Pain
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A systematic review and subset meta-analysis of published randomised controlled trials of psychological therapies for children and adolescents with chronic pain is reported. A search of four computerised abstracting services recovered 123 papers from which 28 potential trials were identified. Eighteen met the criteria for inclusion in the review. ⋯ Meta-analysis was applicable for 12 headache trials and one trial of recurrent abdominal pain using the Pain Index. The odds-ratio for a 50% reduction in pain was 9.62 and the number needed to treat was 2.32, indicating that the psychological treatments examined are effective in reducing the pain of headache. The quality of the 18 trials retrieved is narratively reviewed and suggestions for the development of trials in this field are made.
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Randomized Controlled Trial Comparative Study Clinical Trial
Postsurgical pain outcome assessment.
Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments. Perhaps the most important aspect of a pain measure's validity is its sensitivity, or ability to detect changes in pain over time and due to treatment. Several factors may affect a measure's sensitivity, including the complexity of the rating task for the measure, the number of pain intensity levels assessed by the measure, the dimension of pain assessed (e.g. pain intensity vs. pain relief), and the number of individual ratings (e.g. single rating vs. composite score) used to create the measure. ⋯ However, contrary to our prediction, a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects. Finally, we found that pain relief ratings were related to, but also distinct from, change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point. These findings have important implications for the assessment of pain in clinical trials.
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Clinical Trial Controlled Clinical Trial
Enhanced temporal summation of second pain and its central modulation in fibromyalgia patients.
We have previously shown that fibromyalgia (FMS) patients have enhanced temporal summation (windup) and prolonged decay of heat-induced second pain in comparison to control subjects, consistent with central sensitization. It has been hypothesized that sensory abnormalities of FMS patients are related to deficient pain modulatory mechanisms. Therefore, we conducted several analyses to further characterize enhanced windup in FMS patients and to determine whether it can be centrally modulated by placebo, naloxone, or fentanyl. ⋯ However, naloxone injection had the same magnitudes of effect on first or second pain as that produced by placebo injection. Hypoalgesic effects of saline placebo and fentanyl on windup were at least as large in FMS as compared to NC subjects and therefore do not support the hypothesis that pain modulatory mechanisms are deficient in FMS. To the extent that temporal summation of second pain (windup) contributes to processes underlying hyperalgesia and persistent pain states, these results indirectly suggest that these processes can be centrally modulated in FMS patients by endogenous and exogenous analgesic manipulations.
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The non-communicating children's pain checklist (NCCPC) has displayed preliminary validity and reliability for measuring pain in children with severe cognitive impairments (Dev Med Child Neurol 42 (2000) 609). This study provides evidence of the psychometric properties of a revised NCCPC (NCCPC-R) with a larger cohort of children. Caregivers of 71 children with severe cognitive impairments (aged 3-18) conducted observations of their children using the NCCPC-R during a time of pain and a time without pain. ⋯ Analyses of children's individual scores indicated up to 95% of their scores were consistent. Receiver operating characteristic curves suggest a score of 7 or greater on the NCCPC-R as indicative of pain in children with cognitive impairments, with 84% sensitivity and up to 77% specificity. These results provide evidence of NCCPC-R having excellent psychometric properties.
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Clinical Trial
Assessment of the reproducibility of intradermal administration of capsaicin as a model for inducing human pain.
The reproducibility and tolerability of intradermal (i.d.) administration of capsaicin as a method for eliciting human pain was assessed in healthy male volunteers (n = 12). The primary endpoints for assessing pain were spontaneous pain response and areas of allodynia, pinprick hyperalgesia and neurogenic inflammation. These were recorded before, immediately after, and at regular intervals following each of four doses (250 microg) of capsaicin (two per trial day). ⋯ A positive correlation was found between the area of allodynia and area of pinprick hyperalgesia (r(2) = 0.835). Overall, the model was well tolerated with no reports of adverse events. We conclude that the tolerability profile, and variability of i.d. capsaicin-induced pain is acceptable for pharmacological profiling of novel anti-nociceptive agents, with limited number of subjects.