{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T18:40:10Z","timestamp":1784313610401,"version":"3.55.0"},"reference-count":51,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2024,12,31]],"date-time":"2024-12-31T00:00:00Z","timestamp":1735603200000},"content-version":"unspecified","delay-in-days":30,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Health and Medical Research Council (NHMRC) of Australia","award":["APP2023931"],"award-info":[{"award-number":["APP2023931"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,12,3]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Sciatica is a debilitating condition that often becomes chronic, and for which there are few effective treatment options. Treatments such as the anti-depressant duloxetine have shown promise, but the evidence is inconclusive. We are describing a high quality, definitive trial to investigate the efficacy, safety and cost-effectiveness of duloxetine in chronic sciatica.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The duloxetine for chronic sciatica (DREAM) trial is a randomised, superiority, parallel-group, placebo-controlled, triple-blinded (participant, clinician, assessor) trial with an adaptive group sequential design investigating the efficacy and safety of duloxetine in participants with chronic sciatica of at least 3 months duration. Participants will be randomised at a 1:1 ratio to duloxetine or placebo. 332 participants will be recruited on presentation to general practices, specialist clinics and hospital emergency departments or from hospital in-patient wards and from the community. In the active treatment group, participants will receive duloxetine 60 mg per day for 12 weeks, including 1 week of titration at 30 mg\/day. The treatment phase will be followed by a 2-week tapering phase where they will receive duloxetine 30 mg\/day. Participants will be followed-up for 1 year, with outcomes being measured 4, 8, 12, 16, 26, and 52 weeks post-randomisation. The primary outcome is leg pain intensity at 12 weeks post-randomisation. Secondary outcomes include back pain intensity, disability, time to recovery, quality of life, depressive and anxiety symptoms, and sleep disturbance. Adverse events will be recorded, and a cost-effectiveness analysis will be conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been granted by the University of Sydney Human Research Ethics Committee. Trial results will be disseminated by publications, conference presentations and via the media.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12624000919516.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-096796","type":"journal-article","created":{"date-parts":[[2024,12,31]],"date-time":"2024-12-31T11:30:24Z","timestamp":1735644624000},"page":"e096796","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["DREAM: an adaptive, randomised, placebo-controlled trial of duloxetine for reducing leg pain in people with chronic sciatica\u2014trial protocol"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-0895-3922","authenticated-orcid":false,"given":"Hanan","family":"McLachlan","sequence":"first","affiliation":[{"name":"Institute for 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