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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
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. Me...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506009/ https://www.ncbi.nlm.nih.gov/pubmed/31118759 http://dx.doi.org/10.2147/JPR.S191906 |
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author | Taguchi, Toshihiko Nozawa, Kazutaka Parsons, Bruce Yoshiyama, Tamotsu Ebata, Nozomi Igarashi, Ataru Fujii, Koichi |
author_facet | Taguchi, Toshihiko Nozawa, Kazutaka Parsons, Bruce Yoshiyama, Tamotsu Ebata, Nozomi Igarashi, Ataru Fujii, Koichi |
author_sort | Taguchi, Toshihiko |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6506009 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-65060092019-05-22 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 Taguchi, Toshihiko Nozawa, Kazutaka Parsons, Bruce Yoshiyama, Tamotsu Ebata, Nozomi Igarashi, Ataru Fujii, Koichi J Pain Res Original Research 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. Dove 2019-05-03 /pmc/articles/PMC6506009/ /pubmed/31118759 http://dx.doi.org/10.2147/JPR.S191906 Text en © 2019 Taguchi et al. http://creativecommons.org/licenses/by-nc/3.0/ 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). |
spellingShingle | Original Research Taguchi, Toshihiko Nozawa, Kazutaka Parsons, Bruce Yoshiyama, Tamotsu Ebata, Nozomi Igarashi, Ataru Fujii, Koichi 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506009/ https://www.ncbi.nlm.nih.gov/pubmed/31118759 http://dx.doi.org/10.2147/JPR.S191906 |
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