Pain Reports最新文献

Introduction: The primary objective of this cross-sectional analysis is to evaluate rates of discontinuation and nonpublication of Randomized controlled trials (RCTs) of therapeutic interventions to treat chronic pain.

Methods: Using ClinicalTrials.gov, a sample was obtained which included clinical trials pertaining to chronic pain. Trials were analyzed for publication status and completion status of each trial. If information was unavailable on the trial registry database, or could not be allocated through a systematic search, the corresponding trialist was contacted and data points were gathered.

Results: In our final analysis of the 408 RCTs, we found that 281 (68.9%) were published in a peer-reviewed journal and 127 (31.1%) were unpublished trials. Of 112 discontinued trials, 59 (52.7%) reached publication. In addition, 221 of 296 completed trials (74.7%) were published, and 75 (25.3%) remained unpublished after trial completion. The most common listed reason for trial discontinuation was administrative recommendations (41 of 71 trials [57.7%]), while not receiving an email reply to our standardized email from the corresponding trialist was the most common result for trial nonpublication (49 of 88 trials [55.7%]). Clinical trials funded by nonindustry sponsors were more likely to reach publication than industry-funded clinical trials (unadjusted odds ratio 1.86 [95% CI, 1.18-2.95]; adjusted odds ratio 3.01 [95% CI, 1.76-5.14]).

Conclusion: The rate of discontinuation of RCTs involving patients with chronic pain is concerning. Chronic pain affects many patients; thus, the importance of having quality data from clinical trials cannot be overstated. Our study indicates that chronic pain RCTs are frequently discontinued and their findings often go unpublished - all of which could provide crucial information to providers and patients regarding the treatment of chronic pain. We offer suggestions to enhance chronic pain RCT completion, thereby reducing the waste of resources in chronic pain research.

Introduction: Pain-related fear, anxiety, and avoidance may play key roles in the chronification of pain and related disability. For practitioners, knowledge about the source or drivers of these fears, including patients' exposure to potentially traumatic events (PTEs) and related posttraumatic stress symptoms, could be particularly helpful in guiding their treatment approach.

Objectives: We aimed to investigate whether the use of a brief screening for PTEs could help inform chronic pain treatment.

Methods: The performance and acceptability of the Stressful Life Events Screening Questionnaire (SLESQ) was assessed among 567 adult patients (59% women, mean age 48.1 years) meeting at a hospital outpatient pain clinic. The sensitivity, specificity, and 20 months temporal stability of the SLESQ, assessing exposure to 14 specific trauma types followed by a 15th item capturing exposure to "other events," were assessed through digital administration and follow-up interviews with 55 participants. The qualitative responses of 158 participants reporting exposure to "other events" were reviewed and assessed based on fulfillment of the A Criterion for traumatic events in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The acceptability of the SLESQ was assessed in clinical interviews with 12 participants.

Results: The SLESQ demonstrated acceptable sensitivity (70.0%), high specificity (94.9%), and moderate temporal stability (κ = 0.66, P < 0.001). Participants' qualitative elaborations of "other events" were largely (76.3%) consistent with Criterion A events. The screening was well accepted and welcomed.

Conclusion: The results indicate that the use of a brief screening for potential trauma may be helpful to guide clinical practice in chronic pain settings.

Introduction: Given the challenges health systems face in providing effective nonpharmacologic treatment for pain and psychological distress, clinical effectiveness studies of evidence-based strategies such as music therapy (MT) are needed.

Objectives: This study examined changes in patient-reported outcomes (PROs) after MT and explored variables associated with pain reduction of ≥2 units on a 0 to 10 numeric rating scale (NRS).

Methods: A retrospective review was conducted on initial MT interventions provided to adults receiving community hospital care between January 2017 and July 2020. Sessions were included if participants reported pre-session pain, anxiety, and/or stress scores of ≥4 on the NRS. Data analysis included a bootstrap analysis of single-session changes in PROs and a logistic regression exploring variables associated with pain reduction (ie, ≥2 units vs <2 units).

Results: Patients (n = 1056; mean age: 63.83 years; 76.1% female; 57.1% White; 41.1% Black/African American) reported clinically significant mean reductions in pain (2.04 units), anxiety (2.80 units), and stress (3.48 units). After adjusting for demographic, clinical, and operational characteristics in the model (c-statistic = 0.668), patients receiving an MT session in which pain management was a goal were 4.32 times more likely (95% confidence interval 2.26, 8.66) to report pain reduction of ≥2 units than patients receiving an MT session in which pain management was not a session goal.

