Duloxetine for chronic sciatica (DREAM): an adaptive randomised placebo-controlled trial
DREAM: an adaptive randomised placebo-controlled trial of duloxetine compared to placebo for reducing leg pain in people with chronic sciatica
The University of Sydney
332 participants
Feb 12, 2025
Interventional
Conditions
Summary
Sciatica affects many Australians every year, and half of the people who develop sciatica report having persisting pain of at least moderate intensity after 1 year. There are no simple, readily available treatments for patients with chronic sciatica. Identifying a simple low-cost treatment for chronic sciatica would be a major advance in the field. We have shown that the antidepressant duloxetine is a promising, accessible, low-cost treatment for chronic sciatica. However, the is considerable uncertainty about its efficacy. We will conduct the DREAM trial, which will provide a definitive answer about the efficacy duloxetine for chronic sciatica.
Eligibility
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Interventions
Duloxetine in addition to usual care Participants randomised to the active arm of the study will receive a 12-week course of oral duloxetine followed by a 2-week tapering phase. The starting dose will be 30 mg/day for 1 week (one 30 mg capsule per day), increasing to 60 mg/day for 11 weeks (maintenance phase – two 30 mg capsules per day). In the 2-week tapering phase, they will receive 30 mg/day (one 30 mg capsule per day) for 2 weeks before treatment is discontinued. Study doctors will be allowed to make modifications to the treatment regimen if required. Participants in this group will also receive guideline-recommended advice (eg NICE). Adherence to study medication will be measured by participants’ self-report of daily medication intake, recorded in a diary or online, and by counting the returned medications, against the study doctor’s prescription record.
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ACTRN12624000919516