Development of low back pain curriculum content standards for entry-level clinical training.

BACKGROUND: The management of low back pain (LBP) is highly variable and patients often receive management that is not recommended and/or miss out on recommended care. Clinician knowledge and behaviours are strongly influenced by entry-level clinical training and are commonly cited as barriers to implementing evidence-based management. Currently there are no internationally recognised curriculum standards for the teaching of LBP content to ensure graduating clinicians have the appropriate knowledge and competencies to assess and manage LBP. We formed an international interdisciplinary working group to develop curriculum content standards for the teaching of LBP in entry-level clinical training programs. METHODS: The working group included representatives from 11 countries: 18 academics and clinicians from healthcare professions who deal with the management of LBP (medicine, physiotherapy, chiropractic, osteopathy, pharmacology, and psychology), seven professional organisation representatives (medicine, physiotherapy, chiropractic, spine societies), and one healthcare consumer. A literature review was performed, including database and hand searches of guidelines and accreditation, curricula, and other policy documents, to identify gaps in current LBP teaching and recommended entry-level knowledge and competencies. The steering group (authors) drafted the initial LBP Curriculum Content Standards (LBP-CCS), which were discussed and modified through two review rounds with the working group. RESULTS: Sixty-two documents informed the draft standards. The final LBP-CCS consisted of four broad topics covering the epidemiology, biopsychosocial contributors, assessment, and management of LBP. For each topic, key knowledge and competencies to be achieved by the end of entry-level clinical training were described. CONCLUSION: We have developed the LBP-CCS in consultation with an interdisciplinary, international working group. These standards can be used to inform or benchmark the content of curricula related to LBP in new or existing entry-level clinical training programs.

Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial.

BACKGROUND: Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain. METHODS: RESTORE was a randomised, controlled, three-arm, parallel group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study's questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001396213. FINDINGS: Between Oct 23, 2018 and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference -4·6 [95% CI -5·9 to -3·4] and CFT plus biofeedback mean difference -4·6 [-5·8 to -3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; -AU$5276 [-10 529 to -24) and -8211 (-12 923 to -3500). INTERPRETATION: CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care. FUNDING: Australian National Health and Medical Research Council and Curtin University.

Patients with low back pain presenting for chiropractic care who want diagnostic imaging are more likely to receive referral for imaging: a cross-sectional study.

BACKGROUND: It is unclear if the use of imaging for low back pain (LBP) is impacted by patient beliefs. This study aimed to: (1) describe beliefs about the importance of imaging and whether patients wanted imaging when presenting for chiropractic care for LBP; (2) describe associations between baseline patient characteristics and imaging beliefs and whether patients wanted imaging; and (3) determine whether patients who believed imaging to be important in the management of LBP, or who wanted to receive imaging, were more likely to receive an imaging referral. METHODS: Cross-sectional observational data was collected between November 2016 to December 2019 from 10 primary care chiropractic clinics in Denmark. Consecutive patients aged 18 or older and presenting with a new episode of LBP were included (N = 2818). Beliefs about the importance of imaging (two questions) and whether imaging was wanted (one question) were collected at the initial visit, together with baseline participant characteristics and whether an imaging referral was provided. Associations between imaging beliefs/desire to receive imaging and participant characteristics were explored using multivariable logistic regression analysis. The relationships between imaging beliefs and desire to receive imaging with subsequent imaging referral were assessed using multivariable logistic regression analysis adjusted for pre-selected confounder variables. RESULTS: Approximately one third of participants believed imaging to be important for the management of LBP (29.5% (95%CI 27.8, 31.3) or 41.5% (95%CI 39.6, 43.3) depending on the two imaging beliefs questions). Approximately one quarter (26.1%, 95%CI 24.5, 27.7) of participants wanted to receive an imaging referral. Participants were more likely to believe in the importance of imaging or want an imaging referral if they had a longer duration of LBP, history of previous imaging for LBP, or a lower completed education level. Participants who wanted imaging at the initial consult were more likely to receive an imaging referral (Odds ratio; 95%CI 1.6; 1.2, 2.1). CONCLUSIONS: Approximately one third of patients presenting for chiropractic care in Denmark believed imaging to be important in the management of LBP. One quarter wanted imaging at the initial consult. Patients' desire for imaging appeared to impact the use of diagnostic imaging.

