Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial.

BACKGROUND: Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce. We aimed to investigate the efficacy and safety of a judicious short course of an opioid analgesic for acute low back pain and neck pain. METHODS: OPAL was a triple-blinded, placebo-controlled randomised trial that recruited adults (aged ≥18 years) presenting to one of 157 primary care or emergency department sites in Sydney, NSW, Australia, with 12 weeks or less of low back or neck pain (or both) of at least moderate pain severity. Participants were randomly assigned (1:1) using statistician-generated randomly permuted blocks to guideline-recommended care plus an opioid (oxycodone-naloxone, up to 20 mg oxycodone per day orally) or guideline-recommended care and an identical placebo, for up to 6 weeks. The primary outcome was pain severity at 6 weeks measured with the pain severity subscale of the Brief Pain Inventory (10-point scale), analysed in all eligible participants who provided at least one post-randomisation pain score, by use of a repeated measures linear mixed model. Safety was analysed in all randomly assigned eligible participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000775516). FINDINGS: Between Feb 29, 2016, and March 10, 2022, 347 participants were recruited (174 to the opioid group and 173 to the placebo group). 170 (49%) of 346 participants were female and 176 (51%) were male. 33 (19%) of 174 participants in the opioid group and 25 (15%) of 172 in the placebo group had discontinued from the trial by week 6, due to loss to follow-up and participant withdrawals. 151 participants in the opioid group and 159 in the placebo group were included in the primary analysis. Mean pain score at 6 weeks was 2·78 (SE 0·20) in the opioid group versus 2·25 (0·19) in the placebo group (adjusted mean difference 0·53, 95% CI -0·00 to 1·07, p=0·051). 61 (35%) of 174 participants in the opioid group reported at least one adverse event versus 51 (30%) of 172 in the placebo group (p=0·30), but more people in the opioid group reported opioid-related adverse events (eg, 13 [7·5%] of 174 participants in the opioid group reported constipation vs six [3·5%] of 173 in the placebo group). INTERPRETATION: Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions. FUNDING: National Health and Medical Research Council, University of Sydney Faculty of Medicine and Health, and SafeWork SA.

Exercise Therapy for Treatment of Acute Non-specific Low Back Pain: A Cochrane Systematic Review and Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To assess the effectiveness of exercise for acute non-specific low back pain (LBP) vs our main comparisons: (1) sham treatment and (2) no treatment at short term (main follow-up time). DATA SOURCES AND STUDY SELECTION: A comprehensive search up till November 2021 was conducted in numerous databases for randomized controlled trials on the effectiveness of exercise in adults with acute LBP (<6 weeks). Studies examining LBP with a specific etiology were excluded. The primary outcomes were back pain, back-specific functional status, and recovery. DATA EXTRACTION: Two review authors independently conducted the study selection, risk of bias assessment, and data extraction. GRADE was used to assess the certainty of the evidence. DATA SYNTHESIS: We identified 23 randomized controlled trials (2674 participants). There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain (mean difference [MD] -0.80, 95% confidence interval [CI] -5.79 to 4.19; 1 study, 299 participants) and on functional status (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants) in the short term. There is very low-quality evidence which suggests no difference in effect on pain and functional status for exercise vs no treatment (2 studies; n=157, not pooled due to heterogeneity) at short-term follow-up. Similar results were found for the other follow-up moments. The certainty of the evidence was downgraded because many randomized controlled trials had a high risk of bias, were small in size, and/or there was substantial heterogeneity. CONCLUSION: Exercise therapy compared with sham/placebo and no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.

Does the intensity of pain and disability affect health-related quality of life of older adults with back pain? Multilevel analysis between Brazil and Netherlands: a cross-sectional study of the BACE consortium.

