Articles: pain.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study.
Objective: To investigate the efficacy and safety of mirogabalin, an α2δ ligand, in patients with fibromyalgia (FM). Methods: In three 13-week, multicenter, double-blind, phase 3 studies (studies A, B, and C), patients with FM (n = 1293, 1270, and 1301, respectively) were randomized (1:1:1:1) to placebo, pregabalin 150 mg twice daily, mirogabalin 15 mg once daily or mirogabalin 15 mg twice daily. The primary endpoint was the change in weekly average daily worst pain score (ADPS) at week 13. ⋯ Mirogabalin was well tolerated by most patients in the phase 3 studies; no unexpected adverse events occurring during the 52-week extension study. Conclusion: While both mirogabalin doses were well tolerated by most patients and showed potential for reducing pain associated with FM, the primary endpoint of significant pain reduction in patients on mirogabalin compared with placebo was not achieved in any of the three randomized controlled studies. Clinical trial registration: NCT02146430; NCT02187159; NCT02187471; and NCT02234583 (extension study).
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Journal of critical care · Oct 2019
Multicenter StudyCurrent practice and perceptions regarding pain, agitation and delirium management in patients receiving venovenous extracorporeal membrane oxygenation.
To characterize monitoring of pain, agitation, and delirium; investigate opioid and sedative choices; and describe prevention and treatment of delirium in adults receiving venovenous extracorporeal membrane oxygenation (vv-ECMO) for respiratory failure. ⋯ Most respondents use validated scales and protocols to assess and manage pain, agitation/sedation, and delirium. The majority of respondents reported targeting a deep level of sedation with propofol being used for both deep and light levels of sedation.
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Acta Anaesthesiol Scand · Sep 2019
Multicenter StudyGenetic polymorphisms and prediction of chronic post-surgical pain after hysterectomy-a subgroup analysis of a multicenter cohort study.
Chronic post-surgical pain (CPSP) is a serious problem. Clinical and psychological variables have not been able to explain all observed variance in prevalence and severity of CPSP. The first objective is to determine the association between genetic polymorphisms and the prevalence of CPSP after hysterectomy. The second objective is to analyze if the implementation of genetic polymorphisms into a previously performed clinical and psychological predictor analysis on the development of CPSP after hysterectomy will improve its discriminatory power. ⋯ The rs4818 polymorphism within the COMT gene was associated with the prevalence of CPSP 3 months after hysterectomy, but the implementation of rs4818 into the prediction model did not significantly improve the chance of identifying hysterectomy patients at risk for CPSP.
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Experimental gerontology · Sep 2019
Multicenter Study Observational StudyMovement-evoked pain, physical function, and perceived stress: An observational study of ethnic/racial differences in aging non-Hispanic Blacks and non-Hispanic Whites with knee osteoarthritis.
Knee osteoarthritis (OA) is a pervasive musculoskeletal condition, often exacerbated by movement-evoked pain (MEP). Despite established research demonstrating significant racial differences in OA pain, few studies have investigated ethnic/racial group differences in MEP and lower extremity function and their association with psychosocial factors, such as perceived stress. Therefore, the primary aims were: (1) to identify ethnic/racial group differences in persons with or at risk for knee OA pain based on MEP, physical performance, and perceived stress measures, and (2) to determine if perceived stress explains the relationship between MEP and function in non-Hispanic Blacks (NHBs) and non-Hispanic Whites (NHWs). ⋯ Our cross-sectional study demonstrated important ethnic/racial differences in MEP and function. Also, perceived stress had a stronger effect on MEP in NHBs, suggesting that perceived stress may more strongly influence pain with physical movement among NHB adults. MEP may be a clinically important pain outcome to measure in persons with OA, and these data warrant future research on the impact of stress on pain and functional outcomes in older adults, particularly in NHBs.
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J Diabetes Investig · Sep 2019
Randomized Controlled Trial Multicenter StudyMirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients.
This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α2 δ subunit of voltage-dependent Ca2+ channels, for the treatment of diabetic peripheral neuropathic pain (DPNP). ⋯ Mirogabalin relieved DPNP in a dose-dependent manner; mirogabalin 30 mg/day showed statistically significant pain relief (vs placebo) in Asian DPNP patients. All doses of mirogabalin tested were well tolerated.