Search

Question: Does feeling reassured after a consultation reduce future disability or healthcare use in people with acute low back pain (LBP)?, Design: Mediation analysis of a randomised, sham-controlled trial., Participants: Two hundred and two people with acute LBP at above average risk (high risk) of developing chronic LBP., Intervention: All participants received guideline-based care from their usual clinician. Participants received two additional 1-hour sessions of patient education focused on emphasising the benign nature of LBP or sham patient education that included active listening only., Outcome Measures: The two primary outcomes for this study were self-reported disability and healthcare use. The mediator was feeling reassured that LBP was not caused by serious illness., Results: Data from 194 (96%) participants and 178 (88%) participants were included in the analysis for disability and healthcare use outcome models, respectively. Feeling reassured did not mediate the effect of the intervention on disability (indirect effect -0.23, 95% CI -0.71 to 0.18) or healthcare use (indirect effect 0.00, 95% CI -0.04 to 0.04). Patient education intervention increased feeling reassured (1.14 points, 95% CI 0.43 to 1.85) compared with sham patient education. However, the mediator (ie, feeling reassured) did not reduce disability (-0.20 points, 95% CI -0.58 to 0.19) or healthcare use (OR 1.09, 95% CI 0.98 to 1.21)., Conclusion: Feeling reassured after a consultation did not lead to improvements in disability and healthcare use for people with acute LBP. Clinicians should reflect on the time that they allocate to reassuring their patients and consider reallocating time to other aspects of the consultation that could reduce disability and future healthcare use., Trial Registration: ACTRN12612001180808, study protocol https://osf.io/4tfaz/., (Copyright © 2021 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

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 Obtaining data from unpublished trials is potentially important because they may impact effect sizes in meta-analyses. We determined whether including unpublished data from trial registries changes the effect sizes in meta-analyses of analgesics for low back pain., Study Design and Setting: Trial registries were searched for unpublished data that conformed to the inclusion criteria of n = 5 individual source systematic reviews.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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Question: What influence do physiotherapists' beliefs and attitudes about chronic low back pain have on their clinical management of people with chronic low back pain?, Design: Systematic review with data from quantitative and qualitative studies. Quantitative and qualitative studies were included if they investigated an association between physiotherapists' attitudes and beliefs about chronic low back pain and their clinical management of people with chronic low back pain., Results: Five quantitative and five qualitative studies were included. Quantitative studies used measures of treatment orientation and fear avoidance to indicate physiotherapists' beliefs and attitudes about chronic low back pain. Quantitative studies showed that a higher biomedical orientation score (indicating a belief that pain and disability result from a specific structural impairment, and treatment is selected to address that impairment) was associated with: advice to delay return to work, advice to delay return to activity, and a belief that return to work or activity is a threat to the patient. Physiotherapists' fear avoidance scores were positively correlated with: increased certification of sick leave, advice to avoid return to work, and advice to avoid return to normal activity. Qualitative studies revealed two main themes attributed to beliefs and attitudes of physiotherapists who have a relationship to their management of chronic low back pain: treatment orientation and patient factors., Conclusion: Both quantitative and qualitative studies showed a relationship between treatment orientation and clinical practice. The inclusion of qualitative studies captured the influence of patient factors in clinical practice in chronic low back pain. There is a need to recognise that both beliefs and attitudes regarding treatment orientation of physiotherapists, and therapist-patient factors need to be considered when introducing new clinical practice models, so that the adoption of new clinical practice is maximised. [Gardner T, Refshauge K, Smith L, McAuley J, Hübscher M, Goodall S (2017) Physiotherapists' beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies. Journal of Physiotherapy 63: 132-143]., (Copyright © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials, achieve only modest improvements in pain, at best. Recently, treatments that target central nervous system function have been developed and tested in small studies. Combining treatments that target central nervous system function with traditional treatments directed towards functioning of the back is a promising approach that has yet to be tested in adequately powered, prospectively registered, clinical trials. The RESOLVE trial will be the first high-quality assessment of two treatment programs that combine central nervous system-directed and traditional interventions in order to improve chronic low back pain., Aim: To compare the effectiveness of two treatment programs that combine central nervous system-directed and traditional interventions at reducing pain intensity at 18 weeks post randomisation in a randomised clinical trial of people with chronic low back pain., Design: Two-group, randomised, clinical trial with blinding of participants and assessors., Participants and Setting: Two hundred and seventy-five participants with chronic low back pain that has persisted longer than 3 months and no specific spinal pathology will be recruited from the community and primary care in Sydney, Australia., Interventions: Both of the interventions contain treatments that target central nervous system function combined with treatments directed towards functioning of the back. Adherence to the intervention will be monitored using an individual treatment diary and adverse events recorded through passive capture. Participants are informed prior to providing informed consent that some of the treatments are not active. Blinding is maintained by not disclosing any further information. Complete disclosure of the contents of the intervention has been made with the UNSW HREC (HC15357) and an embargoed project registration has been made on the Open Science Framework to meet the Declaration of Helsinki requirement for transparent reporting of trial methods a priori., Intervention a: Participants randomised to Intervention A will receive a 12-session treatment program delivered as 60-minute sessions, scheduled approximately weekly, over a period of 12 to 18 weeks. All treatment sessions are one-on-one. The program includes a home treatment component of 30minutes, five times per week. The intervention comprises discussion of the participant's low back pain experience, graded sensory training, graded motor imagery training and graded, precision-focused and feedback-enriched, functional movement training. Treatment progression is determined by participant proficiency, with mandatory advancement at set time points with respect to a standard protocol., Intervention B: Participants randomised to Intervention B will receive a 12-session treatment program of the same duration and structure as Intervention A. The intervention comprises discussion of the participant's low back pain experience, transcranial direct current stimulation to the motor and pre-frontal cortices, cranial electrical stimulation, and low-intensity laser therapy and pulsed electromagnetic energy to the area of greatest pain. Treatment is delivered according to published recommendations and progressed with respect to a standard protocol., Measurements: The primary outcome is pain intensity at 18 weeks post randomisation. Secondary outcomes will include disability, depression, pain catastrophising, kinesiophobia, beliefs about back pain, pain self-efficacy, quality of life, healthcare resource use, and treatment credibility. Assessment will occur at baseline and at 18, 26 and 52 weeks after randomisation. Treatment credibility will be assessed at baseline and 2 weeks after randomisation only., Analysis: A statistician blinded to group status will analyse the data by intention-to-treat using linear mixed models with random intercepts. Linear contrasts will be constructed to compare the adjusted mean change (continuous variables) in outcome from baseline to each time point between intervention A and intervention B. This will provide effect estimates and 95% confidence intervals for any difference between the interventions., Significance: Preliminary data suggest that combining treatments that target central nervous system function with traditional interventions is a promising approach to chronic low back pain treatment. In the context of modest effects on pain intensity from most available treatments, this approach may lead to improved clinical outcomes for people with chronic low back pain. The trial will determine which, if either, of two treatment programs that combine central nervous system-directed and traditional interventions is more effective at reducing pain intensity in a chronic low back pain cohort. Central nervous system-directed interventions constitute a completely new treatment paradigm for chronic low back pain management. The results have the potential to be far reaching and change current physiotherapy management of chronic low back pain in Australia and internationally., (Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

