The journal of pain : official journal of the American Pain Society
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Thorough assessment and reporting of adverse events (AEs) facilitates a detailed understanding of a treatment's risk-benefit profile. Although the Consolidated Standards of Reporting Trials (CONSORT) 2004 statement provides recommendations regarding AE reporting, adherence to these standards is often inadequate. We investigated AE reporting in clinical trials of intravenous and invasive pain treatments published in 6 major anesthesiology and pain journals between 2000 to 2003 and 2006 to 2012. ⋯ Anesthesiology and pain journals were similar in AE reporting quality, although industry-sponsored trials reported more AE information than nonindustry sponsored trials. Improvement is needed in AE reporting in analgesic clinical trials. The CONSORT checklist and ACTTION AE recommendations can assist investigators and editors in improving clinical trial transparency and quality.
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Randomized Controlled Trial
Involvement of opioid receptors and α2-adrenoceptors in inhibitory pain modulation processes: a double-blind placebo-controlled crossover study.
In healthy humans, high-frequency electrical stimulation (HFS) of the forearm not only evokes local signs of central sensitization but also triggers broader ipsilateral inhibitory influences on pain akin to a lateralized form of conditioned pain modulation. Paradoxically, some of these inhibitory influences are augmented by α2-adrenoceptor blockade. To determine whether opioid peptides mediate inhibitory effects after HFS, the opioid receptor antagonist naltrexone was coadministered orally with the α2-adrenoceptor antagonist yohimbine in 16 healthy women in a double-blind placebo-controlled crossover study. ⋯ Unlike yohimbine alone, the naltrexone with yohimbine combination blocked analgesia evoked by HFS in the ipsilateral forehead to blunt pressure, and opposed the ipsilateral inhibitory effect of pain in the temple on electrically-evoked pain at the HFS-treated site in the forearm. These findings imply involvement of opioid peptides in an ipsilateral analgesic response that complements the more generalized form of conditioned pain modulation. Opioid mediation of this ipsilateral analgesic response appears to override opposing α2-adrenoceptor effects.
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Randomized Controlled Trial
Exploring what factors mediate treatment effect: Example of the STarT Back study high-risk intervention.
Interventions developed to improve disability outcomes for low back pain (LBP) often show only small effects. Mediation analysis was used to investigate what led to the effectiveness of the STarT Back trial, a large primary care-based trial that treated patients consulting with LBP according to their risk of a poor outcome. The high-risk subgroup, randomized to receive either psychologically-informed physiotherapy (n = 93) or current best care (n = 45), was investigated to explore pain-related distress and pain intensity as potential mediators of the relationship between treatment allocation and change in disability. ⋯ Outcome was measured using the Roland-Morris Disability Questionnaire. Change in pain-related distress and pain intensity were found to have a significant mediating effect of .25 (standardized estimate, bootstrapped 95% confidence interval, .09-.39) on the relationship between treatment group allocation and change in disability outcome. This study adds to the evidence base of treatment mediation studies in pain research and the role of distress in influencing disability outcome in those with complex LBP.
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Barriers to clinical trial recruitment can delay study completion, potentially resulting in increased costs and an unrepresentative sample. In the current study of 150 participants with chronic pain, we used a computerized adaptive choice-based conjoint survey that included 8 characteristics that may affect enrollment in pharmacologic pain treatment trials (ie, treatment allocation, frequency of pain ratings, treatment administration method, current medications, number of study visits, availability of evening and weekend visits, invasiveness of laboratory procedures, payment). ⋯ The fourth most important characteristic was number of study visits (13%), with participants preferring fewer in-person visits and more phone contacts. Understanding the preferences of potential participants is an important step toward enhancing enrollment in pain treatment trials.
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Chronic pain is prevalent in children/adolescents and contributes to high rates of healthcare utilization. Research suggests injustice perceptions about pain are important in adult patients and a possible treatment focus. We conducted a preliminary evaluation of the psychometric properties of the Injustice Experiences Questionnaire (IEQ) and the relationship between injustice perceptions, pain, and functioning in chronic pain patients (N = 139, mean age = 15 years, 72% female) presenting to a pediatric pain clinic. ⋯ Additionally, perceived injustice remained significantly associated with pain intensity, functional disability, emotional functioning, social functioning, and school functioning after accounting for relevant demographic and clinical factors. This is the first study to suggest that injustice perceptions are important in the experience of pediatric chronic pain patients. Future studies should more thoroughly examine the psychometric properties of the IEQ in children/adolescents and elucidate the causal nature of these relationships, which will inform treatment efforts to improve pediatric pain care.