCOPUS, and Cochrane CENTRAL databases were searched. Two independent reviewers identified studies for inclusion and extracted data. Risk of bias was assessed using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. Overall quality of the evidence from meta-analysis was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation approach. STATISTICAL TESTS: Meta-analysis was performed using a random-effects model to calculate odds ratios or standard mean differences (SMDs) for binary and continuous data. RESULTS: In total, 31 studies were included (eight comparing acute WAD to controls, 14 comparing chronic WAD to controls, 12 comparing chronic NSNP to controls) comprising 4032 participants. Rectus capitis posterior major cross-sectional area was smaller in people with chronic NSNP than controls (two studies: SMD -1.18 [95% confidence interval [CI] -1.65, -0.71]). The remaining meta-analysis comparisons showed no group differences in MRI findings. The quality of evidence was mostly low due to small sample sizes and high heterogeneity. DATA CONCLUSION: Given the typically low-quality evidence, definitive conclusions cannot be drawn on the presence of MRI findings in individuals with WAD or NSNP compared with pain-free controls. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 3 J. Magn. Reson. Imaging 2018.

Transcultural adaption and preliminary evaluation of "understanding low back pain" patient education booklet.

BACKGROUND: Low back pain (LBP) is the number one cause of disability globally. LBP is a symptom associated with biological, psychological and social factors, and serious causes for pain are very rare. Unhelpful beliefs about LBP and inappropriate imaging are common. Practitioners report pressure from patients to provide inappropriate imaging. A recently developed patient education and management booklet, 'Understanding low back pain', was designed to target previously identified barriers for reducing inappropriate imaging. The booklet includes evidence-based information on LBP and supports communication between patients and practitioners. Our aim was to 1) describe the translation process into Finnish and 2) study patients' and practitioners' attitudes to the booklet and to evaluate if it improved patients' understanding of LBP and practitioners' ability to follow imaging guidelines. METHODS: We translated the booklet from English to Finnish. Preliminary evaluation of the booklet was obtained from LBP patients (n = 136) and practitioners (n = 32) using web-based questionnaires. Open-ended questions were analysed using thematic analysis. RESULTS: Approximately half of the patients reported that reading the booklet helped them to understand LBP, while a third thought it encouraged them to perform physical activity and decreased LBP-related fear. Eighty percent of practitioners reported that the booklet helped them to follow imaging guidelines. In addition, practitioners reported that they found the booklet helpful and that it decreased the need for imaging. CONCLUSIONS: The booklet seemed to be helpful in LBP management and in decreasing the need for LBP imaging according to patients and practitioners. Further research on the clinical effectiveness of the booklet in controlled study settings is needed. TRIAL REGISTRATION: ISRCTN, ISRCTN14389368, Registered 4 April 2019 - Retrospectively registered; ISRCTN11875357, Registered 22 April 2019 - Retrospectively registered.

Evaluation of guideline-endorsed red flags to screen for fracture in patients presenting with low back pain.

OBJECTIVES: (1) Describe the evolution of guideline-endorsed red flags for fracture in patients presenting with low back pain; (2) evaluate agreement between guidelines; and (3) evaluate the extent to which recommendations are accompanied by information on diagnostic accuracy of endorsed red flags. DESIGN: Systematic review. DATA SOURCES: MEDLINE and PubMed, PEDro, CINAHL and EMBASE electronic databases. We also searched in guideline databases, including the National Guideline Clearinghouse and Canadian Medical Association Infobase. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Evidence-based clinical practice guidelines. DATA EXTRACTION: Two review authors independently extracted the following data: health professional association or society producing guideline, year of publication, the precise wording of endorsed red flag for vertebral fracture, recommendations for diagnostic workup if fracture is suspected, if the guidelines substantiate the recommendation with citation to a primary diagnostic study or diagnostic review, if the guideline provides any diagnostic accuracy data. RESULTS: 78 guidelines from 28 countries were included. A total of 12 discrete red flags were reported. The most commonly recommended red flags were older age, use of steroids, trauma and osteoporosis. Regarding the evolution of red flags, older age, trauma and osteoporosis were the first red flags endorsed (in 1994); and previous fracture was the last red flag endorsed (in 2003). Agreement between guidelines in endorsing red flags was only fair; kappa=0.32. Only 9 of the 78 guidelines substantiated their red flag recommendations by research and only nine provided information on diagnostic accuracy. SUMMARY/CONCLUSION: The number of red flags endorsed in guidelines to screen for fracture has risen over time; most guidelines do not endorse the same set of red flags and most recommendations are not supported by research or accompanied by diagnostic accuracy data.

