Pain
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Randomized Controlled Trial
Mechanisms of education and graded sensorimotor retraining in people with chronic low back pain: a mediation analysis.
An improved understanding of the biopsychosocial influences that contribute to and maintain pain has promoted the development of new efficacious treatments for chronic low back pain (CLBP). This study aimed to investigate the mechanisms of a new treatment-education and graded sensorimotor retraining-on pain and disability. We conducted a preplanned causal mediation analysis of a randomized clinical trial which allocated 276 participants with CLBP to 12 weekly clinical sessions of education and graded sensorimotor retraining (n = 138) or a sham and attention control (n = 138). ⋯ Five of 7 mechanisms (71%) mediated the intervention effect on disability; the largest mediated effects were for beliefs about back pain consequences (-1.66 [-2.62 to -0.87]), pain catastrophizing (-1.06 [-1.79 to -0.53]), and pain self-efficacy (-0.84 [-1.89 to -0.45]). When all 7 mechanisms were considered simultaneously, the joint mediation effect explained most of the intervention effect for both pain and disability. Optimizing interventions to target beliefs about the consequences of back pain, pain catastrophizing, and pain self-efficacy is likely to lead to improved outcomes for people with CLBP.
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Randomized Controlled Trial
STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy.
Because long-term opioid therapy (LtOT) for chronic pain has uncertain benefits and dose-dependent harms, safe and effective strategies for opioid tapering are needed. Adapting a promising pilot study intervention, we conducted the STRategies to Improve Pain and Enjoy life (STRIPE) pragmatic clinical trial. Patients in integrated health system on moderate-to-high dose of LtOT for chronic noncancer pain were randomized individually to usual care plus intervention (n = 79) or usual care only (n = 74). ⋯ We did not observe significant differences between intervention and usual care for MME (adjusted mean difference: -2.3 MME; 95% confidence interval: -10.6, 5.9; P = 0.578), the Pain, Enjoyment of Life, General Activity scale (0.0 [95% confidence interval: -0.5, 0.5], P = 0.985), or most secondary outcomes. The intervention did not lower opioid dose or improve pain or functioning. Other strategies are needed to reduce opioid doses while improving pain and function for patients who have been on LtOT for years with high levels of medical, mental health, and substance use comorbidity.
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Randomized Controlled Trial Multicenter Study
Implementation of a risk-stratified, guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT): a multicentre, randomized, controlled trial.
Current pathways of care for whiplash follow a "stepped care model," result in modest treatment outcomes and fail to offer efficient management solutions. This study aimed to evaluate the effectiveness of a risk-stratified clinical pathway of care (CPC) compared with usual care (UC) in people with acute whiplash. We conducted a multicentre, 2-arm, parallel, randomised, controlled trial in primary care in Australia. ⋯ Baseline risk category did not modify the effect of treatment. No adverse events were reported. Risk-stratified care for acute whiplash did not improve patient outcomes, and implementation of this CPC in its current form is not recommended.
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Randomized Controlled Trial
Reductions in kinesiophobia and distress after pain neuroscience education and exercise lead to favourable outcomes: a secondary mediation analysis of a randomized controlled trial in primary care.
Pain neuroscience education combined with exercise (PNE + exercise) is an effective treatment for patients with chronic spinal pain. Yet, however, little is known about its underlying therapeutic mechanisms. Thus, this study aimed to provide the first insights by performing a novel mediation analysis approach in a published randomized controlled trial in primary care where PNE + exercise was compared with standard physiotherapy. ⋯ Changes in catastrophizing and pain intensity did not mediate improvements in any outcome. The mediation analyses with mediator-mediator interactions suggested a potential effect modification rather than causal independence among the mediators. The current results, therefore, support the PNE framework to some extent as well as highlight the need for implementing the recent approaches for mediation analysis to accommodate dependencies among the mediators.
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Randomized Controlled Trial
Placebo effects contribute to brief online mindfulness interventions for chronic pain: results from an online randomized sham-controlled trial.
Mindfulness apps are becoming popular treatments for chronic pain and mental health, despite mixed evidence supporting their efficacy. Furthermore, it is unclear whether improvements in pain are due to mindfulness-specific effects or placebo effects because no trials have compared mindfulness against a sham control. The objective of this study was to compare mindfulness against 2 sham conditions with differing proximity to mindfulness to characterize the relative contributions of mindfulness-specific and nonspecific processes on chronic pain. ⋯ These findings suggest that improvements in chronic pain unpleasantness following a single session of online-delivered mindfulness meditation may be driven by placebo effects. Nonspecific treatment effects including placebo expectancy and pain catastrophizing may drive immediate pain attenuation rather than theorized mindfulness-specific processes themselves. Further research is needed to understand whether mindfulness-specific effects emerge after longer durations of online training.