Pain
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Trial methodology was evaluated in paediatric analgesic studies. Databases were searched for randomised, placebo controlled studies of systemic paracetamol, NSAIDs and opioids administered for acute postoperative pain in children. Eighty-three studies met the inclusion criteria and 40 were included for the analysis. ⋯ Most patients in the placebo groups had pain that was greater than 30% of the maximum. In conclusion, analysis of the methodology showed several aspects of trial design that can be improved in future studies. Placebo control groups can be used in paediatric analgesic studies to demonstrate internal sensitivity.
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Randomized Controlled Trial Comparative Study Clinical Trial
Duloxetine vs. placebo in patients with painful diabetic neuropathy.
The aim of this study was to examine the efficacy and safety of duloxetine, a balanced and potent dual reuptake inhibitor of serotonin and norepinephrine, in the management of diabetic peripheral neuropathic pain. Serotonin and norepinephrine are thought to inhibit pain via descending pain pathways. In a 12-week, multicenter, double-blind study, 457 patients experiencing pain due to polyneuropathy caused by Type 1 or Type 2 diabetes mellitus were randomly assigned to treatment with duloxetine 20 mg/d (20 mg QD), 60 mg/d (60 mg QD), 120 mg/d (60 mg BID), or placebo. ⋯ Significantly more patients in all three active-treatment groups achieved a 50% reduction in the 24-h Average Pain Score compared with placebo. Duloxetine treatment was considered to be safe and well tolerated with less than 20 percent discontinuation due to adverse events. Duloxetine at 60 and 120 mg/d was safe and effective in the management of diabetic peripheral neuropathic pain.
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Randomized Controlled Trial Comparative Study Clinical Trial
Effects of a workplace physical exercise intervention on the intensity of headache and neck and shoulder symptoms and upper extremity muscular strength of office workers: a cluster randomized controlled cross-over trial.
The purpose of the study was to examine the effects of a workplace physical exercise intervention on the perceived intensity of headache and the intensity of symptoms in the neck and shoulders, as well as on the extension and flexion strength of the upper extremities. The study was a cluster randomized controlled trial. The cross-over design consisted of physical exercise intervention (15 weeks) and no-intervention (15 weeks). ⋯ The mean increase in the extension strength of the upper extremities was 1.3 kg (95% CI 0.5-2.1) (P=0.001) or 4% (95% CI 1-6). The intervention had no effect on the intensity of shoulder symptoms or the flexion strength of the upper extremities. Specific exercise may be clinically important to alleviate headache and neck symptoms.
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Comparative Study
The Val158Met polymorphism of the human catechol-O-methyltransferase (COMT) gene may influence morphine requirements in cancer pain patients.
Catechol-O-methyltransferase (COMT) inactivates dopamine, epinephrine and norepinephrine in the nervous system. A common functional polymorphism (Val158Met) leads to a three- to-four-fold variation in the COMT enzyme activity, the Met form displaying lower enzymatic activity. The Val158Met polymorphism affects pain perception, and subjects with the Met/Met genotype have the most pronounced response to experimental pain. ⋯ Patients with the Val/Val genotype (n=44) needed more morphine (155+/-160 mg/24 h) when compared to the Val/Met (117+/-100 mg/24 h; n=96) and the Met/Met genotype (95+/-99 mg/24 h; n=67) groups (P=0.025). This difference was not explained by other factors such as duration of morphine treatment, performance status, time since diagnosis, perceived pain intensity, adverse symptoms, or time until death. These results suggest that genetic variation in the COMT gene may contribute to variability in the efficacy of morphine in cancer pain treatment.
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Comparative Study
Qualitative and quantitative characterization of the thermal grill.
Concurrent applications to the skin of spatially adjacent bands of innocuous warm and cool stimuli would elicit a peculiar sensation, known as the 'thermal grill illusion'. To validate the thermal grill as a research tool, this two-phase study qualitatively characterizes this peculiar sensation and further quantitatively establishes the temperature matching of the most intense/noxious thermal grill stimulations at two different time points. The temperature combinations (degrees C) tested were: 18/18, 42/42, 18/42, 20/20, 40/40, 20/40, 22/22, 38/38, 22/38, 24/24, 36/36 and 24/36. ⋯ At the 3-second time point, the matching temperatures (+/-SD) of 20/40 and 18/42 were 45.7+/-1.8 (range 44-48) and 46.6+/-1.5 (range 44-48) degrees C, respectively, whereas the matching temperatures for the single temperature combinations were similar to the set temperatures. Importantly, at the 10-second time point, none of the combinations were significantly greater than the highest of the pair of stimuli. The time course variation in the perception of the combined stimuli suggests an adaptation occurred in central processing.