What are the effects of diagnostic imaging on clinical outcomes in patients with low back pain presenting for chiropractic care: a matched observational study.

BACKGROUND: Evidence suggests that diagnostic imaging for low back pain does not improve care in the absence of suspicion of serious pathology. However, the effect of imaging use on clinical outcomes has not been investigated in patients presenting to chiropractors. The aim of this study was to determine if diagnostic imaging affects clinical outcomes in patients with low back pain presenting for chiropractic care. METHODS: A matched observational study using prospective longitudinal observational data with one year follow up was performed in primary care chiropractic clinics in Denmark. Data was collected from November 2016 to December 2019. Participants included low back pain patients presenting for chiropractic care, who were either referred or not referred for diagnostic imaging during their initial visit. Patients were excluded if they were less than 18 years old, had a diagnosis of underlying pathology, or had previous imaging relevant to their current clinical presentation. Coarsened exact matching was used to match participants referred for diagnostic imaging with participants not referred for diagnostic imaging on baseline variables including participant demographics, pain characteristics, and clinical history. Mixed linear and logistic regression models were used to assess the effect of imaging on back pain intensity and disability at two-weeks, three-months, and one-year, and on global perceived effect and satisfaction with care at two-weeks. RESULTS: 2162 patients were included, with 24.1% referred for imaging. Near perfect balance between matched groups was achieved for baseline variables except age and leg pain. Participants referred for imaging had slightly higher back pain intensity at two-weeks (0.4, 95%CI: 0.1, 0.8) and one-year (0.4, 95%CI: 0.0, 0.7), and disability at two-weeks (5.7, 95%CI: 1.4, 10.0), but the changes are unlikely to be clinically meaningful. No difference between groups was found for the other outcome measures. Similar results were found when sensitivity analysis, adjusted for age and leg pain intensity, was performed. CONCLUSIONS: Diagnostic imaging did not result in better clinical outcomes in patients with low back pain presenting for chiropractic care. These results support that current guideline recommendations against routine imaging apply equally to chiropractic practice.

Consent to discuss participation in research: a pilot study.

BACKGROUND: Equitable access to research studies needs to be increased for all patients. There is debate about which is the best approach to use to discuss participation in research in real-world clinical settings. OBJECTIVE: We aimed to determine the feasibility of asking all clinical staff within one hospital Trust (an organisation that provides secondary health services within the English and Welsh National Health Service) to use a newly created form on the Trust's electronic patient records system, as a means of asking patients to consent to discuss participation in research (the opt-in approach). We also aimed to collect feedback from patients and clinicians about their views of the opt-in approach. METHODS: Four pilot sites were selected in the Trust: two memory clinics, an adult mental health team and an acute adult ward. Data were collected in three phases: (1) for 6 months, pilot site staff were asked to complete a consent to discuss participation in research form with patients; (2) staff feedback on the form was collected through an online survey; and (3) patient feedback was collected through focus groups. FINDINGS: Of 1779 patients attending services during the pilot period, 197 (11%) had a form completed by staff and 143 (8%) opted-in to finding out about research. Staff cited limited time, low priority and poor user experience of the electronic patient records system as reasons for low uptake of the form. Patients generally approved of the approach but offered suggestions for improvement. CONCLUSIONS: There were mixed results for adopting an opt-in approach; uptake was very low, limiting its value as an effective strategy for improving access to research. CLINICAL IMPLICATIONS: Alternative strategies to the opt-in approach, such as transparent opt out approaches, warrant consideration to maximise access to research within routine clinical care.

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP. METHODS AND ANALYSIS: Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L . ETHICS AND DISSEMINATION: Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Staphylococcal Superantigens Use LAMA2 as a Coreceptor To Activate T Cells.