Conclusion: This retrospective study supports the clinical effectiveness of MT for symptom management in community hospitals. However, additional research is needed to determine which characteristics of MT interventions and patients influence pain change.

Introduction: Topical application of capsaicin can produce an ongoing pain state in healthy participants. However, approximately one-third report no pain response (ie, nonresponders), and the reasons for this are poorly understood.

Objectives: In this study, we investigated temporal summation of pain (TSP) profiles, pain ratings and secondary hyperalgesia responses in responders and nonresponders to 1% topical capsaicin cream.

Methods: Assessments were made at baseline and then during an early (ie, 15 minutes) and late (ie, 45 minutes) time points post-capsaicin in 37 healthy participants.

Results: Participants reporting a visual analogue scale (VAS) rating of >50 were defined as responders (n = 24) and those with <50 VAS rating were defined as nonresponders (n = 13). There was a facilitation of TSP during the transition from an early to the late time point post-capsaicin (P<0.001) and the development of secondary hyperalgesia (P<0.05) in the responder group. Nonresponders showed no changes in TSP or secondary hyperalgesia during the early and late time points. There was an association between baseline TSP scores and the later development of a responder or nonresponder phenotype (r = 0.36; P = 0.03). Receiver operating characteristic analysis revealed that baseline TSP works as a good response predictor at an individual level (area under the curve = 0.75).

Conclusion: These data suggest that responders and nonresponders have different facilitatory pain mechanisms. The assessment of TSP may help to identify participants with stronger endogenous pain facilitation who may be more likely to respond to topical capsaicin.

The use of routinely collected health data (real-world data, RWD) to generate real-world evidence (RWE) for research purposes is a growing field. Computerized search methods, large electronic databases, and the development of novel statistical methods allow for valid analysis of data outside its primary clinical purpose. Here, we systematically reviewed the methodology used for RWE studies in pain research. We searched 3 databases (PubMed, EMBASE, and Web of Science) for studies using retrospective data sources comparing multiple groups or treatments. The protocol was registered under the DOI:10.17605/OSF.IO/KGVRM. A total of 65 studies were included. Of those, only 4 compared pharmacological interventions, whereas 49 investigated differences in surgical procedures, with the remaining studying alternative or psychological interventions or epidemiological factors. Most 39 studies reported significant results in their primary comparison, and an additional 12 reported comparable effectiveness. Fifty-eight studies used propensity scores to account for group differences, 38 of them using 1:1 case:control matching. Only 17 of 65 studies provided sensitivity analyses to show robustness of their findings, and only 4 studies provided links to publicly accessible protocols. RWE is a relevant construct that can provide evidence complementary to randomized controlled trials (RCTs), especially in scenarios where RCTs are difficult to conduct. The high proportion of studies reporting significant differences between groups or comparable effectiveness could imply a relevant degree of publication bias. RWD provides a potentially important resource to expand high-quality evidence beyond clinical trials, but rigorous quality standards need to be set to maximize the validity of RWE studies.

Introduction: Treatment of pain in preterm, sick, and healthy newborns and infants and toddlers (up to 2 years of age) is consistently reported to be inadequate, and effective strategies are poorly implemented.

Objectives: To present existing evidence of effective pain treatment strategies during needle-related procedures and to highlight initiatives focused on translating evidence into practice.

Methods: This Clinical Update focuses on the 2022 International Association for the Study of Pain Global Year for Translating Pain Knowledge to Practice in the specific population of newborns, infants, and toddlers. Best evidence is reviewed, and existing knowledge translation strategies and programs available to implement evidence into practice are presented.

Results: Effective strategies for newborn and young infants during frequently occurring needle procedures include small volumes of sweet solutions, breastfeeding, or skin-to-skin care when feasible and culturally acceptable. In addition, strategies such as nonnutritive sucking, positioning, swaddling, gentle touch, facilitated tucking, and secure holding can be used. For toddlers, the evidence is less robust, and discerning between pain and distress is challenging. However, strategies recommended for needle-related procedures include upright secure comfort holding by parents/caregivers, age-appropriate distraction, and topical anesthetics. Translation of effective pain management needs to involve the family, who need to be supported and empowered to comfort their child during painful procedures. Organizational, nationwide, and global initiatives aimed at improving implementation of effective pain treatments exist.

Conclusion: There is evidence of effective pain management strategies for newborns, infants, and toddlers, and a great deal of effort is being made to translate knowledge into action.

