The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
A longitudinal randomized trial of the impact of consistent pain management for infant vaccinations on future vaccination distress.
The objective was to determine if consistent pain management during vaccine injections has a beneficial effect on future infant pain reactivity. This was a multicenter, longitudinal, double-blind, double-dummy, add-on, randomized controlled trial. Healthy infants were randomized to 1 of 4 add-on pain management regimens for all vaccinations in the first year of life: 1) placebo control (standard care), 2) parent video education about infant soothing (video), 3) video and oral sucrose solution (sucrose), 4) video and sucrose and topical liposomal lidocaine (lidocaine). ⋯ Altogether, 352 infants participated; characteristics did not differ among groups (P > .05). Pain scores did not differ among groups during baseline (P = .642), needle injection (P = .739), or recovery (P = .750) phases. In conclusion, there was no evidence of a long-term benefit of consistent use of pain interventions in the first year of life on future infant pain responsivity at 15-month vaccinations.
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Claims are made for the validity of some self-report pain scales for 3- and 4-year-old children, but little is known about their ability to use such tools. This systematic review identified self-report pain intensity measures used with 3- and/or 4- year-old participants (3-4yo) and considered their reliability and validity within this age span. The search protocol identified research articles that included 3-4yo, reported use of any pain scale, and included self-reported pain intensity ratings. A total of 1,590 articles were screened and 617 articles met inclusion criteria. Of the included studies, 98% aggregated self-report data for 3-4yo with data for older children, leading to overestimates of the reliability and validity of self-report in the younger age group. In the 14 studies that provided nonaggregated data for 3-4yo, there was no evidence for 3-year-old and weak evidence for 4-year-old children being able to use published self-report pain intensity tools in a valid or reliable way. Preschool-age children have been reported to do better with fewer than the 6 response options offered on published faces scales. Simplified tools are being developed for young children; however, more research is needed before these are adopted. ⋯ Some self-report pain scales have been promoted for use with 3- and 4-year-old children, but this is on the basis of studies that aggregated data for younger and older children, resulting in overestimates of reliability and validity for the preschool-age children. Scales with fewer response options show promise, at least for 4-year-old children.
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Randomized Controlled Trial Multicenter Study
OPRM1 Methylation Contributes to Opioid Tolerance in Cancer Patients.
Cancer patients in pain require high doses of opioids and quickly become opioid-tolerant. Previous studies have shown that chronic cancer pain as well as high-dose opioid use lead to mu-opioid receptor downregulation. In this study we explore downregulation of the mu-opioid receptor gene (OPRM1), as a mechanism for opioid tolerance in the setting of opioid use for cancer pain. ⋯ We focus on 2 main cells within the cancer microenvironment: the cancer cell and the neuron. We show that targeted re-expression of mu-opioid receptor on cancer cells inhibits mechanical and thermal hypersensitivity, and prevents opioid tolerance, in the mouse model. The resultant analgesia and protection against opioid tolerance are likely due to preservation of mu-opioid receptor expression on the cancer-associated neurons.
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Observational Study
Development and Validation of a Daily Pain Catastrophizing Scale.
To date, there is no validated measure for pain catastrophizing at the daily level. The Pain Catastrophizing Scale (PCS) is widely used to measure trait pain catastrophizing. We sought to develop and validate a brief, daily version of the PCS for use in daily diary studies to facilitate research on mechanisms of catastrophizing treatment, individual differences in self-regulation, and to reveal the nuanced relationships between catastrophizing, correlates, and pain outcomes. After adapting the PCS for daily use, we evaluated the resulting 14 items using 3 rounds of cognitive interviews with 30 adults with chronic pain. We refined and tested the final daily PCS in 3 independent, prospective, cross-sectional, observational validation studies conducted in a combined total of 519 adults with chronic pain who completed online measures daily for 14 consecutive days. For study 1 (N = 131), exploratory factor analysis revealed adequate fit and-unexpectedly-unidimensionality for item responses to the daily PCS. Study 2 (N = 177) correlations indicated adequate association with related constructs (anger, anxiety, pain intensity, depression). Similarly, results for study 3 (N = 211) revealed expected correlations for daily PCS and measures of daily constructs including physical activity, sleep, energy level, and positive affect. Results from complex/multilevel confirmatory factor analysis confirmed good fit to a unidimensional model. Scores on the daily PCS were statistically comparable with and more parsimonious than the full 14-item version. Next steps include evaluation of score validity in populations with medical diagnoses, greater demographic diversity, and in patients with acute pain. ⋯ This article describes the development and validation of a daily PCS. This daily measure may facilitate research that aims to characterize pain mechanisms, individual differences in self-regulation, adaptation, and nuanced relationships between catastrophizing, correlates, and pain outcomes.
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Randomized Controlled Trial
Responsiveness and Minimally Important Differences for Four Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis.
Patient-Reported Outcomes Measurement Information System (PROMIS) instruments can provide valid, interpretable measures of health status among adults with osteoarthritis (OA). However, their ability to detect meaningful change over time is unknown. We evaluated the responsiveness and minimally important differences (MIDs) for 4 PROMIS Short Forms: Physical Function, Pain Interference, Depression, and Anxiety. We analyzed adults with symptomatic knee OA from our randomized trial comparing Tai Chi and physical therapy. Using baseline and 12-week scores, responsiveness was evaluated according to consensus standards by testing 6 a priori hypotheses of the correlations between PROMIS and legacy change scores. Responsiveness was considered high if ≥5 hypotheses were confirmed, and moderate if 3 or 4 were confirmed. MIDs were evaluated according to prospective change for people achieving previously-established MID on legacy comparators. The lowest and highest MIDs meeting a priori quality criteria formed a MID range for each PROMIS Short Form. Among 165 predominantly female (70%) and white (57%) participants, mean age was 61 years and body mass index was 33. PROMIS Physical Function had 5 confirmed hypotheses and Pain Interference, Depression, and Anxiety had 3 or 4. MID ranges were: Depression = 3.0 to 3.1; Anxiety = 2.3 to 3.4; Physical Function = 1.9 to 2.2; and Pain Interference = 2.35 to 2.4. PROMIS Physical Function has high responsiveness, and Depression, Anxiety, and Pain Interference have moderate responsiveness among adults with knee OA. We established the first MIDs for PROMIS in this population, and provided an important standard of reference to better apply or interpret PROMIS in future trials or clinical practice. ⋯ This study examined whether PROMIS Short Form instruments (Physical Function, Pain Interference, Depression, and Anxiety) were able to detect change over time among adults with knee OA, and provided minimally important change estimates for each measure. This standard of reference can help apply or interpret these instruments in the future.