Canonical Ag-dependent TCR signaling relies on activation of the src-family tyrosine kinase LCK. However, staphylococcal superantigens can trigger TCR signaling by activating an alternative pathway that is independent of LCK and utilizes a Gα11-containing G protein-coupled receptor (GPCR) leading to PLCß activation. The molecules linking the superantigen to GPCR signaling are unknown. Using the ligand-receptor capture technology LRC-TriCEPS, we identified LAMA2, the α2 subunit of the extracellular matrix protein laminin, as the coreceptor for staphylococcal superantigens. Complementary binding assays (ELISA, pull-downs, and surface plasmon resonance) provided direct evidence of the interaction between staphylococcal enterotoxin E and LAMA2. Through its G4 domain, LAMA2 mediated the LCK-independent T cell activation by these toxins. Such a coreceptor role of LAMA2 involved a GPCR of the calcium-sensing receptor type because the selective antagonist NPS 2143 inhibited superantigen-induced T cell activation in vitro and delayed the effects of toxic shock syndrome in vivo. Collectively, our data identify LAMA2 as a target of antagonists of staphylococcal superantigens to treat toxic shock syndrome.

Influence of clinician characteristics and operational factors on recruitment of participants with low back pain: an observational study.

OBJECTIVE: The purpose of this study was to identify factors that influence recruitment of patients to an observational study of low back pain (LBP). METHODS: From 1147 primary care (first health contact) clinicians initially contacted, 138 (physiotherapists and chiropractors) agreed to participate in a large observational study of LBP and were the focus of the current study. Data were collected pertaining to clinicians' characteristics, operational factors, and the number of patients recruited. The association of a variety of clinician characteristics and operational factors with recruitment rate was determined using a multivariate negative binomial regression analysis. RESULTS: From October 2011 to November 2012, 1585 patients were screened by 138 study clinicians with 951 eligible patients entering the observational study. Clinicians who were members of their professional association had a recruitment rate less than half that of those who were nonmembers (P < .0001). Clinicians who were trained by telephone had a recruitment rate 4.01 times higher than those trained face to face (P < .0001). Similarly, clinicians who referred a larger number of ineligible participants had a slightly higher recruitment rate with an incident rate ratio of 1.04 per ineligible patient (P < .0001). Other clinicians' characteristics and operational factors were not associated with recruitment. CONCLUSION: This study provides evidence that it is feasible to recruit participants from primary care practices to a simple observational study of LBP. Factors identified as influencing recruitment were professional association (negative association), training by telephone, and referring a higher number of ineligible participants.

A guide to survival analysis for manual therapy clinicians and researchers.

Survival analysis is a statistical approach used to study time to an event of interest. The approach is highly applicable to the manual therapy discipline, yet is rarely used. This masterclass aims to present a simple overview of survival analysis aimed at both clinicians and researchers in the manual therapy field. Specifically the masterclass aims to 1) describe situations where survival analysis is appropriate to use 2) describe unique characteristics of survival data including censoring of participants 3) describe analysis methods for survival data including log rank test and Cox regression 4) describe the interpretation of results from survival analyses including survival plots and hazard ratios.

Approach to low back pain - physiotherapy.

This article forms part of our allied health series for 2014, which aims to provide information about the management approach of different allied health professionals, using the case example of uncomplicated, mechanical low back pain.

Does the addition of visceral manipulation improve outcomes for patients with low back pain? Rationale and study protocol.

OBJECTIVES: There has been no randomised controlled trial conducted to investigate the effectiveness of visceral manipulation (VM) for the treatment of low back pain (LBP). The primary aim of this study would be to investigate whether the addition of VM, to a standard physiotherapy treatment regimen, improves pain 6 weeks post treatment commencement in people with LBP. Secondary aims would be to examine the effect of VM on disability and functional outcomes at 2, 6 and 52 weeks post-treatment commencement and pain at 2 and 52 weeks. METHODS: This paper describes the rationale and design of a randomised controlled trial investigating the addition of VM to a standard physiotherapy treatment algorithm which includes manual therapy, specific exercise and functional exercise prescription. Analysis of data would be carried out by a statistician blinded to group allocation and by intention-to-treat.