BACKGROUND: The prognosis of back pain (BP) in the older adults is less favorable than in younger adults and progress to adverse outcomes and consequent worsening of health-related quality of life (HRQoL). The present study aimed to verify the association between BP intensity, disability and HRQoL in older adults residents in Brazil and Netherlands, and to evaluate whether the country of residence influences the associations. METHODS: Data were collected from 602 Brazilian and 675 Dutch participants with a new episode of BP from the Back Complaints in Elders (BACE) consortium. For the present study, a cross section was used. Pain intensity and disability were assessed using the Numerical Rating Scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ), respectively. HRQoL was assessed using the Short Form Health Survey (SF-36) quality of life questionnaire. Age, sex, and education were descriptive variables. Pain intensity (NPS score) and country were the independent variables and quality of life assessed by each SF domain - 36 was the dependent variable. Analysis of models at the individual level was performed to verify the association between pain and disability, also HRQoL in Netherlands and Brazil in the total sample. The multilevel model was used to verify whether the older adults person's country of residence influenced this relationship. RESULTS: The average age of the participants was 67.00 (7.33) years. In the total sample, linear regression analysis adjusted for sex and age showed a significant association between BP intensity scores and HRQoL, for all domains. There was no association between disability and HRQoL. In the multilevel analysis, there was an association between BP intensity and HRQoL in all domains and an association between the country of residence and HRQoL, influencing the effect of pain, in all domains, except for the physical functioning. CONCLUSION: Socioeconomic and cultural aspects of different countries can affect the perception of the elderly about their HRQoL in the presence of BP. Pain and disability in Brazilian and Dutch older adults ones are experienced differently in relation to their HRQoL.

Association between clinical findings and the presence of lumbar spine osteoarthritis imaging features: A systematic review.

OBJECTIVE: Spinal osteoarthritis is difficult to study and diagnose, partly due to the lack of agreed diagnostic criteria. This systematic review aims to give an overview of the associations between clinical and imaging findings suggestive of spinal osteoarthritis in patients with low back pain to make a step towards agreed diagnostic criteria. DESIGN: We searched MEDLINE, Embase, Web of Science, and CINAHL from inception to April 29, 2021 to identify observational studies in adults that assessed the association between selected clinical and imaging findings suggestive of spinal osteoarthritis. Risk of bias was assessed using the Newcastle Ottawa Scale and the quality of evidence was graded using an adaptation of the GRADE approach. RESULTS: After screening 7902 studies, 30 met the inclusion criteria. High-quality evidence was found for the longitudinal association between low back pain (LBP) intensity, and both disc space narrowing and osteophytes, as well as for the association between LBP-related physical functioning and lumbar disc degeneration, the presence of spinal morning stiffness and disc space narrowing and for the lack of association between physical functioning and Schmorl's nodes. CONCLUSIONS: There is high- and moderate-quality evidence of associations between clinical and imaging findings suggestive of spinal osteoarthritis. However, the majority of the studied outcomes had low or very low-quality of evidence. Furthermore, clinical and methodological heterogeneity was a serious limitation, adding to the need and importance of agreed criteria for spinal osteoarthritis, which should be the scope of future research.

Exercise therapy for treatment of acute non-specific low back pain.

BACKGROUND: Low back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide. OBJECTIVES: To evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up. SEARCH METHODS: This is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004. SELECTION CRITERIA: We included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group. We downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants). There is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity. In two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy. AUTHORS' CONCLUSIONS: Exercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).

