Pain
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of neublastin in painful lumbosacral radiculopathy: a randomized, double-blinded, placebo-controlled phase 2 trial using Bayesian adaptive design (the SPRINT trial).
Neublastin (BG00010) is a first-in-class, glial cell-derived neurotrophic factor shown in preclinical studies and an early clinical trial to have potential for the treatment of neuropathic pain. SPRINT was a phase 2, multicenter, double-blinded, placebo-controlled study to evaluate efficacy/safety of 5 neublastin doses (50, 150, 400, 800, and 1200 μg/kg) administered as an intravenous injection 3 times/week for 1 week in patients with chronic painful lumbosacral radiculopathy, utilizing Bayesian response-adaptive study design. Primary endpoint was change from baseline in mean 24-hour average general pain intensity over a 5-day period (week 1) after the last dose, analyzed using a Bayesian normal dynamic linear model. ⋯ The most common adverse event in all neublastin dose groups was pruritus (79% vs 10% with placebo). There was no dose-response relationship with respect to primary/secondary efficacy outcomes or incidence of pruritus, despite dose-proportional increases in serum neublastin concentrations. In conclusion, while this study showed some evidence of pain relief with neublastin, particularly at the lowest dose, there was no clear dose-response relationship for pain reduction or the most common adverse event of pruritus.
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Observational Study
Sequential analysis of child pain behaviors and maternal responses: an observational study.
This laboratory-based study examined lagged associations between child pain behavior and maternal responses as a function of maternal catastrophizing (CAT). Mothers completed the parent version of the Pain Catastrophizing Scale. Children participated in a validated water ingestion procedure to induce abdominal discomfort with mothers present. ⋯ Mothers higher in CAT responded solicitously at T + 1 irrespective of their child's preceding pain behavior, and their children exhibited pain behavior at T + 1 irrespective of the mother's preceding solicitousness. Mothers lower in CAT were more likely to respond solicitously at T + 1 after child pain behavior, and their children were more likely to exhibit pain behavior at T + 1 after maternal solicitousness. These findings indicate that high CAT mothers and their children exhibit inflexible patterns of maternal solicitousness and child pain behavior, and that such families may benefit from interventions to decrease CAT and develop more adaptive responses.
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Despite the frequency of pain among children, little is known about its effects on learning and school outcomes. The objective of this study was to quantify the association of pain and academic achievement while taking into account the presence of co-occurring emotional symptoms. A population-based stratified random sample of 1239 students aged 8 to 9 years from primary schools in Melbourne, Australia, was recruited for the Childhood to Adolescence Transition Study. ⋯ Children with chronic pain were a year behind their peers in both reading and numeracy. Among primary school students, pain was associated with lower reading scores even after adjusting for the presence of emotional symptoms. Although population-based longitudinal studies will be required to ascertain consistency and possible causality, grounds exist for considering pain and emotional symptoms in the assessment of children with reading difficulties.
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Randomized Controlled Trial
The relationship of sociodemographic and psychological variables to chronic pain variables in a low-income population.
Chronic pain is a pervasive condition that is complicated by economic, educational, and racial disparities. This study analyzes key factors associated with chronic pain within an understudied and underserved population. The sample is characterized by a triple disparity with respect to income, education/literacy, and racial barriers that substantially increase the vulnerability to the negative consequences of chronic pain. ⋯ Depressive symptoms and pain catastrophizing mediated the relationships between age and pain variables, whereas pain catastrophizing mediated the effects of primary literacy and poverty status. Some reversed models were equivalent to the hypothesized models, suggesting the possibility of bidirectionality. Although cross-sectional findings cannot establish causality, our results highlight the critical role psychological factors play in individuals with chronic pain and multiple health disparities.