Stratified health care for low back pain using the STarT Back approach: Holy Grail or doomed to fail?

ABSTRACT: There have been at least 7 separate randomised controlled trials published between 2011 and 2023 that have examined primary care for nonspecific low back pain informed by the STarT Back approach to stratified care based on risk prediction, compared with care not informed by this approach. The results, across 4 countries, have been contrasting-some demonstrating effectiveness and/or efficiency of this approach, others finding no benefits over comparison interventions. This review considers possible explanations for the differences, particularly whether this is related to poor predictive performance of the STarT Back risk-prediction tool or to variable degrees of success in implementing the whole STarT Back approach (subgrouping and matching treatments to predicted risk of poor outcomes) in different healthcare systems. The review concludes that although there is room for improving and expanding the predictive value of the STarT Back tool, its performance in allocating individuals to their appropriate risk categories cannot alone explain the variation in results of the trials to date. Rather, the learning thus far suggests that challenges in implementing stratified care in clinical practice and in changing professional practice largely explain the contrasting trial results. The review makes recommendations for future research, including greater focus on studying facilitators of implementation of stratified care and developing better treatments for patients with nonspecific low back pain at high risk of poor outcomes.

Musculoskeletal Health and Work: Development and Internal-External Cross-Validation of a Model to Predict Risk of Work Absence and Presenteeism in People Seeking Primary Healthcare.

PURPOSE: To develop and validate prediction models for the risk of future work absence and level of presenteeism, in adults seeking primary healthcare with musculoskeletal disorders (MSD). METHODS: Six studies from the West-Midlands/Northwest regions of England, recruiting adults consulting primary care with MSD were included for model development and internal-external cross-validation (IECV). The primary outcome was any work absence within 6 months of their consultation. Secondary outcomes included 6-month presenteeism and 12-month work absence. Ten candidate predictors were included: age; sex; multisite pain; baseline pain score; pain duration; job type; anxiety/depression; comorbidities; absence in the previous 6 months; and baseline presenteeism. RESULTS: For the 6-month absence model, 2179 participants (215 absences) were available across five studies. Calibration was promising, although varied across studies, with a pooled calibration slope of 0.93 (95% CI: 0.41-1.46) on IECV. On average, the model discriminated well between those with work absence within 6 months, and those without (IECV-pooled C-statistic 0.76, 95% CI: 0.66-0.86). The 6-month presenteeism model, while well calibrated on average, showed some individual-level variation in predictive accuracy, and the 12-month absence model was poorly calibrated due to the small available size for model development. CONCLUSIONS: The developed models predict 6-month work absence and presenteeism with reasonable accuracy, on average, in adults consulting with MSD. The model to predict 12-month absence was poorly calibrated and is not yet ready for use in practice. This information may support shared decision-making and targeting occupational health interventions at those with a higher risk of absence or presenteeism in the 6 months following consultation. Further external validation is needed before the models' use can be recommended or their impact on patients can be fully assessed.

Foot and ankle problems in children and young people: a population-based cohort study.

The aim of this research was to describe the epidemiology, presentation and healthcare use in primary care for foot and ankle problems in children and young people (CYP) across England. We undertook a population-based cohort study using data from the Clinical Practice Research Datalink Aurum database, a database of anonymised electronic health records from general practices across England. Data was accessed for all CYP aged 0-18 years presenting to their general practitioner between January 2015 and December 2021 with a foot and/or ankle problem. Consultation rates were calculated and used to estimate numbers of consultations in an average practice. Hierarchical Poisson regression estimated relative rates of consultations across sociodemographic groups and logistic regression evaluated factors associated with repeat consultations. A total of 416,137 patients had 687,753 foot and ankle events, of which the majority were categorised as "musculoskeletal" (34%) and "unspecified pain" (21%). Rates peaked at 601 consultations per 10,000 patient-years among males aged 10-14 years in 2018. An average practice might observe 132 (95% CI 110 to 155) consultations annually. Odds for repeat consultations were higher among those with pre-existing diagnoses including juvenile arthritis (OR 1.73, 95% CI 1.48 to 2.03).    Conclusions: Consultations for foot and ankle problems were high among CYP, particularly males aged 10 to 14 years. These data can inform service provision to ensure CYP access appropriate health professionals for accurate diagnosis and treatment. What is Known: • Foot and ankle problems can have considerable impact on health-related quality of life in children and young people (CYP). • There is limited data describing the nature and frequency of foot and ankle problems in CYP. What is New: • Foot and ankle consultations were higher in English general practice among CYP aged 10 to 14 years compared to other age groups, and higher among males compared to females. • The high proportion of unspecified diagnoses and repeat consultations suggests there is need for greater integration between general practice and allied health professionals in community-based healthcare settings.

