Pain
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Randomized Controlled Trial
Effect of combined pharmacological, behavioral, and physical interventions for procedural pain on salivary cortisol and neurobehavioral development in preterm infants: a randomized controlled trial.
Repeated procedural pain may lead to increased secretion of cortisol and future neurobehavioral development disorders in preterm infants. Changes in the cortisol level may mediate the effect of neonatal repetitive procedural pain on altered childhood neurobehavioral development in preterm infants. However, few studies have investigated the effect of combined pharmacological, behavioral, and physical interventions over repeated painful procedures on pain response, cortisol level, and neurobehavioral development. ⋯ The Premature Infant Pain Profile scores in the early, middle, and late periods of the NICU stay were measured, as were the basal salivary cortisol level at admission and discharge, the Neonatal Behavioral Neurological Assessment score at 40 weeks' corrected gestational age, and the incidence of adverse effects during the study period. Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants. This effect may have been mediated through decreased cortisol levels and reduced repeated procedural pain.
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Randomized Controlled Trial Multicenter Study
Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial.
Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. ⋯ Spinal cord stimulation screening trial had a sensitivity of 100% (95% CI: 78-100) and specificity of 8% (95% CI: 1-25). The mean incremental cost-effectiveness ratio of TG vs NTG was £78,895 per additional quality-adjusted life-year gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening TG provides superior patient outcomes or is cost-effective compared to a no trial screening approach.
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Randomized Controlled Trial
Factors with impact on magnitude of the placebo response in randomized, controlled, cross-over trials in peripheral neuropathic pain.
The presence and magnitude of placebo responses is important for the outcome in clinical trials of analgesics. This explorative study aimed at identifying patients and trial-specific factors with impact on this response in randomized, controlled, cross-over trials in peripheral neuropathic pain. Data were derived from 7 trials and included observations on pinprick hyperalgesia, allodynia, and pain on repetitive stimulation. ⋯ The findings were similar in patients having placebo in the first treatment period. There was no marked difference between patients with (n = 43) and without (n = 275) a clinically meaningful placebo response with respect to the patient-specific factors including frequency of sensory signs and symptoms. In conclusion, this study on cross-over trials in peripheral neuropathic pain found no robust impact of trial and patient-specific factors on the placebo response.
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Randomized Controlled Trial
A digital health psychological intervention (WebMAP Mobile) for children and adolescents with chronic pain: results of a hybrid effectiveness-implementation stepped wedge cluster randomized trial.
Although psychological treatments benefit youth with chronic pain, treatment is not accessible in most communities. Digital health interventions offer promise for expanding access and reach to this population. Using a stepped-wedge cluster randomized trial design, we evaluated effectiveness and implementation of a digital health delivered psychological intervention for pediatric chronic pain. ⋯ Greater engagement (number of completed modules) was associated with significantly greater reductions in pain and disability from pre-treatment to follow-up (d's = -0.57 and -0.38, P < 0.05). Parents, youth, and providers found treatment acceptable; providers had positive attitudes and demonstrated referrals over a maintenance period. Further research is needed to understand how to enhance treatment engagement with digital health interventions and optimize implementation.
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Randomized Controlled Trial
Individuals with chronic pain have the same response to placebo analgesia as healthy controls in terms of magnitude and reproducibility.
It is unclear whether a diagnosis of chronic pain is associated with an increase or decrease in the placebo response. The aim of this study was to use an experimental placebo conditioning paradigm to test whether expectancy for pain relief impacts on acute pain perception in individuals with a chronic pain diagnosis of osteoarthritis (OA) or fibromyalgia (FM), compared to healthy individuals (HIs). An inert cream was applied to the dominant forearm of participants (60 OA, 79 FM, and 98 HI), randomly assigned to either a placebo or control group. ⋯ The results were similar in the repeat session. The results demonstrate that individuals with chronic pain respond to experimental placebo analgesia in a similar and reproducible manner as HIs, despite higher levels of psychological comorbidity. This has implications for using placebo analgesia in the treatment of chronic pain.