Objective: Professional appearance is easily modifiable, and might alter the effects of a clinical encounter. We aimed to determine whether professional attire influences a patient's perception of treatment credibility., Methods: We performed a single-blind randomized controlled study on 128 patients with acute non-specific low back pain who were about to receive treatment in primary care. The treating clinician was randomly allocated to wear formal attire (experimental condition) or casual attire (control condition) to the consultation. Clinicians provided a standardized briefing on the rationale behind the patient's forthcoming treatment. Treatment credibility (Credibility and Expectancy Questionnaire) was assessed immediately after this briefing., Results: All patients received the experimental or control condition as allocated and provided complete primary outcome data. Formal attire had no effect on perceived treatment credibility (Mean difference between groups 1.2 [95%CI-1.1 to 3.5]). Age was the only significant predictor of treatment credibility; older patients rated treatment credibility higher (Beta=0.16 [95%CI 0.08 to 0.24])., Conclusion: In a trial setting, whether or not a clinician is formally dressed has no effect on perceptions of treatment credibility in patients with acute low back pain., Practice Implication: Clinicians should dress comfortably without fear of losing credibility., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objective: To determine the extent of alignment between clinical outcome measures and patient-derived goals for the management of chronic low back pain (cLBP)., Methods: A customised, patient-led goal setting intervention was implemented facilitated by a physiotherapist, in which participants identified problem areas and developed strategies to address them. Patient goals were compared to the most commonly used outcome measures in cLBP as well as research outcomes recommended by the IMMPACT consortium., Results: From 20 participants, a total of 27 unique goals were identified, the most common goal related to physical activity (49%). Comparison of participant goals to the most common measures used by physiotherapists found none of the goals could be aligned. Comparison of goals and domains with IMPACCT outcome domains found 76% of the goals were aligned with physical functioning and 16% with emotional functioning., Conclusion: This study has identified goals important to patients in cLBP, these were varied, and most did not correspond with current clinical measures., Practice Implications: Clinical outcome measures may not be providing accurate information about the success of treatments that are meaningful to the patient. Clinicians should consider a collaborative approach with cLBP patients to determine treatment interventions that are driven by patient preference., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Introduction: Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions., Aim: To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs., Design: Causal mediation analysis of the PREVENT randomised controlled trial., Participants and Setting: Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area., Intervention: Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group)., Measurements: All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain., Analysis: Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference., Discussion and Significance: Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain., (Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)