Pain
-
There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. ⋯ We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.
-
Randomized Controlled Trial
Fibromyalgia: Moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain.
Chronic pain is associated with a range of other problems, including disturbed sleep, depression, anxiety, fatigue, reduced quality of life, and an inability to work or socialise. We investigated whether good symptom control of pain (using definitions of moderate and substantial benefit) is associated with improvement in other symptoms. Individual patient data from four randomised trials in fibromyalgia (2575 patients) lasting 8-14weeks were used to calculate percentage pain reduction for each completing patient (1858), divided into one of five groups according to pain reduction, irrespective of treatment: substantial benefit - 50% pain reduction; moderate - 30% to <50%; minimal - 15% to <30%; marginal - 0% to <15%; worse - <0% (increased pain intensity). ⋯ Substantial pain intensity reduction resulted in 0.11 QALYs gained, and moderate pain intensity reduction in 0.07 QALYs gained over a 12-month period. Substantial and moderate pain intensity reduction predicts broad beneficial outcomes and improved quality of life that do not occur without pain relief. Pain intensity reduction is a simple and effective predictor of which patients should continue treatment, and which should discontinue and try an alternative therapy.
-
Due to the cross-sectional nature of previous studies, whether mechanical factors predict the onset of Chronic oro-facial pain remains unclear. Aims of the current study were to test the hypotheses that self-reported mechanical factors would predict onset of Chronic oro-facial pain and that any observed relationship would be independent of the confounding effects of psychosocial factors and reporting of other unexplained symptoms. About 1735 subjects who had completed a baseline questionnaire were assessed at 2year follow-up for the presence of Chronic oro-facial pain, psychosocial factors (anxiety and depression, illness behaviour, life stressors and reporting of somatic symptoms), mechanical dysfunction (facial trauma, grinding, phantom bite and missing teeth) and reporting of other unexplained symptoms (chronic widespread pain, irritable bowel syndrome and chronic fatigue). ⋯ I. 2.2-7.4) and age (RR 0.2, 95% CI 0.1-0.7). The findings from this prospective study support the hypothesis that psychosocial factors are markers for onset of Chronic oro-facial pain. The efficacy of early psychological management of Chronic oro-facial pain to address these factors should be a priority for future investigations.
-
Although the verbal numeric scale (VNS) is used frequently at patients' bedsides, it has never been formally validated in children with acute pain. In order to validate this scale, a prospective cohort study was performed in children between 8 and 17years presenting to a pediatric emergency department (ED) with acute pain. Pain was graded using the VNS, the visual analogue scale (VAS), and the verbal rating scale (VRS). ⋯ The VNS minimal clinically significant difference was 1. The VNS had good test-retest reliability with 95% limits of agreement of -0.9 and 1.2. In conclusion, the VNS provides a valid and reliable scale to evaluate acute pain in children aged 8-17years but is not interchangeable with the VAS.
-
The value of chronic opioid therapy (COT) for chronic non-cancer pain (CNCP) patients is determined by a balance of poorly understood benefits and harms. Traditionally, this balance has been framed as the potential for improved pain control versus risks of iatrogenic addiction, drug diversion, and aberrant drug-related behaviors. These potential harms are typically defined from the providers' perspective. ⋯ High levels of opioid-related problems and concerns were not explained by differences in pain intensity or persistence. Patients with medium to high PODS scores were often concerned about their ability to control their use of opioid medications, but prior substance abuse diagnoses and receiving excess days supply of opioids were much less common in these patients than depression and pain-related interference with activities. These results suggest two types of potential harm from COT attributed by CNCP patients to opioids: psychosocial problems that are distinct from poor pain control and opioid control concerns that are distinct from opioid misuse or addiction.