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      Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings

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          Abstract

          Background: Despite high prevalence of chronic neck pain in Japan and the negative impact pain has on patient’s quality of life (QoL), the therapeutic value of pregabalin for chronic neck pain with a neuropathic pain (NeP) component has not been assessed in a typical Japanese health care setting.

          Methods: An 8-week, non-interventional, multicenter, observational study of Japanese adults (≥20 years) with chronic refractory cervical pain including a NeP element (for ≥12 weeks) and sleep disturbance on the Pain-Related Sleep-Interference Scale (PRSIS) ≥1 (from 0 “does not interfere with sleep” to 10 “completely interferes”). Patients received either usual care with conventional analgesics or pregabalin (150–600 mg/day) for 8 weeks. “Usual care” with analgesics or other treatment(s) was determined based on physician’s best clinical judgment. Primary endpoint was change from baseline to week 8 in PRSIS. Secondary endpoints included: change from baseline to week 4 in PRSIS, and to week 4 and 8 in pain Numerical Rating Scale (NRS; from 0 “no pain” to 10 “worst possible pain”), and on the Neck Disability Index (NDI). Other assessments of QoL were undertaken. Safety was monitored.

          Results: Overall, 369 patients received pregabalin (n=145) or usual care (n=224). The median (range) dose of pregabalin was 49.6 (25.0–251.5) mg/day. Least-squares mean change in PRSIS from baseline to week 8 favored pregabalin (–1.167 vs –0.269; treatment difference –0.898 [95% CI –1.262, –0.535], P<0.001). Similar observations were seen at week 4 in favor of pregabalin versus usual care ( P<0.001). Pregabalin significantly improved pain NRS and NDI scores at weeks 4 and 8 (all P<0.001). Improvements in QoL versus usual care were also observed. Pregabalin was generally well tolerated.

          Conclusion: In this open-label study, pregabalin improved PRSIS and resulted in clinically meaningful reductions in pain in Japanese patients with NeP associated with chronic cervical pain.

          ClinicalTrials.gov identifier: NCT02868359.

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          Most cited references 31

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          The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.

          Best evidence synthesis. To undertake a best evidence synthesis of the published evidence on the burden and determinants of neck pain and its associated disorders in the general population. The evidence on burden and determinants of neck has not previously been summarized. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders performed a systematic search and critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Studies meeting criteria for scientific validity were included in a best evidence synthesis. We identified 469 studies on burden and determinants of neck pain, and judged 249 to be scientifically admissible; 101 articles related to the burden and determinants of neck pain in the general population. Incidence ranged from 0.055 per 1000 person years (disc herniation with radiculopathy) to 213 per 1000 persons (self-reported neck pain). Incidence of neck injuries during competitive sports ranged from 0.02 to 21 per 1000 exposures. The 12-month prevalence of pain typically ranged between 30% and 50%; the 12-month prevalence of activity-limiting pain was 1.7% to 11.5%. Neck pain was more prevalent among women and prevalence peaked in middle age. Risk factors for neck pain included genetics, poor psychological health, and exposure to tobacco. Disc degeneration was not identified as a risk factor. The use of sporting gear (helmets, face shields) to prevent other types of injury was not associated with increased neck injuries in bicycling, hockey, or skiing. Neck pain is common. Nonmodifiable risk factors for neck pain included age, gender, and genetics. Modifiable factors included smoking, exposure to tobacco, and psychological health. Disc degeneration was not identified as a risk factor. Future research should concentrate on longitudinal designs exploring preventive strategies and modifiable risk factors for neck pain.
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            The burden and determinants of neck pain in whiplash-associated disorders after traffic collisions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.

            Best evidence synthesis. To undertake a best evidence synthesis on the burden and determinants of whiplash-associated disorders (WAD) after traffic collisions. Previous best evidence synthesis on WAD has noted a lack of evidence regarding incidence of and risk factors for WAD. Therefore there was a warrant of a reanalyze of this body of research. A systematic search of Medline was conducted. The reviewers looked for studies on neck pain and its associated disorders published 1980-2006. Each relevant study was independently and critically reviewed by rotating pairs of reviewers. Data from studies judged to have acceptable internal validity (scientifically admissible) were abstracted into evidence tables, and provide the body of the best evidence synthesis. The authors found 32 scientifically admissible studies related to the burden and determinants of WAD. In the Western world, visits to emergency rooms due to WAD have increased over the past 30 years. The annual cumulative incidence of WAD differed substantially between countries. They found that occupant seat position and collision impact direction were associated with WAD in one study. Eliminating insurance payments for pain and suffering were associated with a lower incidence of WAD injury claims in one study. Younger ages and being a female were both associated with filing claims or seeking care for WAD, although the evidence is not consistent. Preliminary evidence suggested that headrests/car seats, aimed to limiting head extension during rear-end collisions had a preventive effect on reporting WAD, especially in females. WAD after traffic collisions affects many people. Despite many years of research, the evidence regarding risk factors for WAD is sparse but seems to include personal, societal, and environmental factors. More research including, well-defined studies with accurate denominators for calculating risk, and better consideration of confounding factors, are needed.
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              Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial.

               J Satoh,  S Yagihashi,  M Baba (2011)
              To evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                JPR
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                03 May 2019
                2019
                : 12
                : 1411-1424
                Affiliations
                [1 ]Japan Organization of Occupational Health and Safety, Yamaguchi Rosai Hospital , Sanyo-Onoda, Yamaguchi, Japan
                [2 ]Medical Affairs, Pfizer Japan Inc , Tokyo, Japan
                [3 ]Global Medical Product Evaluation, Pfizer Inc , New York, NY, USA
                [4 ]Biometrics and Data Management, Development Japan, Pfizer R&D Japan G.K. , Tokyo, Japan
                [5 ]Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo , Tokyo, Japan
                Author notes
                Correspondence: Bruce ParsonsPfizer Inc , 235 East 42nd Street 235/4/84, New York, NY10017, USATel +1 212 573 1649Email bruce.parsons@ 123456pfizer.com
                Article
                191906
                10.2147/JPR.S191906
                6506009
                © 2019 Taguchi et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 4, Tables: 3, References: 46, Pages: 14
                Categories
                Original Research

                Anesthesiology & Pain management

                sleep, pregabalin, japan, neuropathic pain, neck pain

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