The journal of pain : official journal of the American Pain Society
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Initial content validation and roadmap for a new patient-reported outcome measure of pain intensity.
Measures of pain intensity (eg, numeric rating scales [NRS]) are widely used in clinical research and practice. While these measures have evidence for validity and reliability, poor standardization of instructions, and response options limits precision of pain assessment, allows for inconsistency in interpretation, and presents a challenge for comparison and aggregation of study results. Despite these pitfalls, the 0 to 10 NRS remains the most commonly used primary outcome measure in clinical trials of pain treatments and is the core measure recommended by regulatory agencies. ⋯ This article summarizes interview findings, describes how patient input and FDA feedback informed preliminary candidate measures, and provides an overview of the FDA qualification process. PERSPECTIVE: Concept elicitation interviews informed the development of content-valid candidate measures of acute and chronic pain intensity for planned use in clinical trials of pain treatments, and comprise the initial stage in FDA clinical outcome assessment qualification. Measures will subsequently be evaluated through cognitive interviews and a series of psychometric studies.
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Despite a rapid expansion of cannabis use for pain management, how cannabis and prescription opioids are co-used and whether co-use improves analgesia and promotes reduction of opioid use in the daily lives of individuals with chronic pain is poorly understood. Based upon ecological momentary assessment (EMA), the present study examined 1) how pain and use of opioids and/or cannabis in the previous moment is associated with individuals' choice of opioids and/or cannabis in the next moment, 2) the effects of co-use on pain severity and pain relief, and 3) whether daily total opioid consumption differs on days when people only used opioids versus co-used. Adults with chronic pain (N = 46) using both opioids and cannabis who were recruited online completed a 30-day EMA. ⋯ PERSPECTIVE: This article presents the overall patterns and effects of co-using cannabis and prescription opioids among individuals with chronic pain employing ecological momentary assessment. There were conflicting findings on the association between co-use and analgesia. Co-use was not associated with a reduction in daily opioid consumption in this sample.
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Observational Study
Profiles of Pain Acceptance and Values-Based Action in the Assessment and Treatment of Chronic Pain.
Pain acceptance and values-based action are relevant to treatment outcomes in those with chronic pain. It is unclear if patterns of responding in these 2 behavioral processes can be used to classify patients into distinct classes at treatment onset and used to predict treatment response. This observational cohort study had 2 distinct goals. ⋯ In the smaller treated sample, participants in the Low AV and Moderate AV class demonstrated improvements across all outcome variables, whereas those in the High AV class did not. These findings support the role of pain acceptance and values-based action in those with chronic pain. PERSPECTIVE: Individuals with chronic pain can be classified with respect to pain acceptance and values-based action and these groups may respond differently to treatment.
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To calibrate or not to calibrate? This question is raised by almost everyone designing an experimental pain study with supra-threshold stimulation. The dilemma is whether to individualize stimulus intensity to the pain threshold / supra-threshold pain level of each participant or whether to provide the noxious stimulus at a fixed intensity so that everyone receives the identical input. Each approach has unique pros and cons which need to be considered to i) accurately design an experiment, ii) enhance statistical inference in the given data and, iii) reduce bias and the influence of confounding factors in the individual study e.g., body composition, differences in energy absorption and previous experience. ⋯ PERSPECTIVE: To calibrate pain or not? This dilemma is related to almost every experimental pain research. The decision is a trade-off between statistical power and greater control of stimulus encoding. The article decomposes both approaches and presents the pros and cons of either approach supported by data and simulation experiment.
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Physical activity can improve function in patients with chronic pain, however, adherence is low, in part due to inconsistent activity patterns. Smart wearable activity trackers, such as Fitbits, may help promote activity. In our program for chronic pain, we examined: 1) Fitbit activity patterns (ie, step count, moderate-to-vigorous physical activity (MVPA), sedentary behavior), and 2) whether achievement of weekly, individualized Fitbit step goals was associated with functional outcomes. ⋯ Adhering to individualized Fitbit step goals in the context of a mind-body activity program may improve anxiety and self-reported and performance-based physical function. PERSPECTIVE: We examine Fitbit activity patterns and the association between quota-based pacing and functional outcomes within a mind-body activity program for adults with chronic pain. Complementing quota-based pacing and coping skills with Fitbits may be a useful approach to promote activity engagement and behavior change in chronic pain populations.