Prognosis of Patients With Neuropathic Low Back-Related Leg Pain: An Exploratory Study Using Prospective Data From UK Primary Care.

This prospective cohort study investigates the prognosis of patients with neuropathic low back-related leg pain consulting in UK primary care. Data from 511 patients were collected using standardised baseline clinical examinations (including magnetic resonance imaging scan findings), self-report questionnaires at baseline, 4 months, 12 months, and 3 years. Cases of possible neuropathic pain (NP) and persistent-NP were identified using either of 2 definitions: 1) clinical diagnosis of sciatica, 2) self-report version of leeds assessment for neurological symptoms and signs (s-LANSS). Mixed-effects models compared pain intensity (highest of mean leg or mean back pain [0-10 Numerical Rating Scale]) over 3-years between persistent-NP versus non-persistent-NP based on 1) clinical diagnosis, 2) s-LANSS. Logistic regression examined associations between potential prognostic factors and persistent-NP at 4 months based on the 2 NP definitions. At 4-months, using both definitions: 1) approximately 4 out of 10 patients had persistent-NP, 2) mean pain intensity was higher for patients with persistent-NP at all follow-up points compared to those without, 3) only pain self-efficacy was significantly associated with persistent-NP (s-LANSS: OR .98, sciatica: .98), but it did not predict cases of persistent-NP in either multivariable model. Based on factors routinely collected from self-report and clinical examination, it was not possible to predict persistent-NP in this population. PERSPECTIVE: This study provides evidence that neuropathic back-related leg pain in patients consulting in primary care is not always persistent. Patients with persistent neuropathic pain had worse outcomes than those without. Neither leg pain intensity, pain self-efficacy nor MRI scan findings predicted cases of persistent neuropathic pain in this patient population.

Development and External Validation of Individualized Prediction Models for Pain Intensity Outcomes in Patients With Neck Pain, Low Back Pain, or Both in Primary Care Settings.

OBJECTIVE: The purpose of this study was to develop and externally validate multivariable prediction models for future pain intensity outcomes to inform targeted interventions for patients with neck or low back pain in primary care settings. METHODS: Model development data were obtained from a group of 679 adults with neck or low back pain who consulted a participating United Kingdom general practice. Predictors included self-report items regarding pain severity and impact from the STarT MSK Tool. Pain intensity at 2 and 6 months was modeled separately for continuous and dichotomized outcomes using linear and logistic regression, respectively. External validation of all models was conducted in a separate group of 586 patients recruited from a similar population with patients' predictor information collected both at point of consultation and 2 to 4 weeks later using self-report questionnaires. Calibration and discrimination of the models were assessed separately using STarT MSK Tool data from both time points to assess differences in predictive performance. RESULTS: Pain intensity and patients reporting their condition would last a long time contributed most to predictions of future pain intensity conditional on other variables. On external validation, models were reasonably well calibrated on average when using tool measurements taken 2 to 4 weeks after consultation (calibration slope = 0.848 [95% CI = 0.767 to 0.928] for 2-month pain intensity score), but performance was poor using point-of-consultation tool data (calibration slope for 2-month pain intensity score of 0.650 [95% CI = 0.549 to 0.750]). CONCLUSION: Model predictive accuracy was good when predictors were measured 2 to 4 weeks after primary care consultation, but poor when measured at the point of consultation. Future research will explore whether additional, nonmodifiable predictors improve point-of-consultation predictive performance. IMPACT: External validation demonstrated that these individualized prediction models were not sufficiently accurate to recommend their use in clinical practice. Further research is required to improve performance through inclusion of additional nonmodifiable risk factors.

Identification and Characterisation of Trajectories of Sickness Absence Due to Musculoskeletal Pain: A 1-Year Population-based Study.