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

EDITORIAL NOTE: See https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD014461.pub2/full for a more recent review that covers this topic and has superseded this review. BACKGROUND: Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical examination is to identify patients with a higher likelihood of underlying serious pathology, such as vertebral fracture, who may require additional investigation and specific treatment. All 'evidence-based' clinical practice guidelines recommend the use of red flags to screen for serious causes of back pain. However, it remains unclear if the diagnostic accuracy of red flags is sufficient to support this recommendation. OBJECTIVES: To assess the diagnostic accuracy of red flags obtained in a clinical history or physical examination to screen for vertebral fracture in patients presenting with LBP. SEARCH METHODS: Electronic databases were searched for primary studies between the earliest date and 7 March 2012. Forward and backward citation searching of eligible studies was also conducted. SELECTION CRITERIA: Studies were considered if they compared the results of any aspect of the history or test conducted in the physical examination of patients presenting for LBP or examination of the lumbar spine, with a reference standard (diagnostic imaging). The selection criteria were independently applied by two review authors. DATA COLLECTION AND ANALYSIS: Three review authors independently conducted 'Risk of bias' assessment and data extraction. Risk of bias was assessed using the 11-item QUADAS tool. Characteristics of studies, patients, index tests and reference standards were extracted. Where available, raw data were used to calculate sensitivity and specificity with 95% confidence intervals (CI). Due to the heterogeneity of studies and tests, statistical pooling was not appropriate and the analysis for the review was descriptive only. Likelihood ratios for each test were calculated and used as an indication of clinical usefulness. MAIN RESULTS: Eight studies set in primary (four), secondary (one) and tertiary care (accident and emergency = three) were included in the review. Overall, the risk of bias of studies was moderate with high risk of selection and verification bias the predominant flaws. Reporting of index and reference tests was poor. The prevalence of vertebral fracture in accident and emergency settings ranged from 6.5% to 11% and in primary care from 0.7% to 4.5%. There were 29 groups of index tests investigated however, only two featured in more than two studies. Descriptive analyses revealed that three red flags in primary care were potentially useful with meaningful positive likelihood ratios (LR+) but mostly imprecise estimates (significant trauma, older age, corticosteroid use; LR+ point estimate ranging 3.42 to 12.85, 3.69 to 9.39, 3.97 to 48.50 respectively). One red flag in tertiary care appeared informative (contusion/abrasion; LR+ 31.09, 95% CI 18.25 to 52.96). The results of combined tests appeared more informative than individual red flags with LR+ estimates generally greater in magnitude and precision. AUTHORS' CONCLUSIONS: The available evidence does not support the use of many red flags to specifically screen for vertebral fracture in patients presenting for LBP. Based on evidence from single studies, few individual red flags appear informative as most have poor diagnostic accuracy as indicated by imprecise estimates of likelihood ratios. When combinations of red flags were used the performance appeared to improve. From the limited evidence, the findings give rise to a weak recommendation that a combination of a small subset of red flags may be useful to screen for vertebral fracture. It should also be noted that many red flags have high false positive rates; and if acted upon uncritically there would be consequences for the cost of management and outcomes of patients with LBP. Further research should focus on appropriate sets of red flags and adequate reporting of both index and reference tests.

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.

Determinants of dropout and compliance of children participating in a multidisciplinary intervention programme for overweight and obesity in socially deprived areas.

BACKGROUND: Children with overweight and obesity in socially deprived areas (SDAs) are less likely to complete and be compliant to a weight-loss programme. OBJECTIVES: To identify factors associated with dropout and compliance of a multidisciplinary weight-loss programme in SDA. METHODS: This prospective longitudinal cohort study included children (6-12 years) with overweight and obesity in a 12-week multidisciplinary intervention living in SDA in Rotterdam, the Netherlands. Potential predictive variables for dropout and compliance included were age, sex, the weight of the child and parents, quality of life, and referral status (self-registration or referral). A Cox proportional hazards model was performed to study the association between dropout and its potential predictive variables, whereas logistic regression analyses were used for the potential predictors for compliance. RESULTS: A total of 121 children started the intervention programme. Forty-one (33.9%) children dropped out and 68 (56.2%) were compliant with the intervention. The risk of dropping out of the intervention was significantly lower for a child with overweight parents than for those with parents with normal weight (adjusted hazard ratio [HR] 0.22 [95% confidence interval, CI 0.063-0.75]), and for those with parents with obesity (adjusted HR 0.18 [95% CI 0.060-0.52]). No other potential predictive variables were associated with dropout or compliance. CONCLUSION: Children from SDA participating in a weight-loss programme have a relatively high dropout and a low compliance rate. Parental weight seems to be an important predictor for dropout of children from SDA, where children with normal weight or obese parents have the highest risk of dropout compared with children of overweight parents.

Pragmatic Delphi study aimed at determining practical components for a tool designed to assist Dutch primary care-givers in opioid deprescribing for non-cancer pain.

