The purpose of this meta-analysis of randomized controlled trials was to evaluate the efficacy of psychological interventions for adults with noncancerous chronic low back pain (CLBP). The authors updated and expanded upon prior meta-analyses by using broad definitions of CLBP and psychological intervention, a broad data search strategy, and state-of-the-art data analysis techniques. All relevant controlled clinical trials meeting the inclusion criteria were identified primarily through a computer-aided literature search. Two independent reviewers screened abstracts and articles for inclusion criteria and extracted relevant data. Cohen's d effect sizes were calculated by using a random effects model. Outcomes included pain intensity, emotional functioning, physical functioning (pain interference or pain-specific disability, health-related quality of life), participant ratings of global improvement, health care utilization, health care provider visits, pain medications, and employment/disability compensation status. A total of 205 effect sizes from 22 studies were pooled in 34 analyses. Positive effects of psychological interventions, contrasted with various control groups, were noted for pain intensity, pain-related interference, health-related quality of life, and depression. Cognitive-behavioral and self-regulatory treatments were specifically found to be efficacious. Multidisciplinary approaches that included a psychological component, when compared with active control conditions, were also noted to have positive short-term effects on pain interference and positive long-term effects on return to work. The results demonstrated positive effects of psychological interventions for CLBP. The rigor of the methods used, as well as the results that reflect mild to moderate heterogeneity and minimal publication bias, suggest confidence in the conclusions of this review.
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. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. 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.
The strong correlation between LLZO grain size and the Li–LLZO stability as a function of Li plating rate is demonstrated. The increase in grain size reduces the grain boundary area and hence the number of possible failure points leading to an increased maximum tolerable current density.
A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.
This manuscript describes the development and initial validation of a self-report questionnaire designed to assess an individual's readiness to adopt a self-management approach to their chronic pain condition. Theory and preliminary empirical work informed the development of a pool of items that were administered to a sample of individuals reporting chronic pain. Analyses of the data support a four factor measure that is consistent with the transtheoretical model of change and associated stages of change model. Each of the four factors, precontemplation, contemplation, action, and maintenance, was found to be internally consistent and stable over time. There was also substantial support for each factor's discriminant and criterion-related validity.
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