Purpose This study aimed to identify trajectories of sickness absence in workers on sick leave due to musculoskeletal disorders and explore the association between these trajectories and established prognostic factors for sickness absence. Methods We conducted a prospective cohort study of 549 workers (56% women, aged 18-67 years) on sick leave due to musculoskeletal disorders in Norway in 2018-2019. Sickness absence data were collected from the Norwegian sick leave registry and prognostic factors via self-reported baseline questionnaires. We used group-based trajectory modelling to define the different trajectories of sickness absence spanning a 1-year period. Multivariable multinomial logistic regression was used to estimate odds ratios and 95% confidence intervals for prognostic factors associated with the identified trajectory groups. Results We identified six distinct trajectories of sickness absence over 1 year: 'fast decrease' (27% of the cohort): 'moderate decrease' (22%); 'slow decrease' (12%); 'u-shape' (7%); 'persistent moderate' (13%); and 'persistent high' (18%). Prognostic factors, such as previous sickness absence days, return-to-work expectancy, workability, multisite pain, and health scores, differentiated between the sickness absence trajectories (all P < 0.05). Negative return-to-work expectancy was associated with the three trajectory groups with the highest number of sickness absence days ('slow decrease', 'persistent moderate', and 'persistent high'). Conclusions This is the first study to explore the association of return-to-work expectancy with trajectories of sickness absence. Our findings highlight different patterns of sickness absence and the complex range of prognostic factors. These findings have implications for secondary and tertiary prevention strategies for work absence in workers with musculoskeletal disorders.

Comparison of health-care utilization, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool.

OBJECTIVES: The aim of this study was to describe and compare health economic outcomes [health-care utilization and costs, work outcomes, and health-related quality of life (EQ-5D-5L)] in patients classified into different levels-of-risk subgroups by the Keele STarT MSK Tool. METHODS: Data on health-care utilization, costs and EQ-5D-5L were collected from a health-care perspective within a primary care prospective observational cohort study. Patients presenting with one (or more) of the five most common musculoskeletal pain presentations were included: back, neck, shoulder, knee or multi-site pain. Participants at low, medium and high risk of persistent disabling pain were compared in relation to mean health-care utilization and costs, health-related quality of life, and employment status. Regression analysis was used to estimate costs. RESULTS: Over 6 months, the mean (s.d.) total health-care (National Health Service and private) costs associated with the low, medium, and high-risk subgroups were £132.92 (167.88), £279.32 (462.98) and £476.07 (716.44), respectively. Mean health-related quality of life over the 6-month period was lower and more people changed their employment status in the high-risk subgroup compared with the medium- and low-risk subgroups. CONCLUSIONS: This study demonstrates that subgroups of people with different levels of risk for poor musculoskeletal pain outcomes also have different levels of health-care utilization, health-care costs, health-related quality of life, and work outcomes. The findings show that the STarT MSK Tool not only identifies those at risk of a poorer outcome, but also those who will have more health-care visits and incur higher costs.

Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial.