BACKGROUND: Over the past decades, opioid prescriptions have increased in the Netherlands. The Dutch general practitioners' guideline on pain was recently updated and now aims to reduce opioid prescriptions and high-risk opioid use for non-cancer pain. The guideline, however, lacks practical measures for implementation. OBJECTIVE: This study aims to determine practical components for a tool that should assist Dutch primary care prescribers and implements the recently updated guideline to reduce opioid prescriptions and high-risk use. METHODS: A modified Delphi approach was used. The practical components for the tool were identified based on systematic reviews, qualitative studies, and Dutch primary care guidelines. Suggested components were divided into Part A, containing components designed to reduce opioid initiation and stimulate short-term use, and Part B, containing components designed to reduce opioid use among patients on long-term opioid treatment. During three rounds, a multidisciplinary panel of 21 experts assessed the content, usability, and feasibility of these components by adding, deleting, and adapting components until consensus was reached on the outlines of an opioid reduction tool. RESULTS: The resulting Part A consisted of six components, namely education, opioid decision tree, risk assessment, agreements on dosage and duration of use, guidance and follow-up, and interdisciplinary collaboration. The resulting Part B consisted of five components, namely education, patient identification, risk assessment, motivation, and tapering. CONCLUSIONS: In this pragmatic Delphi study, components for an opioid reduction tool for Dutch primary care-givers are identified. These components need further development, and the final tool should be tested in an implementation study.

The Effect of a New Payment System on Physiotherapeutic Management of Patients With Low Back Pain in Primary Care.

OBJECTIVE: To evaluate differences regarding the number of treatment sessions, costs, and outcomes (including relapses) between a regular payment-per-session system and the recently introduced product payment system in The Netherlands. DESIGN: Prospective cohort study. SETTING: Dutch physical therapy practices in primary care over a 2-year period. PARTICIPANTS: 16,103 patients with low back pain (LBP). INTERVENTION: The new product payment system is compared with the regular payment-per-session system. MAIN OUTCOME MEASURES: Pain, disability, recovery, number of physical therapy sessions, therapy duration, costs (per episode), and LBP relapse. RESULTS: At baseline, we found greater pain and disability scores associated with an increased risk profile in both payment systems. With regard to the payment systems, we found greater costs (€283.8 vs €210.8) and a greater percentage of relapse (4.5% vs 2.8%) for the product payment system compared with the payment-per-session system. Comparing the 2 payment systems within each risk strata, we found no significant differences, except for a decrease in pain in the medium-risk stratum. Concerning the therapy characteristics, we found that in the payment-per-session group, the therapy took 6 days longer for low-risk patients (median 27 vs 21 days) and 7 days shorter for high-risk patients (median 42 vs 49 days) compared with the product payment group. Moreover, the mean number of sessions in the payment-per-session group was greater for low-risk patients (5.4 vs 4.8 sessions) and lower for high-risk patients (7.7 vs 8.1 sessions) compared with the payment-per-session group. Finally, the costs were significantly greater in all strata of the product payment group compared with the payment-per-session group. CONCLUSIONS: The 2 payment systems are largely comparable regarding patient outcomes, therapy duration, and treatment sessions. Both the average cost per patient per LBP episode and the number of relapses in the product payment system are statistically significantly greater than in the payment-per-session system.

Identifying Patient Characteristics Associated With the Occurrence of Post Treatment Non-serious Adverse Events After Cervical Spine Manual Therapy Treatment in Patients With Neck Pain.