Which Patients With Chronic Pain Are More Likely to Improve Pain Biology Knowledge Following Education?

BACKGROUND: Pain education is an important part of multidisciplinary management of chronic pain. The characteristics of people likely to have more improvement in pain biology knowledge following pain education are unknown. OBJECTIVE: To identify the baseline factors predicting changes in pain biology knowledge in adults with chronic pain following a 2-hour multidisciplinary pain education session. METHODS: Fifty-five adults with chronic pain attended a 2-hour pain education session prior to a multidisciplinary assessment at a pain clinic. Patients completed the 12-item revised Neurophysiology of Pain Questionnaire (rNPQ, score/12) before and after the pain education session. The primary outcome was change in pain biology knowledge, evaluated with the change in rNPQ score. Ten preselected predictors were investigated using univariate models followed by multivariable models with a manual forwards-building process. RESULTS: Education level and age were significantly associated with change in rNPQ score in the univariate models. Participants with higher levels of education had, on average, 1.96 (0.68 to 3.23) points more improvement in rNPQ score than those with lower levels of education. For every 10 years older a participant was, his or her rNPQ score changed on average by 0.5 (0.1 to 0.8) points less. In the multivariable model, only the education level remained significant, explaining 17% of the variance (R2  = 0.17). The clinical variables that were assessed (pain severity, pain interference, pain self-efficacy, depression, anxiety, and pain catastrophizing) did not predict any knowledge change. CONCLUSION: This study suggests that, of those patients with chronic pain who choose to attend pain education, more educated patients are more likely to improve their pain biology knowledge after a pain education session.

The economic burden of guideline-recommended first line care for acute low back pain.

PURPOSE: To report health care costs and the factors associated with such costs in people with acute low back pain receiving guideline-recommended first line care. METHODS: This is a secondary analysis of a trial which found no difference in clinical outcomes. Participants with acute low back pain received reassurance and advice, and either paracetamol (taken regularly or as needed) or placebo for up to 4 weeks and followed up for 12 weeks. Data on health service utilisation were collected by self-report. A health sector perspective was adopted to report all direct costs incurred (in 2015 AUD, 1 AUD = 0.53 Euro). Costs were reported for the entire study cohort and for each group. Various baseline clinical, demographic, work-related and socioeconomic factors were investigated for their association with increased costs using generalised linear models. RESULTS: The mean cost per participant was AUD167.74 (SD = 427.24) for the entire cohort (n = 1365). Most of these costs were incurred in primary care through visits to a general practitioner or physiotherapist. Compared to the placebo group, there was an increase in cost when paracetamol was taken. Multivariate analysis showed that disability, symptom duration and compensation were associated with costs. Receiving compensation was associated with a twofold increase compared to not receiving compensation. CONCLUSIONS: Taking paracetamol as part of first line care for acute low back pain increased the economic burden. Higher disability, longer symptom duration and receiving compensation were independently associated with increased health care costs.

Using behaviour change theory and preliminary testing to develop an implementation intervention to reduce imaging for low back pain.

BACKGROUND: Imaging is overused in the management of low back pain (LBP). Interventions designed to decrease non-indicated imaging have predominantly targeted practitioner education alone; however, these are typically ineffective. Barriers to reducing imaging have been identified for both patients and practitioners. Interventions aimed at addressing barriers in both these groups concurrently may be more effective. The Behaviour Change Wheel provides a structured framework for developing implementation interventions to facilitate behavioural change. The aim of this study was to develop an implementation intervention aiming to reduce non-indicated imaging for LBP, by targeting both general medical practitioner (GP) and patient barriers concurrently. METHODS: The Behaviour Change Wheel was used to identify the behaviours requiring change, and guide initial development of an implementation intervention. Preliminary testing of the intervention was performed with: 1) content review by experts in the field; and 2) qualitative analysis of semi-structured interviews with 10 GPs and 10 healthcare consumers, to determine barriers and facilitators to successful implementation of the intervention in clinical practice. Results informed further development of the implementation intervention. RESULTS: Patient pressure on the GP to order imaging, and the inability of the GP to manage a clinical consult for LBP without imaging, were determined to be the primary behaviours leading to referral for non-indicated imaging. The developed implementation intervention consisted of a purpose-developed clinical resource for GPs to use with patients during a LBP consult, and a GP training session. The implementation intervention was designed to provide GP and patient education, remind GPs of preferred behaviour, provide clinical decision support, and facilitate GP-patient communication. Preliminary testing found experts, GPs, and healthcare consumers were supportive of most aspects of the developed resource, and thought use would likely decrease non-indicated imaging for LBP. Suggestions for improvement of the implementation intervention were incorporated into a final version. CONCLUSIONS: The developed implementation intervention, aiming to reduce non-indicated imaging for LBP, was informed by behaviour change theory and preliminary testing. Further testing is required to assess feasibility of use in clinical practice, and the effectiveness of the implementation intervention in reducing imaging for LBP, before large-scale implementation can be considered.