Background: Risk-based stratified care shows clinical effectiveness and cost-effectiveness versus usual primary care for non-specific low back pain but is untested for other common musculoskeletal disorders. We aimed to test the clinical effectiveness and cost-effectiveness of point-of-care risk stratification (using Keele's STarT MSK Tool and risk-matched treatments) versus usual care for the five most common musculoskeletal presentations (back, neck, knee, shoulder, and multi-site pain). Methods: In this cluster-randomised, controlled trial in UK primary care with embedded qualitative and health economic studies we recruited patients from 24 general practices in the West Midlands region of England. Eligible patients were those aged 18 years or older whose general practitioner (GP) confirmed a consultation for a musculoskeletal presentation. General practices that consented to participate via a representative of the cluster were randomly assigned (1:1) to intervention or usual care, using stratified block randomisation. Researchers involved in data collection, outcome data entry, and statistical analysis were masked at both the cluster and individual participant level. Participating patients were told the study was examining GP treatment of common aches and pains and were not aware they were in a randomised trial. GPs in practices allocated to the intervention group were supported to deliver risk-based stratified care using a bespoke computer-based template, including the risk-stratification tool, and risk-matched treatment options for patients at low, medium, or high risk of poor disability or pain outcomes. There were 15 risk-matched treatment options. In the usual care group, patients with musculoskeletal pain consulting their GP received treatment as usual, typically including advice and education, medication, referral for investigations or tests, or referral to other services. The primary outcome was time-averaged pain intensity over 6 months. All analyses were done by intention to treat. The trial is registered with ISRCTN, ISRCTN15366334. Results: Between May 1, 2018, and April 30, 2019, 104 GPs from 24 practices (12 per study group) identified 2494 patients with musculoskeletal pain. 1211 (49%) participants consented to questionnaires (534 in the intervention group and 677 in the usual care group), with 1070 (88%) completing the follow-up questionnaire at 6 months. We found no significant difference in time-averaged pain intensity (mean(SD) mean 4·4 [SD 2·3] in the intervention group vs 4·6 [2·5] in the control group; adjusted mean difference -0·16, 95% CI -0·65 to 0·34) or in standardised function score (mean -0·06 [SD 0·94] in the intervention group vs 0·05 [1·04]; adjusted mean difference -0·07, 95% CI -0·22 to 0·08). No serious adverse events or adverse events were reported. Risk stratification received positive patient and clinician feedback. Interpretation: Risk stratification for patients in primary care with common musculoskeletal presentations did not lead to significant improvements in pain or function, although some aspects of GP decision making were affected, and GP and patients had positive experiences. The costs of risk-based stratified care were similar to usual care, and such a strategy only offers marginal changes in cost-effectiveness outcomes. The clinical implications from this trial are largely inconclusive. Funding: National Institute for Health Research.

Stratifying workers on sick leave due to musculoskeletal pain: translation, cross-cultural adaptation and construct validity of the Norwegian Keele STarT MSK tool.

OBJECTIVES: Stratified care using prognostic models to estimate the risk profiles of patients has been increasing. A refined version of the popular STarT Back tool, the Keele STarT MSK tool, is a newly developed model for matched treatment across a wide range of musculoskeletal pain presentations. The aim of this study was to translate and culturally adapt the Keele STarT MSK tool into Norwegian, examine its construct validity and assess the representativeness of the included sample. METHODS: The Keele STarT MSK tool was formally translated into Norwegian following a multistep approach of forward and backward translation. A pre-final version was tested in 42 patients. Minor changes were implemented. To assess its construct validity, an online survey was conducted among workers aged 18-67 years who were on sick leave (>4 weeks) due to musculoskeletal disorders. Construct validity was evaluated in terms of convergent and discriminant validity using Pearson's correlation coefficient, and known-group validity by comparing risk subgroups as suggested by the COSMIN checklist. The representativeness of the sample was assessed by comparing demographic and sick leave information of participants to eligible non-participants (n=168,137). RESULTS: A representative sample of 549 workers participated in the validity assessment; 74 participants (13.5%) were categorised as low risk, 314 (57.2%) as medium risk and 161 (29.3%) as high risk. The construct validity was found sufficient, with 90.9% and 75.0% of the pre-defined hypotheses confirmed for convergent and discriminant validity, and known-group validity, respectively. Floor or ceiling effects were not found. CONCLUSIONS: The Keele STarT MSK tool was successfully translated into Norwegian. The construct validity of the tool was acceptable in a representative cohort of workers on sick leave as a result of musculoskeletal pain. However, the analyses raised concerns as to whether one of the questions captures the construct it is intended to measure.

Chronic widespread pain in children and adolescents presenting in primary care: prevalence and associated risk factors.

