Predicting outcome in acute low back pain using different models of patient profiling

Study Design: Prospective observational study of prognostic indicators, utilising data from a randomised, controlled trial of physiotherapy care of acute low back pain (ALBP) with follow up at 6 weeks, 3 months and 6 months. Objective: To evaluate which patient profile offers the most useful guide to long-term outcome in ALBP. Summary of Background Data: The evidence used to inform prognostic decision-making is derived largely from studies where baseline data is used to predict future status. Clinicians often see patients on multiple occasions so may profile patients in a variety of ways. It is worth considering if better prognostic decisions can be made from alternative profiles. Methods: Clinical, psychological and demographic data were collected from a sample of 54 ALBP patients. Three clinical profiles were developed from information collected at baseline, information collected at 6 weeks, and the change in status between these two time points. A series of regression models were used to determine the independent and relative contributions of these profiles to the prediction of chronic pain and disability. Results: The baseline profile predicted long-term pain only. The 6-week profile predicted both long-term pain and disability. The change profile only predicted long-term disability (p \u3c 0.01). When predicting long-term pain, after the baseline profile had been added to the model, the 6-week profile did not add significantly when forced in at the second step (p \u3e 0.05). A similar result was obtained when the order of entry was reversed. When predicting long-term disability, after the 6-week profile was entered at the first step, the change profile was not significant when forced in at the second step. However, when the change profile was entered at the first step and the 6-week clinical profile was forced in at the second step, a significant contribution of the 6-week profile was found. Conclusions: The profile derived from information collected at 6 weeks provided the best guide to long-term pain and disability. The baseline profile and change in status offered less predictive value

International low back pain guidelines: A comparison of two research based models of care for the management of acute low back pain.

Evidence based guidelines for the management of acute low back pain (ALBP) have been formulated by numerous countries. There are discrepancies between guidelines regarding physiotherapy treatment. The aim of this study was to compare two research based models derived from international LBP guidelines. A single-blind randomised controlled trial was undertaken in a physiotherapy outpatients department. Subjects with ALBP were randomly allocated to an ‘assess/advise/treat’ group (n = 50) or an ‘assess/advise/wait’ group (n = 52). The primary outcome measure was the Roland and Morris Disability Questionnaire (RMDQ). Secondary outcome measures of pain (VAS, usual pain intensity) depressive symptoms (MZSRDS) somatic distress (MSPQ) anxiety (STAIS) quality of life (SF36) and general health (EuroQol) were also obtained. Outcomes were assessed at 6-weeks, 3-months and 6-months. At 6-weeks subjects in the assess/advise/treat group demonstrated less LBP related disability (p = 0.02) and depressive symptoms (p = 0.01), as well as better general health (p = 0.006, p = 0.05), vitality (p \u3c 0.001), social functioning (p = 0.004) and mental health (p = 0.002). At long-term assessment (3 and 6 months) subjects in the assess/advise/treat group were less distressed (p = 0.004), anxious (p = 0.01) and had fewer depressive symptoms (p = 0.001), as well as reporting better general health (p = 0.009, p = 0.05), emotional role (p = 0.03) and mental health (p = 0.04). Active physiotherapy produces better short-term outcomes than advice. Delaying treatment has no long-term consequences on pain or disability, but affects the development of psychosocial features

Optimising physiotherapy care for acute low back pain – identifying non-responders to treatment

Recent evidence suggests that positive effects of physiotherapy for acute low back pain patients can be achieved if treatment is delivered early enough. However it is clear that not all patients treated with physiotherapy are likely to report equally positive outcomes from their treatment. The identification of clinical characteristics of those patients who do less well will help refine models of care for acute low back pain. Aim: To identify non-responders to early active physiotherapy. Method: A secondary analysis was conducted on the data from a recently published randomised controlled trial of early physiotherapy for acute low back pain. All patients were randomised into two groups: immediate physiotherapy or advice and wait list and completed a series of physical, psychological and pain measures at baseline and again at six weeks. Multivariate statistical analysis was conducted to identify which patient baseline characteristics were associated with unsuccessful outcomes at the six week follow up. Control group comparisons permitted only those relationships associated with the intervention to be described. Results: Data analysis indicated that subgroups of patients who responded poorly to their physiotherapy treatment could be identified by a priori knowledge of their pain, mental health and physical function (p\u3c0.05). Conclusions: The results of the current analysis suggest that there are identifiable subgroups of patients who respond less well to physiotherapy treatment. Attention to these patient characteristics needs to be included in models of care for acute low back pain so that effects of therapy for all patients can be optimised

Recent data from radiofrequency denervation trials further emphasise that treating nociception is not the same as treating pain