OBJECTIVES: To compare prevalence rates of serious and non-serious adverse events after manipulation and mobilization and to identify risk factors of serious and non-serious adverse events following 4 types of manual therapy treatment in patients with neck pain. DESIGN: A prospective cohort study in primary care manual therapy practice. PARTICIPANTS: Patients with neck pain (N=686) provided data on adverse events after 1014 manipulation treatments, 829 mobilization treatments, 437 combined manipulation and mobilization treatments, and 891 treatments consisting of "other treatment modality". INTERVENTIONS: Usual care manual therapy. MAIN OUTCOME MEASURES: A chi-square test was performed to explore differences in prevalence rates. Logistic regression analysis was performed within the 4 treatment groups. A priori we defined associations between patient-characteristics and adverse events of odds ratio (OR)>2 or OR<0.5 as clinically relevant. RESULTS: No serious adverse events, such as cervical artery dissection or stroke, were reported. With regard to non-serious adverse events, we found that these are common after manual therapy treatment: prevalence rates are ranging from 0.3% to 64.7%. We found a statistically significant difference between the 4 types of treatments, detrimental to mobilization treatment. Logistic regression analysis resulted in 3 main predictors related to non-serious adverse events after manual therapy treatment: smoking (OR ranges from 2.10 [95% confidence interval [CI] 1.37-3.11] to 3.33 [95% CI 1.83-5.93]), the presence of comorbidity (OR ranges from 2.32 [95% CI 1.22-4.44] to 3.88 [95% CI 1.62-9.26]), and female sex (OR ranges from 0.22 [95% CI 0.11-0.46] to 0.49 [95% CI 0.28-0.86]). CONCLUSION: There is a significant difference in the occurrence of non-serious adverse events after mobilization compared with manipulation or a combination of manipulation and mobilization. Non-serious adverse events in manual therapy practice are common and are associated with smoking and the presence of comorbidity. In addition, women are more likely to report non-serious adverse events.

Prevalence and consequences of spinal pain among people with type 1 and type 2 diabetes mellitus in Denmark.

PURPOSE: To describe 1-week and 1-year prevalence of spinal pain and its consequences in relation to leisure activity, work-life, and care-seeking in people with type 1 and 2 diabetes mellitus (DM). METHODS: A cross-sectional survey including adults diagnosed with DM from two Danish secondary care centres. Using the Standardised Nordic Questionnaire, spinal pain prevalence (cervical, thoracic, lumbar) and its consequences were evaluated (proportions, 95% confidence intervals) and compared to the general population. RESULTS: Among 3767 people, 1-week and 1-year spinal pain prevalence were 11.6-32.4 and 18.5-49.6%, respectively, highest for lumbar pain (24.6-49.6%). The prevalence was similar between DM types for cervical and thoracic pain, but higher in type 2 for lumbar spine. Women had higher pain prevalence across spinal regions and DM types, while cervical and thoracic pain estimates were higher for age < 60 vs. ≥ 60. Within the past year, > 50% reported pain > 30 days, high proportions had reduced their activities (leisure time, 43.7-63.9%; work, 20.7-33.3%), 13.3-28.1% reported sick-leave > 30 days, and 44.3-48.5% had sought care due to spinal pain. CONCLUSION: Spinal pain is common in people with type 1 and 2 DM, resulting in considerable consequences for work/leisure activities, sick-leave, and healthcare utilisation as compared to the general population.

Exposure to hand-arm vibrations in the workplace and the occurrence of hand-arm vibration syndrome, Dupuytren's contracture, and hypothenar hammer syndrome: a systematic review and meta-analysis.

This study provides an overview of the relationships between exposure to work-related hand-arm vibration and the occurrence of pre-defined disorders of the hands. We searched Medline, Embase, Web of Science, Cochrane Central, and PsycINFO for cross-sectional and longitudinal studies on the association between work-related vibration exposure and the occurrence of hand-arm vibration syndrome (including vibration-induced white finger), Dupuytren's contracture, or hypothenar hammer syndrome. We used a 16-item checklist for assessing the risk of bias. We present results narratively, and we conducted random effects meta-analyses if possible. We included 10 studies with more than 24,381 participants. Our results showed statistically significant associations between the exposure to hand-arm vibrations and the occurrence of the selected disorders, with pooled odds ratios ranging between 1.35 (95% CI: 1.28 to 2.80) and 3.43 (95% CI: 2.10 to 5.59). Considerable between-study heterogeneity was observed. Our analyses show that exposure to vibrating tools at work is associated with an increased risk for the occurrence of selected disorders of the hands. Due to the majority of studies being cross-sectional, no firm conclusion is possible regarding causal relationships between vibration exposure and disorder occurrence. Future research should specifically address whether reducing exposure to hand-held vibrating tools at work reduces the incidence of the disorders of the hands investigated in this systematic review.

Does Pain Medication Use Influence the Outcome of 8 Weeks of Education and Exercise Therapy in Patients with Knee or Hip Osteoarthritis? An Observational Study.