ABSTRACT: A significant proportion of children/adolescents report chronic widespread pain (CWP), but little is known about clinically relevant CWP or what factors lead to onset in this population. Objectives were to report the primary care consultation prevalence of CWP and investigate risk factors associated with onset. A validated algorithm for identifying CWP status from primary care electronic healthcare records was applied to a child or adolescent population (aged 8-18 years). The algorithm records patients who have recurrent pain consultations (axial skeleton and upper or lower limbs) or those with a nonspecific generalised pain disorder (eg, fibromyalgia). Prevalence was described, and a nested case-control study was established to identify risk factors associated with CWP onset using logistic regression producing odds ratios (ORs) and 95% confidence intervals (95% CIs). Two hundred seventy-one children or adolescents were identified with CWP, resulting in a 5-year consultation prevalence of 3.19%. Risk factors significantly associated with CWP onset were as follows: mental health (eg, anxiety/neurosis consultations), neurological (eg, headaches), genitourinary (eg, cystitis), gastrointestinal (eg, abdominal pain), and throat problems (eg, sore throats). Children or adolescents with 1 or 2 risk factors (OR 2.15, 95% CI 1.6-2.9) or 3 or more risk factors (OR 9.17, 95% CI 5.9-14.3) were at significantly increased odds of CWP onset compared with those with none. Findings show a significant proportion of the child or adolescent primary care population has CWP. Most risk factors involved pain-related conditions, suggesting potential pathways of pain development. Further work is now needed to better understand the development of CWP in children and adolescents.

Refinement and validation of a tool for stratifying patients with musculoskeletal pain.

BACKGROUND: Patients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost-effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients. METHODS: Tool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF-36 Physical Component Score [PCS]) and pain intensity were assessed at 2- and 6-month cohort follow-up; pain intensity was measured at 6-month trial follow-up. RESULTS: The tool was refined by replacing (3), adding (3) and removing (2) items, resulting in a 10-item tool. Model fit (R2 ) was 0.422 and 0.430 and discrimination (c statistic) 0.839 and 0.822 for predicting 6-month cohort PCS and pain (respectively). The tool classified 24.9% of cohort participants at low, 41.7% medium and 33.4% high risk, clearly discriminating between subgroups. The tool demonstrated model fit of 0.224 and discrimination 0.73 in trial participants. Multiple imputation confirmed robustness of findings. CONCLUSIONS: The Keele STarT MSK Tool demonstrates good validity and acceptable predictive performance and clearly identifies groups of musculoskeletal pain patients with different characteristics and prognosis. Using prognostic information for stratification and treatment matching may be clinically/cost-effective. SIGNIFICANCE: The paper presents the first musculoskeletal pain prognostic stratification tool specifically for use among all primary care patients with the five most common musculoskeletal pain presentations (back, neck, knee, shoulder or multisite pain). The Keele STarT MSK Tool identifies groups of musculoskeletal pain patients with clearly different characteristics and prognosis. Using this tool for stratification and treatment matching may be clinically and cost-effective.

Are psychological symptoms a risk factor for musculoskeletal pain in adolescents?

Adolescent musculoskeletal pain is common and is associated with musculoskeletal pain in adulthood. Psychological symptoms, also common in adolescence, have been shown to be associated with musculoskeletal pain, but the current evidence is mixed and may be dependent on effect modifiers. This study investigated whether adolescents with psychological symptoms (internalizing and externalizing constructs) at age 13 years were at higher odds for musculoskeletal pain at age 17 years and whether the associations were modified by pubertal status and sex. A prospective cohort design examined data on 3865 adolescents from the Avon Longitudinal Study of Parents and Children (ALSPAC). Associations between baseline (aged 13 years) internalizing and externalizing symptoms and musculoskeletal pain at follow-up (aged 17 years) were investigated using logistic regression producing odds ratios (OR) and 95% confidence intervals (95% CI). In total 43.1% of adolescents reported musculoskeletal pain at follow-up. Externalizing symptoms at baseline increased the odds of musculoskeletal pain (OR 1.68, 95% CI 1.28, 2.20), and internalizing symptoms demonstrated a non-significant increase (OR 1.26, 95% CI 0.98, 1.62). Effect modification analysis showed an increased effect dependent on pubertal status.Conclusion: Adolescents with externalizing symptoms, and to some extent internalizing symptoms, are at increased odds of later musculoskeletal pain. Future research is now required to understand the reasons for these associations. What is Known: • Current evidence regarding the association between internalizing symptoms and externalizing symptoms and future musculoskeletal pain in adolescents is mixed. What is New: • This study found that adolescents with externalizing symptoms, and to some extent internalizing symptoms, are at increased odds for musculoskeletal pain, with an increased influence dependent on pubertal status. • These results are of interest for the development of timely preventative interventions designed to reduce the risk of musculoskeletal pain.

Family-based Interventions Benefit Individuals With Musculoskeletal Pain in the Short-term but not in the Long-Term: A Systematic Review and Meta-Analysis.

