{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T11:51:17Z","timestamp":1772711477078,"version":"3.50.1"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2015,6,8]],"date-time":"2015-06-08T00:00:00Z","timestamp":1433721600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006506","name":"Depomed","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006506","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pain Practice"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>We assessed the efficacy and safety of extended\u2010release gabapentin in a 15\u2010week, open\u2010label, single\u2010arm, single\u2010center study in patients with fibromyalgia (<jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Subjects with documented diagnosis of <jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content> were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their <jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content> pain, were excluded from the study. Subjects were given an extended\u2010release gabapentin starter pack and treated for total of 12\u00a0weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (<jats:styled-content style=\"fixed-case\">NPRS<\/jats:styled-content>) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (<jats:styled-content style=\"fixed-case\">FIQ<\/jats:styled-content>), Patient's Global Impression of Change (<jats:styled-content style=\"fixed-case\">PGIC<\/jats:styled-content>), and Medical Outcome Sleep questionnaires (<jats:styled-content style=\"fixed-case\">MOS<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on <jats:styled-content style=\"fixed-case\">NPRS<\/jats:styled-content> by end of 4\u00a0weeks (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001) on <jats:styled-content style=\"fixed-case\">NPRS<\/jats:styled-content>. Subjects also reported similar magnitude of improvements in <jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content> and its impact on daily life by end of 4\u00a0weeks on <jats:styled-content style=\"fixed-case\">FIQ<\/jats:styled-content> (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001). Survey of <jats:styled-content style=\"fixed-case\">MOS<\/jats:styled-content> showed our subjects reporting improved sleep quantity (on average, 1.2\u00a0hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in <jats:styled-content style=\"fixed-case\">PGIC<\/jats:styled-content>, with significant improvement in patient's impression of <jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content> by week 8.<\/jats:p><\/jats:sec><jats:sec><jats:title>Limitations<\/jats:title><jats:p>Small sample size, geographical bias, relatively short duration of treatment, and single\u2010arm study without control group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Extended\u2010release gabapentin relieved <jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content> pain symptoms and improved quality\u2010of\u2010life for the <jats:styled-content style=\"fixed-case\">FM<\/jats:styled-content> subjects studied. Subjects reported improvements in both quantity and quality of sleep.<\/jats:p><\/jats:sec>","DOI":"10.1111\/papr.12319","type":"journal-article","created":{"date-parts":[[2015,6,10]],"date-time":"2015-06-10T23:46:37Z","timestamp":1433979997000},"page":"720-729","source":"Crossref","is-referenced-by-count":15,"title":["The Effect of a Novel form of Extended\u2010Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open\u2010Label Pilot Study"],"prefix":"10.1111","volume":"16","author":[{"given":"James M.","family":"North","sequence":"first","affiliation":[{"name":"Carolinas Pain Institute and Center for Clinical Research Winston\u2010Salem North Carolina U.S.A"},{"name":"Wake Forest University Baptist Medical Center Pain Medicine and Anesthesiology Winston\u2010Salem North Carolina U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyung\u2010soo J.","family":"Hong","sequence":"additional","affiliation":[{"name":"The Center for Clinical Research Winston\u2010Salem North Carolina U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard L.","family":"Rauck","sequence":"additional","affiliation":[{"name":"Carolinas Pain Institute and Center for Clinical Research Winston\u2010Salem North Carolina 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