Pain
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This study describes the minimum incidence of pediatric complex regional pain syndrome (CRPS), clinical features, and treatments recommended by pediatricians and pain clinics in Canada. Participants in the Canadian Paediatric Surveillance Program reported new cases of CRPS aged 2 to 18 years monthly and completed a detailed case reporting questionnaire from September 2017 to August 2019. Descriptive analysis was completed, and the annual incidence of CRPS by sex and age groupings was estimated. ⋯ Referrals most commonly included physical therapy (83.3%) and multidisciplinary pain clinics (72.6%); a small number of patients withdrew from treatment because of pain exacerbation (5.3%). Pain education was recommended for only 65.6% of cases. Treatment variability highlights the need for empiric data to support treatment of pediatric CRPS and development of treatment consensus guidelines.
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Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Researchers and regulators have developed a variety of benefit-risk composite metrics, although the extent to which these methods apply to randomized clinical trials (RCTs) of chronic pain has not been evaluated in the published literature. ⋯ A primary recommendation is that composite metrics of benefit-risk should be combined at the level of the individual patient, when possible, in addition to the benefit-risk assessment at the treatment group level. Both levels of analysis (individual and group) can provide valuable insights into the relationship between benefits and risks associated with specific treatments across different patient subpopulations. The systematic assessment of benefit-risk in clinical trials has the potential to enhance the clinical meaningfulness of RCT results.
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The ability to habituate to pain may be adaptive, and it may enable us to pursue valuable goals despite the pain. In this study, we experimentally investigated this idea using the primary task paradigm in which participants had to identify the color of a circle (blue or yellow) as quickly as possible while ignoring painful or tactile distractors that are presented on some of the trials. In the first experiment, we were interested whether the attentional interference effect because of the presentation of the distractors and its habituation would differ between painful and tactile distractor stimuli. ⋯ Moreover, we did not find evidence for dishabituation. These are the first studies of their kind. Implications and guidelines for future research are formulated.
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A number of studies have demonstrated substantial individual differences in placebo effects. We aimed to identify individual psychological factors that potentially predicted the magnitude of placebo hypoalgesia and individual responsiveness. The Research Domain Criteria framework and a classical conditioning with suggestions paradigm were adopted as experimental models to study placebo phenotypes in a cohort of 397 chronic pain participants with a primary diagnosis of temporomandibular disorder (TMD) and 397 healthy control (HC) participants. ⋯ A greater level of emotional distress was a significant predictor of smaller magnitude (slope b = -0.07) and slower extinction rate (slope b = 0.51) of placebo effects in both TMD and HC participants. Greater reward seeking was linked to greater postconditioning expectations (ie, reinforced expectations) in TMD (slope b = 0.16), but there was no such a prediction in HC participants. These findings highlight that negative valence systems might play a role in impairing placebo effects, with a larger impact in chronic pain participants than in healthy participants, suggesting that individuals reporting emotional distress and maladaptive cognitive appraisals of pain may benefit less from placebo effects.
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We modelled the effects of pain intensity inclusion thresholds (3/10, 4/10, and 5/10 on a 0- to 10-point numerical pain rating scale) on the magnitude of the regression to the mean effect under conditions that were consistent with the sample mean and variance, and intermeasurement correlation observed in clinical trials for the management of chronic pain. All data were modelled on a hypothetical placebo control group. We found a progressive increase in the mean pain intensity as the pain inclusion threshold increased, but this increase was not uniform, having an increasing effect on baseline measurements compared with study endpoint measurements as the threshold was increased. ⋯ At its smallest, the regression to the mean effect was 0.13/10 (95% confidence interval: 0.03/10-0.24/10; threshold: 3/10, baseline mean pain: 6.5/10, SD: 1.6/10, and correlation: 0.44), and at its greatest, it was 0.78/10 (95% confidence interval: 0.63/10-0.94/10; threshold: 5/10, baseline mean pain: 6/10, SD: 1.8/10, and correlation: 0.19). We have shown that using pain inclusion thresholds in clinical trials drives progressively larger regression to the mean effects. We believe that a threshold of 3/10 offers the best compromise between maintaining assay sensitivity (the goal of thresholds) and the size of the regression to the mean effect.