DREAM: an adaptive, randomised, placebo-controlled trial of duloxetine for reducing leg pain in people with chronic sciatica-trial protocol
- PMID: 39740937
- PMCID: PMC11749743
- DOI: 10.1136/bmjopen-2024-096796
DREAM: an adaptive, randomised, placebo-controlled trial of duloxetine for reducing leg pain in people with chronic sciatica-trial protocol
Abstract
Introduction: 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.
Methods and analysis: 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.
Ethics and dissemination: 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.
Trial registration number: ACTRN12624000919516.
Keywords: Chronic Pain; Clinical trials; Musculoskeletal disorders; Neurological pain.
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ Group.
Conflict of interest statement
Competing interests: The study has been awarded funding from the NHMRC, Australia. The investigators maintain full autonomy in the design, conduct and reporting of the study. We have ethics approval to reimburse study clinicians and participants for their time spent on study-specific tasks. NBF has received consultancy fees from PharmNovo, Vertex, NeuroPN, Saniona, Nanobiotix and Neurvati and has undertaken consultancy work for Aarhus University with remunerated work for AKIGAI, Biogen, Merz and Confo Therapeutics, and she has received grants from IMI2PainCare an EU IMI 2 (Innovative medicines initiative) public-private consortium, and the companies involved are: Grünenthal, Bayer, Eli Lilly, Esteve and Teva, outside the submitted work. MU is the chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research and is a co-investigator on grants funded by the Australian NHMRC and Norwegian MRC. He is a director and shareholder of Clinvivo Ltd. that provides electronic data collection for health services research. He receives some salary support from University Hospitals Coventry and Warwickshire. He is a co-investigator on two current and one completed NIHR funded studies that have, or have had, additional support from Stryker Ltd. He has accepted travel expenses for speaking at academic meetings.
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