OBJECTIVE: Patients with osteoarthritis are mainly managed in primary care settings and many patients use pain medication as symptomatic treatment. We investigated in OA-patients receiving an education and exercise program, the use and type of pain medication and its impact on outcomes at 3 months follow-up. DESIGN, SETTING AND SUBJECTS: The design was a retrospective cohort study using prospectively collected data from the GLA: D® registry. The study included 15,918 primary care patients. RESULTS: Among the included patients, 62% were pain medication users and 38% were non-users. Among the pain medications users, 35% were classified as paracetamol users, 54% as NSAID users, and 11% as opioid users. Medication users and non-users differed regarding a higher pain intensity, poorer physical and mental health. Pain medication use before and during the education and exercise program was associated with the pain intensity at 3 months follow-up. However, patients either using or not using pain medications improved over time, and the magnitude of the difference between patient groups was small (less than 10 mm on a 0-100 scale). CONCLUSIONS: Pain medication use is weakly associated with outcome at 3 months follow up in OA-patients receiving an education and exercise program. Between-group differences, however, are small and probably not clinically important.

Effectiveness of non-opioid interventions to reduce opioid withdrawal symptoms in patients with chronic pain: a systematic review.

BACKGROUND: Dealing with the opioid crisis, medical doctors are keen to learn how to best treat opioid dependency in patients with chronic non-cancer pain. Opioid replacement therapy is commonly used, but success rates vary widely. Since many patients still experience severe withdrawal symptoms, additional interventions are necessary. OBJECTIVE: To review the effectiveness of interventions in the treatment of withdrawal symptoms during opioid tapering or acute withdrawal in patients with long-term non-cancer pain. METHODS: A systematic review was conducted in Embase.com, MEDLINE, Web of Science, PsycINFO, and Cochrane CENTRAL register of trials. Studies eligible for inclusion were (non-)randomized controlled trials in adults with long-term opioid prescriptions for non-cancer pain. Included trials had to compare a non-opioid intervention to placebo, usual care, no treatment, or non-opioid drug and had to report on withdrawal symptoms as an outcome. Study quality was assessed with the 2.0 Cochrane risk of bias (RoB) tool. Evidence quality was rated following the GRADE approach. RESULTS: One trial (n = 21, some concerns regarding RoB) compared Varenicline to placebo. There was no statistically significant between-group reduction of withdrawal symptoms (moderate-quality evidence). CONCLUSIONS: Evidence from clinical trials on interventions reducing withdrawal symptoms is scarce. Based on one trial with a small sample size, no firm conclusion can be drawn. Meanwhile, doctors are in dire need for therapeutic options to tackle withdrawal symptoms while tapering patients with prescription opioid dependence. We hope this review draws attention to this unfortunate research gap so that future research can provide doctors with answers.

There is a global increase of patients depended on opioids prescribed by a doctor for chronic non-cancer pain. Tapering these drugs is challenging, especially since treatment options for withdrawal symptoms are lacking. We conducted a systematic review of controlled studies on interventions aimed at reducing withdrawal symptoms during opioid tapering in patients with long term opioid treatment for chronic non-cancer pain. One trial could be included. No firm conclusions can be drawn from this one trial. Hence, this review demonstrates that to improve care for patients depended on opioids for chronic non-cancer pain, more high-quality research in this field is necessary.

Modifiable prognostic factors of high costs related to healthcare utilization among older people seeking primary care due to back pain: an identification and replication study.