McKenzie Method of Mechanical Diagnosis and Therapy was slightly more effective than placebo for pain, but not for disability, in patients with chronic non-specific low back pain: a randomised placebo controlled trial with short and longer term follow-up.

BACKGROUND: The McKenzie Method of Mechanical Diagnosis and Therapy (MDT) is one of the exercise approaches recommended by low back pain (LBP) guidelines. We investigated the efficacy of MDT compared with placebo in patients with chronic LBP. METHODS: This was a prospectively registered, two-arm randomised placebo controlled trial, with a blinded assessor. A total of 148 patients seeking care for chronic LBP were randomly allocated to either MDT (n=74) or placebo (n=74). Patients from both groups received 10 treatment sessions over 5 weeks. Patients from both groups also received an educational booklet. Clinical outcomes were obtained at the end of treatment (5 weeks) and 3, 6 and 12 months after randomisation. Primary outcomes were pain intensity and disability at the end of treatment (5 weeks). We also conducted a subgroup analysis to identify potential treatment effect modifiers that could predict a better response to MDT treatment. RESULTS: The MDT group had greater improvements in pain intensity at the end of treatment (mean difference (MD) -1.00, 95% CI -2.09 to -0.01) but not for disability (MD -0.84, 95% CI -2.62 to 0.93). We did not detect between-group differences for any secondary outcomes, nor were any treatment effect modifiers identified. Patients did not report any adverse events. CONCLUSION: We found a small and likely not clinically relevant difference in pain intensity favouring the MDT method immediately at the end of 5 weeks of treatment but not for disability. No other difference was found for any of the primary or secondary outcomes at any follow-up times. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02123394).

Acute Low Back Pain? Do Not Blame the Weather-A Case-Crossover Study.

Objective: To investigate the influence of various weather parameters on the risk of developing a low back pain (LBP) episode. Design: Case-crossover study. Setting: Primary care clinics in Sydney, Australia. Subjects: 981 participants with a new episode of acute LBP. Methods: Weather parameters were obtained from the Australian Bureau of Meteorology. Odds ratios (OR) and 95% confidence intervals (95% CI) were derived comparing two exposure variables in the case window-(1) the average of the weather variable for the day prior to pain onset and (2) the change in the weather variable from 2 days prior to 1 day prior to pain onset-with exposures in two control windows (1 week and 1 month before the case window). Results: The weather parameters of precipitation, humidity, wind speed, wind gust, wind direction, and air pressure were not associated with the onset of acute LBP. For one of the four analyses, higher temperature slightly increased the odds of pain onset. Conclusions: Common weather parameters that had been previously linked to musculoskeletal pain, such as precipitation, humidity, wind speed, wind gust, wind direction, and air pressure, do not increase the risk of onset for LBP.

Does weather affect daily pain intensity levels in patients with acute low back pain? A prospective cohort study.

The aim of this study was to investigate the influence of various weather parameters on pain intensity levels in patients with acute low back pain (LBP). We performed a secondary analysis using data from the PACE trial that evaluated paracetamol (acetaminophen) in the treatment of acute LBP. Data on 1604 patients with LBP were included in the analysis. Weather parameters (precipitation, temperature, relative humidity, and air pressure) were obtained from the Australian Bureau of Meteorology. Pain intensity was assessed daily on a 0-10 numerical pain rating scale over a 2-week period. A generalised estimating equation analysis was used to examine the relationship between daily pain intensity levels and weather in three different time epochs (current day, previous day, and change between previous and current days). A second model was adjusted for important back pain prognostic factors. The analysis did not show any association between weather and pain intensity levels in patients with acute LBP in each of the time epochs. There was no change in strength of association after the model was adjusted for prognostic factors. Contrary to common belief, the results demonstrated that the weather parameters of precipitation, temperature, relative humidity, and air pressure did not influence the intensity of pain reported by patients during an episode of acute LBP.