INTRODUCTION: The benefits of family-based interventions for patients with musculoskeletal pain have been previously shown in individual randomized controlled trials (RCTs), but no systematic review has summarized their effects. MATERIALS AND METHODS: A systematic review was conducted to assess the effectiveness of family-based interventions on clinical and biopsychosocial outcomes in people with musculoskeletal pain (PROSPERO CRD42018118442). Meta-analyses were performed for the outcomes of pain intensity, disability, mood, self-efficacy, and marital adjustment. RESULTS: Of 1223 records identified, 18 reports representing 15 RCTs were included in the qualitative review and 10 in the meta-analyses. Family-based interventions were more effective to reduce pain (mean difference [MD], -3.55/100; 95% confidence intreval [CI], -4.03 to -3.06) and disability (MD, -1.51/100; 95% CI, -1.98 to -1.05) than individual-focused interventions at short-term, but not at mid term or long term. There were no effects on other outcomes. Family-based interventions were more effective to reduce pain (MD, -6.05/100; 95% CI, -6.78 to -5.33) compared with usual care only at short-term. No effects were found on disability and other outcomes. DISCUSSION: There is moderate-quality evidence that family-based interventions result in small, significantly better pain and disability outcomes in the short-term compared with individual-focused interventions in patients with musculoskeletal pain. Based on low-quality evidence, family-based interventions result in small improvements on pain in the short-term compared with usual care. Future studies should review the content and optimize the mechanisms underpinning family-based interventions in musculoskeletal pain so that the approach could be further tested in adequately powered RCTs.

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.

BACKGROUND: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. OBJECTIVES: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. DESIGN: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. SETTING: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. PARTICIPANTS: Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. INTERVENTIONS: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. MAIN OUTCOME MEASURES: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist. RESULTS: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. CONCLUSIONS: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. LIMITATIONS: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. FUTURE WORK: Other approaches to stratified care may provide superior outcomes for sciatica. TRIAL REGISTRATION: Current Controlled Trials ISRCTN75449581. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.

Sciatica is pain that spreads into the leg because of a trapped nerve in the lower back. It can be a very painful condition that affects everyday life and ability to work. People with sciatica usually see their general practitioner first; if they do not get better over time, they may be referred to a physiotherapist or, eventually, to a spinal specialist. It is difficult to know which sciatica patient will do well without much treatment and who might need to see a physiotherapist or spinal specialist sooner. Stratified care is an approach aiming to help decide, early on, which patients need to see which health professionals. It has previously been shown to be helpful for patients with lower-back pain. In a trial of 476 patients with sciatica a stratified care model was tested to see if it led to faster improvements in sciatica-related leg pain, when compared with usual care. Adults seeing their general practitioner with sciatica were invited to attend a research clinic. Those willing to take part were randomly assigned to stratified care or usual care. Patients in the stratified care arm were referred either to physiotherapy for a short or a longer course of treatment, or to undergo magnetic resonance imaging and see a spinal specialist with the magnetic resonance imaging results within 4 weeks. Pain, function and quality-of-life data were collected over 12 months using text messages and questionnaires. Although patients in the stratified care arm improved slightly more quickly (2 weeks, on average), we did not find convincing evidence that stratified care led to better results than usual care. On average, most patients in both trial arms improved in a similar way over 12 months. The stratified care model tested in this trial did not lead to faster recovery for patients with sciatica than usual care.

Prevalence, Characteristics, and Clinical Course of Neuropathic Pain in Primary Care Patients Consulting With Low Back-related Leg Pain.

