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.

Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model?

The overall quality of care for musculoskeletal pain conditions is suboptimal, partly due to a considerable evidence-practice gap. In osteoarthritis and low back pain, structured models of care exist to help overcome that challenge. In osteoarthritis, focus is on stepped care models, where treatment decisions are guided by response to treatment, and increasingly comprehensive interventions are only offered to people with inadequate response to more simple care. In low back pain, the most widely known approach is based on risk stratification, where patients with higher predicted risk of poor outcome are offered more comprehensive care. For both conditions, the recommended interventions and models of care share many commonalities and there is no evidence that one model of care is more effective than the other. Limitations of existing models of care include a lack of integrated information on social factors, comorbid conditions, and previous treatment experience, and they do not support an interplay between health care, self-management, and community-based activities. Moving forwards, a common model across musculoskeletal conditions seems realistic, which points to an opportunity for reducing the complexity of implementation. We foresee this development will use big data sources and machine-learning methods to combine stepped and risk-stratified care and to integrate self-management support and patient-centred care to a greater extent in future models of 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).

In a secondary care setting, differences between neck pain subgroups classified using the Quebec task force classification system were typically small - a longitudinal study.

BACKGROUND: The component of the Quebec Task Force Classification System that subgroups patients based on the extent of their radiating pain and neurological signs has been demonstrated to have prognostic implications for patients with low back pain but has not been tested on patients with neck pain (NP). The main aim of this study was to examine the association between these subgroups, their baseline characteristics and outcome in chronic NP patients referred to an outpatient hospital department. METHODS: This was an observational study of longitudinal data extracted from systematically collected, routine clinical data. Patients were classified into Local NP only, NP + arm pain above the elbow, NP + arm pain below the elbow, and NP with signs of nerve root involvement (NP + NRI). Outcome was pain intensity and activity limitation. Associations were tested in longitudinal linear mixed models. RESULTS: A total of 1,852 people were classified into subgroups (64 % females, mean age 49 years). Follow ups after 3, 6 and 12 months were available for 45 %, 32 % and 40 % of those invited to participate at each time point. A small improvement in pain was observed over time in all subgroups. There was a significant interaction between subgroups and time, but effect sizes were small. The local NP subgroup improved slightly less after 3 months as compared with all other groups, but continued to have the lowest level of pain. After 6 and 12 months, those with NP + pain above the elbow had improved the least and patients with NP + NRI had experienced the largest improvements in pain intensity. Similar results were obtained for activity limitation. CONCLUSIONS: This study found baseline and outcome differences between neck pain subgroups classified using the Quebec Task Force Classification System. However, differences in outcome were typically small in size and mostly differentiated the local NP subgroup from the other subgroups. A caveat to these results is that they were obtained in a cohort of chronic neck pain patients who only displayed small improvements over time and the results may not apply to other cohorts, such as people at earlier stages of their clinical course and in other clinical settings.

The predictive ability of the STarT Back Screening Tool in a Danish secondary care setting.

INTRODUCTION: The predictive ability of the STarT Back Tool (SBT) in secondary care settings has not been investigated. The aim of this study was to determine the SBT's predictive ability in a Danish secondary care setting and compare this to a Danish primary care setting. METHODS: Poor clinical outcome at 6 months (>30 points on a 0-100 Roland Morris Disability Scale) was calculated in secondary care (n = 960) and primary care (n = 172) cohorts. The cohorts were stratified into SBT subgroups and estimates of additional risk for poor outcome were calculated [relative risk (RR), unadjusted and adjusted odds ratios]. The discriminative ability was determined using the area under the curve statistic. RESULTS: In secondary care 69.0 % and in primary care 40.2 % had poor outcome on activity limitation. Although significant, the predictive ability of the SBT in secondary care (medium-risk RR 1.5, high-risk RR 1.7) was not as strong as in primary care (medium-risk RR 2.3, high-risk RR 3.5). Adjusting for episode duration and pain intensity only changed the predictive ability marginally in secondary care. The discriminative ability of the SBT was similar in both cohorts despite differences in the predictive ability. CONCLUSION: The SBT had less predictive ability in a Danish secondary care setting compared to a Danish primary care setting for persistent activity limitation at 6 months follow-up. SBT-targeted treatment implications in secondary care were not investigated in this study.

Patients with low back pain differ from those who also have leg pain or signs of nerve root involvement - a cross-sectional study.