Introduction: Experiencing stress can contribute to unfavorable pain experiences, but outcomes vary across individuals. Evidence suggests that a person's specific reactivity to stressful events may influence pain responses. Previous studies measuring physiological stress reactivity have found associations with pain both clinically and in the laboratory. However, the time and cost required for testing physiological stress reactivity may limit clinical application.

Objective: Self-reported perception of one's own stress reactivity has been shown to correlate with physiological stress reactivity in relation to health outcomes and may represent a valuable tool in clinical pain assessment.

Methods: Using data from the Midlife in the US survey, we selected participants who did not have chronic pain at baseline (n = 1512) and who had data at follow-up 9 years later. Stress reactivity was assessed using a subscale of the Multidimensional Personality Questionnaire. We conducted a binary logistic regression to determine the odds of developing chronic pain, controlling for demographics and other health-related variables.

Results: Results indicate that higher reported stress reactivity at baseline increased the odds of developing chronic pain at follow-up (odds ratio (OR) = 1.085, 95% confidence interval (CI) (1.021, 1.153), P = 0.008), with the only other significant predictor being the number of chronic conditions (OR = 1.118, 95% CI (1.045, 1.197), P = 0.001).

Conclusion: Findings provide evidence for the predictive criterion validity of self-reported stress reactivity in the context of chronic pain risk. More generally, with increased need for virtual assessment and care, self-reported stress reactivity may be a useful, time-efficient, and cost-efficient tool for predicting pain outcomes in research and clinical contexts.

Introduction: Opioid-induced hyperalgesia (OIH) is a paradoxical phenomenon in which exposure to opioids can increase sensitivity to painful stimuli. Currently, several drugs have been used in an attempt to prevent OIH. We design this study to address the effect of preemptive treatment with ketamine, lidocaine, and ascorbic acid in a rat preclinical model of perioperative opioid-induced hyperalgesia.

Methods: To reproduce OIH in a model of postoperative pain, rats received successive doses of fentanyl subcutaneously and underwent an incision in the paw. In an attempt to prevent OIH, ketamine, lidocaine, and ascorbic acid were administered before treatment with fentanyl. The von Frey test and the hot-plate test were used to evaluate mechanical allodynia and thermal hyperalgesia, respectively, with a follow-up period from 1 hour up to 7 days after surgery. Spinal cord nerve terminals (synaptosomes) were used to assess glutamate release under our experimental conditions.

Results: Consecutive fentanyl injections increased the postoperative pain as indicated by increased thermal hyperalgesia and allodynia 48 hours after incision. Ketamine, lidocaine, and the combination of ketamine + lidocaine were able to prevent thermal hyperalgesia but not mechanical allodynia. Ascorbic acid did not prevent the hyperalgesia induced by fentanyl. We found no correlation between spinal glutamate release and the pharmacological treatments.

Conclusion: Fentanyl induced a hyperalgesic effect that last few days in a postoperative model of pain. Hyperalgesic effect was not totally inhibited by ketamine and lidocaine in rats. Increased glutamate release was not the main molecular mechanism of fentanyl-induced hyperalgesia.

Introduction: Digital therapeutics (DT) emerged and has been expanding rapidly for pain management. However, the efficacy of such approaches demonstrates substantial heterogeneity. Machine learning (ML) approaches provide a great opportunity for personalizing the efficacy of DT. However, the ML model accuracy is mainly associated with reduced clinical interpretability. Moreover, classical ML models are not adapted for the longitudinal nature of the DT follow-up data, which may also include nonlinear fluctuations.

Objectives: This study presents an analytical framework for personalized pain management using piecewise mixed-effects model trees, considering the data dependencies, nonlinear trajectories, and boosting model interpretability.

Methods: We demonstrated the implementation of the model with posture biofeedback training data of 3610 users collected during 8 weeks. The users reported their pain levels and posture quality. We developed personalized models for nonlinear time-related fluctuations of pain levels, posture quality, and weekly training duration using age, gender, and body mass index as potential moderating factors.

Results: Pain levels and posture quality demonstrated strong improvement during the first 3 weeks of the training, followed by a sustained pattern. The age of the users moderated the time fluctuations in pain levels, whereas age and gender interactively moderated the trajectories in the posture quality. Train duration increased during the first 3 weeks only for older users, whereas all the users decreased the training duration during the next 5 weeks.

Conclusions: This analytical framework offers an opportunity for investigating the personalized efficacy of digital therapeutics for pain management, taking into account users' characteristics and boosting interpretability and can benefit from including more users' characteristics.