RecruitingPhase 4ACTRN12624000919516

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


Sponsor

The University of Sydney

Enrollment

332 participants

Start Date

Feb 12, 2025

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Sciatica is a shooting or burning pain that travels down one leg, caused by irritation of the nerves coming out of the lower spine. For many people it resolves within weeks, but roughly half of those who develop it still have significant pain a year later — and options for treating chronic sciatica are limited. This study is testing whether duloxetine, an antidepressant that also works on pain pathways in the nervous system, can meaningfully reduce leg pain in people with chronic sciatica. The DREAM trial is a large, well-designed randomised placebo-controlled study that will definitively answer whether duloxetine works for this condition. Participants will be randomly assigned to receive either duloxetine or a placebo tablet, and will be followed over time to track their pain levels and quality of life. Adults aged 18 or older who have had radiating leg pain for at least three months, with signs of nerve root involvement confirmed by clinical examination or imaging, and moderate or severe leg pain at the time of enrolment may be eligible. You must not currently be taking any antidepressants and must be able to communicate adequately in English. People who have had recent spinal surgery, a planned spinal procedure within 12 weeks, serious kidney or liver disease, or contraindications to duloxetine are not eligible. The trial is led by the University of Sydney.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 w

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12624000919516


Related Trials