BACKGROUND: Leg pain associated with low back pain (LBP) is recognized as a risk factor for a poor prognosis, and is included as a component in most LBP classification systems. The location of leg pain relative to the knee and the presence of a positive straight leg raise test have been suggested to have clinical implications. To understand differences between such leg pain subgroups, and whether differences include potentially modifiable characteristics, the purpose of this paper was to describe characteristics of patients classified into the Quebec Task Force (QTF) subgroups of: 1) LBP only, 2) LBP and pain above the knee, 3) LBP and pain below the knee, and 4) LBP and signs of nerve root involvement. METHODS: Analysis of routine clinical data from an outpatient department. Based on patient reported data and clinical findings, patients were allocated to the QTF subgroups and described according to the domains of pain, activity limitation, work participation, psychology, general health and clinical examination findings. RESULTS: A total of 2,673 patients aged 18-95 years (median 47) who were referred for assessment of LBP were included. Increasing severity was consistently observed across the subgroups from LBP only to LBP with signs of nerve root involvement although subgroup differences were small. LBP patients with leg pain differed from those with LBP only on a wide variety of parameters, and patients with signs of nerve root involvement had a more severe profile on almost all measures compared with other patients with back-related leg pain. CONCLUSION: LBP patients with pain referral to the legs were more severely affected than those with local LBP, and patients with signs of nerve root involvement were the ones most severily affected. These findings underpin the concurrent validity of the Quebec Task Force Classification. However, the small size of many between-subgroup differences amid the large variability in this sample of cross-sectional data also underlines that the heterogeneity of patients with LBP is more complex than that which can be explained by leg pain patterns alone. The implications of the observed differences also require investigation in longitudinal studies.

Classification in nonspecific low back pain: what methods do primary care clinicians currently use?

STUDY DESIGN: Postal survey. OBJECTIVES: To describe the signs and symptoms that clinicians think represent nonspecific low back pain (NSLBP) subgroups, and to report the labels that clinicians give to those subgroups. SUMMARY OF BACKGROUND DATA: The cause of most low back pain (LBP) cannot be diagnosed. Consequently, approximately 80% of primary care LBP presentations are most accurately labeled as NSLBP. Most Australian primary care clinicians think that NSLBP is heterogeneous and treat patients differently based on that heterogeneity. This research sought to identify the subgroups clinicians believe are recognizable within that heterogeneity. METHODS: Analysis of survey data from 651 primary care clinicians from 6 professional disciplines: physiotherapy, manipulative physiotherapy, chiropractic, osteopathy, general medicine, and musculoskeletal medicine. RESULTS: There was little consensus among participating clinicians regarding the signs and symptoms that identify NSLBP subgroups. Most clinicians give labels to NSLBP subgroups that imply putative pathoanatomy, however, the evidence that these labels are valid is scant and controversial. CONCLUSIONS: A lack of consensus among participating clinicians regarding NSLBP subgroups and a lack of evidence for the validity of NSLBP subgrouping are a compelling argument for further research into this clinical practice.

Do primary-care clinicians think that nonspecific low back pain is one condition?

STUDY DESIGN: Postal survey. OBJECTIVES.: To determine whether Australian primary-care clinicians think that nonspecific low back pain (NSLBP) is one condition or a number of conditions (subgroups), and whether this belief influences their management of NSLBP. SUMMARY OF BACKGROUND DATA: Most low back pain (LBP) remains a diagnostic enigma and results in approximately 80% of primary care LBP presentations being most accurately labeled as "nonspecific LBP." Manual therapy clinicians (chiropractors, osteopaths, physiotherapists) are trained to think that subgroups exist within the NSLBP population. This research sought to identify the extent to which these beliefs are widely held in primary care. METHODS: A survey was conducted of 1,093 primary-contact clinicians from six professional disciplines (physiotherapists, manipulative physiotherapists, chiropractors, osteopaths, general medical practitioners, and musculoskeletal medicine practitioners). RESULTS: Completed questionnaires were returned by 651 (60%) clinicians. Of the primary-contact clinicians who responded, 93% do not think NSLBP is one condition. Seventy-four percent think that it is currently possible to recognize NSLBP subgroups. Ninety-three percent treat NSLBP differently based on patterns of signs and symptoms. The proportions of clinicians who hold these views were highest for physiotherapists and manipulative physiotherapists, and smallest for general medical practitioners and musculoskeletal medicine practitioners. CONCLUSIONS: Although assigning NSLBP patients to subgroups has not been validated, it is common in primary-care settings and influences case management. If subgroups exist within the NSLBP population, there are implications for research into the effects of treatment. Further research into the validity of subgroups is warranted.