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
Inclusion Criteria5
- Adults (18 years old and above) with radiating pain into one leg in a dermatomal distribution
- Leg pain duration of at least three months
- Evidence of nerve root involvement, defined by the presence of at least ONE of the following clinical signs in the corresponding distribution: myotomal weakness and/or diminished reflex and/or sensory deficit and/or imaging evidence of nerve root impingement that is consistent with the clinical presentation.
- Leg pain that is at least moderate in intensity at the time of enrolment by a study doctor (as measured by a modified version of item 21 in the 36-Item Short Form Survey Instrument).
- An adequate understanding of English or the availability of interpretation services for the participant to complete the trial.
Exclusion Criteria10
- Known or suspected specific pathologies in the spine (e.g. fracture, cauda equina syndrome).
- Known or suspected malignancy.
- Having had spinal surgery or other interventional procedure (e.g. epidural injection) in the preceding 6 months.
- Scheduled to have a spinal procedure (e.g. spinal surgery, epidural injection) within 12 weeks at the time of enrolment.
- Currently using any antidepressant for any condition.
- Contraindications to duloxetine, including concomitant use of monoamine oxidase inhibitors, or if a monoamine oxidase inhibitor has been discontinued within less than 2 weeks, known acute or chronic liver disease, concomitant use with CYP1A2 inhibitors (e.g. fluvoxamine).
- Known history of chronic kidney disease stage 4 or above.
- Precautions for use of duloxetine as specified by the Product Information where risks outweigh potential benefits (e.g. depressive symptoms for which treatment is required as judged by the study doctor, bipolar disorder, history of seizure disorder, etc.).
- Previous severe adverse reaction to duloxetine (e.g. serotonin syndrome) as judged by the study doctor
- For females: pregnant, breastfeeding, or planning conception during the treatment period.
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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000919516