Abstract | INTRODUCTION: METHODS AND ANALYSIS: The primary outcome of this study will be to assess the tolerability and preliminary effectiveness of duloxetine in patients with acute musculoskeletal pain. The study will take place at two EDs in Rhode Island, USA. The study will involve randomisation to one of three arms: duloxetine 30 mg, duloxetine 60 mg or placebo. Tolerability will be assessed by comparing the proportion of participants that report an adverse event and that drop-out across the three study arms. Effectiveness will be determined by self-reported pain over 6 weeks of follow-up. Specifically, we will compare the proportion of participants with persistent pain (ongoing pain at 6-week follow-up), across the three study arms. 60 adults (aged 18-59) presenting to the ED with acute axial musculoskeletal pain within 7 days of onset are expected to be enrolled in the proposed study. ETHICS AND DISSEMINATION: Ethics approval was obtained by the Institutional Review Board (IRB). These results will be published in a peer reviewed scientific journal and presented at one or more scientific conferences. TRIAL REGISTRATION NUMBER: NCT03315533.
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Authors | Daniel H Strauss, Divya R Santhanam, Samuel A McLean, Francesca L Beaudoin |
Journal | BMJ open
(BMJ Open)
Vol. 9
Issue 3
Pg. e025002
(03 05 2019)
ISSN: 2044-6055 [Electronic] England |
PMID | 30842115
(Publication Type: Clinical Trial Protocol, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Chemical References |
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
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Topics |
- Acute Pain
(drug therapy)
- Adult
- Chronic Pain
(prevention & control)
- Double-Blind Method
- Duloxetine Hydrochloride
(administration & dosage)
- Female
- Humans
- Male
- Middle Aged
- Musculoskeletal Pain
(diagnosis, drug therapy)
- Pain Management
(methods)
- Pain Measurement
- Serotonin and Noradrenaline Reuptake Inhibitors
(administration & dosage)
- Treatment Outcome
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