OBJECTIVES: Little is known about the epidemiology of neuropathic pain in primary care patients consulting with low back-related leg pain. We aimed to describe prevalence, characteristics, and clinical course of low back-related leg pain patients with and without neuropathic pain, consulting with their family doctor in the United Kingdom. MATERIALS AND METHODS: This was a prospective cohort study. Data were collected using a standardized baseline clinical examination and self-report questionnaires at baseline, 4, 12, and 36 months. We identified cases of neuropathic pain using 3 definitions: 2 based on clinical diagnosis (sciatica, with and without evidence of nerve root compression on magnetic resonance imaging), one on the self-report version of Leeds Assessment for Neurological Symptoms and Signs. Differences between patients with and without neuropathic pain were analyzed comparing each definition. Clinical course (mean pain intensity measured as the highest of leg or back pain intensity: mean of 3 Numerical Rating Scales, each 0 to 10) was investigated using linear mixed models over 36 months. RESULTS: Prevalence of neuropathic pain varied from 48% to 74% according to definition used. At baseline, patients with neuropathic pain had more severe leg pain intensity, lower pain self-efficacy, more patients had sensory loss than those without. Distinct profiles were apparent depending on neuropathic pain definition. Mean pain intensity reduced after 4 months (6.1 to 3.9 [sciatica]), most rapidly in cases defined by clinical diagnosis. DISCUSSION: This research provides new information on the clinical course of neuropathic pain and a better understanding of neuropathic pain in low back-related leg pain patients consulting in primary care.

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

BACKGROUND: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. METHODS: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. FINDINGS: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care. INTERPRETATION: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. FUNDING: National Institute for Health Research.

Risk factors for non-specific neck pain in young adults. A systematic review.

BACKGROUND: Young adulthood is a sensitive period of life where development of musculoskeletal neck pain may be established and impact future health. The objective of this systematic review was to investigate risk factors for non-specific neck pain in young adults. METHODS: Systematic searches were conducted in six databases in September 2019. Prospective cohorts and registry studies including participants in whom the risk factor or the outcome (neck pain) was registered in the ages 18-29 years old were included. The Quality in Prognosis Studies tool was used for quality assessment. A modification of the Grading of Recommendations Assessments, Development and Evaluation was used to assess the overall quality of the evidence. Potential risk factors investigated in more than one study were summarised. RESULTS: Searches yielded 4527 articles, of which six matched the eligibility criteria. Fifty-six potential risk factors were investigated in the six studies, covering a broad range of domains. Five risk factors were investigated in more than one study (female sex, body mass index (BMI), physical activity, duration of computer use and perceived stress). Physical activity and BMI showed no association with neck pain, and inconsistent results were found for female sex, duration of daily computer use and perceived stress. Risk of bias was moderate or high in all studies, and the overall quality of evidence was very low. CONCLUSION: The studies included many potential risk factors, but none of them showed consistent associations with neck pain. There is a paucity of high-quality studies investigating risk factors for neck pain in young adults.

Sleep problems increase the risk of musculoskeletal pain in boys but not girls: a prospective cohort study.

Adults with sleep problems are at higher risk for onset of musculoskeletal pain, but the evidence is less clear for children. This prospective cohort study investigated whether children with sleep problems are at higher risk for onset of musculoskeletal pain and explored whether sex is a modifier of this association. In a prospective cohort study of Australian schoolchildren (n = 1239, mean age 9 years), the associations between sleep problems at baseline and new onset of both musculoskeletal pain and persistent musculoskeletal pain (pain lasting > 3 months) 1 year later were investigated using logistic regression. The potential modifying effect of sex was also assessed. One-year incidence proportion for musculoskeletal pain onset is 43% and 7% for persistent musculoskeletal pain. Sleep problems were associated with musculoskeletal pain onset and persistent musculoskeletal pain onset in boys, odds ratio 2.80 (95% CI 1.39, 5.62) and OR 3.70 (1.30, 10.54), respectively, but not girls OR 0.58 (0.28, 1.19) and OR 1.43 (0.41, 4.95), respectively.Conclusions: Rates of musculoskeletal pain are high in children. Boys with sleep problems are at greater risk of onset of musculoskeletal pain, but girls do not appear to have higher risk. Consideration of sleep health may help prevent persistent musculoskeletal pain in children. What is Known: • Sleep problems are associated with the onset of musculoskeletal pain in adults. • It is not clear if the association between sleep problems and the onset of musculoskeletal pain is present also in children and if sex plays a role in this association. What is New: • This is the first large population-based study that has prospectively investigated the relationship between sleep problems and onset of musculoskeletal pain in school-aged children. • Children, especially boys with sleep problems, were at increased risk for the development of persistent musculoskeletal pain.

Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.

BACKGROUND: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations. OBJECTIVE: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care. METHODS: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons. RESULTS: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020. CONCLUSIONS: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17939.