BACKGROUND: Back pain is an extensive burden to our healthcare system, yet few studies have explored modifiable prognostic factors associated with high costs related to healthcare utilization, especially among older back pain patients. The aims of this study were to identify modifiable prognostic factors for high costs related to healthcare utilization among older people seeking primary care with a new episode of back pain; and to replicate the identified associations in a similar cohort, in a different country. METHODS: Data from two cohort studies within the BACE consortium were used, including 452 and 675 people aged ≥55 years seeking primary care with a new episode of back pain. High costs were defined as costs in the top 25th percentile. Healthcare utilization was self-reported, aggregated for one-year of follow-up and included: primary care consultations, medications, examinations, hospitalization, rehabilitation stay and operations. Costs were estimated based on unit costs collected from national pricelists. Nine potential modifiable prognostic factors were selected based on previous literature. Univariable and multivariable binary logistic regression models were used to identify and replicate associations (crude and adjusted for selected covariates) between each modifiable prognostic factor and high costs related to healthcare utilization. RESULTS: Four modifiable prognostic factors associated with high costs related to healthcare utilization were identified and replicated: a higher degree of pain severity, disability, depression, and a lower degree of physical health-related quality of life. Kinesiophobia and recovery expectations showed no prognostic value. There were inconsistent results across the two cohorts with regards to comorbidity, radiating pain below the knee and mental health-related quality of life. CONCLUSION: The factors identified in this study may be future targets for intervention with the potential to reduce high costs related to healthcare utilization among older back pain patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04261309, 07 February 2020. Retrospectively registered.

Educational online prevention programme (the SPRINT study) has no effect on the number of running-related injuries in recreational runners: a randomised-controlled trial.

OBJECTIVES: The aim of this study was to examine the effectiveness of an enhanced online injury prevention programme on the number of running-related injuries (RRIs) in recreational runners. METHODS: We conducted a randomised-controlled trial in runners who registered for running events (distances: 10-42.195 km) in the Netherlands. Adult runners who provided informed consent were randomised into the intervention or control group. Participants in the intervention group received access to the online prevention programme, which included items to prevent RRIs. Participants in the control group followed their regular preparation for the running event. The primary outcome measure was the number of new RRIs from baseline to 1 month after the running event. To determine differences between injury proportions, univariate and multivariate logistic regression analyses were performed. RESULTS: This study included 4050 recreational runners (63.5% males; mean (SD) age: 42.3 (12.1) years) for analyses. During follow-up, 35.5% (95% CI: 33.5 to 37.6) of the participants in the intervention group sustained a new RRI compared with 35.4% (95% CI: 33.3 to 37.5) of the participants in the control group, with no between-group difference (OR: 1.03; 95% CI: 0.90 to 1.17). There was a positive association between the number of items followed in the injury prevention programme and the number of RRIs (OR: 1.05; 95% CI: 1.00 to 1.11). CONCLUSION: The enhanced online injury prevention programme had no effect on the number of RRIs in recreational runners, and being compliant with the programme paradoxically was associated with a slightly higher injury rate. Future studies should focus on individual targeted prevention with emphasis on the timing and application of preventive measures. TRIAL REGISTRATION NUMBER: NL7694.

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.

Somatic complaints as a mediator in the association between body mass index and quality of life in children and adolescents.

BACKGROUND: Children and adolescents with overweight are known to have lower Quality of Life (QoL) compared to peers with a normal weight. QoL is a broad concept and is associated with many factors. A better understanding of the factors associated with QoL in children and adolescents and their impact on the association between overweight/obesity and QoL, may help to develop and improve interventions that lead to an improvement in QoL in children/adolescents with a high body mass index (BMI > 25). This study investigated the possible mediating effects of somatic complaints and general practitioner consultations in the association between overweight/obesity and QoL in children and adolescents. METHODS: For the current study, cross-sectional data were used from a longitudinal study, the DOERAK cohort, collected from general practitioners' medical files and through questionnaires. This cohort included 2-18 year olds with normal weight and overweight. Uni- and multivariate regression analyses were performed to gain more insight into variables associated with QoL. Mediation analyses were performed to investigate the possible mediating effects of somatic complaints and GP consultations in the association between overweight/obesity and QoL in children. RESULTS: In the total sample of 733 participants aged 2-18 years, participants with normal weight had a significantly higher QoL (83.64, SD10.65) compared to participants with overweight (78.61, SD14.34) and obesity (76.90, SD13.63) at baseline. The multivariate analyses showed that a lower socio-economic status (SES), higher BMIz, and the presence of somatic complaints are associated with a lower QoL. The mediation analysis showed a significant effect of the indirect pathway of BMIz on QoL through somatic complaints (ß = - 0.46, 95% CI[- 0.90, - 0.06]). CONCLUSION: BMIz has a direct impact on QoL in children and adolescents. Somatic complaints seem to mediate the effect of BMIz on QoL.