Chronic low back pain is a condition that current health care provision is failing and we suggest that recent evidence from the interventional pain medicine field points to what these failings are. Radiofrequency denervation is performed on the presumption that denervation of a peripheral structure will eradicate or significantly reduce pain and improve function. The results of six moderately sized and well conducted clinical trials that demonstrate no efficacy and no real-world effectiveness for denervation procedures are a stark illustration of how flawed this approach is. We suggest that these results represent a line-in-the-sand for back pain research and management. This is a clear signal to finally abandon research agendas and management paradigms that focus primarily on nociception and instead, truly embrace the biopsychosocial model of pain

Early intervention for the management of acute low back pain: A single blind randomised controlled trial of biopsychosocial education, manual therapy and exercise

Design: A single blind randomised controlled trial comparing two models of care for patients with simple acute low back pain (ALBP). Objectives: To compare two research-based models of care for ALBP, and investigate the effect of the timing of physical intervention. Summary of Background Data National guidelines offer conflicting information on the delivery of physical treatment in the management of ALBP. Review of guidelines suggests two different models of care. Direct comparisons between these models are lacking in the literature. The present study aims to compare these two approaches to the management of ALBP. Method: Among 804 referred patients, 102 subjects met the specific admission criteria and were randomly assigned to an ‘assess/advise/treat’ group or an ‘assess/advise/wait’ group. The intervention consisted of biopsychosocial education, manual therapy and exercise. Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active. Assessment of long-term outcome enables comparison to be made between early and late intervention. Study outcomes of reported pain (VAS), functional disability (RMDQ), mood (MZSRDS, MSPQ, STAIS), general health (Euroqol) and quality of life (SF-36) were assessed at baseline, six weeks, three months and six months. Results: At six weeks, the ‘assess/advise/treat’ group demonstrated greater improvements in disability, mood, general health and quality of life than patients in the ‘assess/advise/wait’ group (p0.05). However, mood, general health and quality of life remained significantly better in the ‘assess/advise/treat’ group (p\u3c0.05). Conclusions: At six weeks physiotherapy intervention is more effective than advice on staying active, leading to more rapid improvement in function, mood, quality of life and general health. The timing of intervention affects the progression of psychosocial features. If treatment is provided later, the same psychosocial benefits are not achieved. Therefore an \u27assess/advise/treat\u27 model of care seems to offer better outcomes than an \u27assess/advise/wait\u27 model of care

Movement restriction does not modulate sensory and perceptual effects of exercise-induced arm pain

BACKGROUND: Movement restriction has been proposed as an important modulator of changes in sensory and perceptual function and motor imagery performance that are observed in musculoskeletal pain syndromes. There are no empirical data to support this view. PURPOSE: The primary objective of this experiment was to determine the effects of movement restriction on local and widespread sensory, perceptual and motor imagery changes after exercise-induced muscular pain. Further objectives were to investigate whether changes in sensory perception are correlated with pain intensity and tactile acuity or motor imagery performance. METHODS: In forty healthy volunteers, delayed onset muscle soreness (DOMS) of the non-dominant elbow flexors was induced using eccentric contractions until exhaustion. Participants were then randomised into two groups: a movement restriction group (wearing a sling) or a control group (not wearing a sling). Sensory and perceptual functions were measured using a range of sensory tests and a motor imagery performance task (left/right limb judgements). RESULTS: Movement restriction did not modulate any of the measures. We found concurrent mechanical hypoesthesia (p \u3c 0.01), reduced tactile acuity (p = 0.02) and pressure hyperalgesia (p \u3c 0.01) at the painful side. We found evidence of widespread pressure hyperalgesia. Impaired tactile acuity was associated with a decrease in pain threshold to pressure (r = -0.34, p = 0.03). Motor imagery performance was unchanged (p \u3e 0.35) by pain or movement restriction. CONCLUSION: Short-term movement restriction did not influence local and widespread sensory changes induced by experimentally induced muscular pain

Reviews may overestimate the effectiveness of medicines for back pain: Systematic review and meta-analysis

Objective: Systematic-reviews of analgesics for low back pain generally include published data only. Obtaining data from unpublished trials is potentially important because they may impact effect sizes in meta-analyses. We determined whether including unpublished data from trial registries changes the effect sizes in meta-analyses of analgesics for low back pain. Study Design and Setting: Trial registries were searched for unpublished data that conformed to the inclusion criteria of n=5 individual source systematic-reviews. We reproduced the meta-analyses using data available from the original reviews then re-ran the same analyses with the addition of new unpublished data. Results: Sixteen completed, unpublished, trials were eligible for inclusion in four of the source reviews. Data were available for five trials. We updated the analyses for two of the source reviews. The addition of data from two trials reduced the effect size of muscle relaxants, compared to sham, for recent-onset low back pain from -21.71 (95%CI -28.23 to -15.19) to -2.34 (95%CI -3.34 to -1.34) on a 0-100 scale for pain intensity. The addition of data from three trials (one enriched design) reduced the effect size of opioid analgesics, compared to sham, for chronic low back pain from -10.10 (95%CI -12.81 to -7.39) to -9.31 (95%CI -11.51 to -7.11). The effect reduced in the subgroup of enriched design studies, from -12.40 (95%CI -16.90 to -7.91) to 11.34 (95%CI -15.36 to -7.32), and in the subgroup of non-enriched design studies; from -7.27 (95%CI -9.97 to -4.57) to -7.19 (95%CI -9.24 to -5.14). Conclusion: Systematic-reviews should include reports of unpublished trials. The result for muscle relaxants conflicts with the conclusion of the published review and recent international guidelines. Adding unpublished data strengthens the evidence that opioid analgesics have small effects on persistent low back pain and more clearly suggests these effects may not be clinically meaningful

Systematic reviews that include only published data may overestimate the effectiveness of analgesic medicines for low back pain: A systematic review and meta-analysis

Objective: Systematic reviews of analgesics for low back pain generally include published data only. Obtaining data from unpublished trials is potentially important because they may impact effect sizes in meta-analyses. We determined whether including unpublished data from trial registries changes the effect sizes in meta-analyses of analgesics for low back pain. Study Design and Setting: Trial registries were searched for unpublished data that conformed to the inclusion criteria of n = 5 individual source systematic reviews. We reproduced the meta-analyses using data available from the original reviews and then reran the same analyses with the addition of new unpublished data. Results: Sixteen completed, unpublished, trials were eligible for inclusion in four of the source reviews. Data were available for five trials. We updated the analyses for two of the source reviews. The addition of data from two trials reduced the effect size of muscle relaxants, compared with sham, for recent-onset low back pain from −21.71 (95% CI: −28.23 to −15.19) to −2.34 (95% CI: −3.34 to −1.34) on a 0–100 scale for pain intensity. The addition of data from three trials (one enriched design) reduced the effect size of opioid analgesics, compared with sham, for chronic low back pain from −10.10 (95% CI: −12.81 to −7.39) to −9.31 (95% CI: −11.51 to −7.11). The effect reduced in the subgroup of enriched design studies, from −12.40 (95% CI: −16.90 to −7.91) to −11.34 (95% CI: −15.36 to −7.32), and in the subgroup of nonenriched design studies, from −7.27 (95% CI: −9.97 to −4.57) to −7.19 (95% CI: −9.24 to −5.14). Conclusion: Systematic reviews should include reports of unpublished trials. The result for muscle relaxants conflicts with the conclusion of the published review and recent international guidelines. Adding unpublished data strengthens the evidence that opioid analgesics have small effects on persistent low back pain and more clearly suggests these effects may not be clinically meaningful

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617]

BACKGROUND: Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain. METHODS/DESIGN: This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain

Is there a causal relationship between acute stage sensorimotor cortex activity and the development of chronic low back pain? : a protocol and statistical analysis plan

Introduction: Why some people develop chronic pain following an acute episode of low back pain is unknown. Recent cross-sectional studies have suggested a relationship between aberrant sensorimotor cortex activity and pain persistence. The UPWaRD (Understanding persistent Pain Where it ResiDes) cohort study is the first prospective, longitudinal investigation of sensorimotor cortex activity in low back pain. This paper describes the development of a causal model and statistical analysis plan for investigating the causal effect of sensorimotor cortex activity on the development of chronic low back pain. Methods and analysis: Sensorimotor cortex activity was assessed within 6 weeks of low back pain onset using somatosensory evoked potentials and transcranial magnetic stimulation mapping techniques. Chronic low back pain is defined as ongoing pain (Numerical Rating score ≥1) or disability (Roland Morris Disability Questionnaire score ≥3) at 6 months follow-up. Variables that could confound the relationship between sensorimotor cortex activity and chronic low back pain were identified using a directed acyclic graph and content expertise was used to specify known causal paths. The statistical model was developed ‘a priori’ to control for confounding variables identified in the directed acyclic graph, allowing an unbiased estimate of the causal effect of sensorimotor activity in acute low back pain on the development of chronic pain. The statistical analysis plan was finalised prior to follow-up of all participants and initiation of analysis. Ethics and dissemination: Ethical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals. Trial registration number: ACTRN12619000002189 (retrospectively registered)