Poster Presentation Sydney Spinal Symposium 2024

Pharmacological management of acute and chronic sciatica: updates on the OASIS and DREAM placebo-controlled trials (#31)

Hanan McLachlan 1 2 , Giovanni E Ferreira 1 2 , Christopher G Maher 1 2 , Chung-Wei Christine Lin 1 2
  1. Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, NSW, Australia
  2. Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia

Background:

Sciatica is a debilitating symptom for which there are few effective treatment options. Sciatica is thought to have a good prognosis, but 40% of cases become chronic experiencing moderate or greater sciatic pain after 12 months due to prolonged compression or inflammatory irritation of the sciatic nerve. Though not commonly used, treatments such as glucocorticoids and antidepressants have shown promise. We describe the progress of two NHMRC-funded trials investigating the efficacy, safety and cost-effectiveness of prednisolone (OASIS) and duloxetine (DREAM) for acute and chronic sciatica, respectively.

 

Methods:

OASIS and DREAM are high-quality, double-blind, randomised, placebo-controlled, ethically approved and prospectively registered trials which include 12-months follow-up.

 

OASIS is a parallel-group, superiority trial. Participants with sciatic pain of no longer than 6 weeks are being randomised to a 13-day tapering regimen of oral prednisolone, starting with 3 days 50mg/day, or placebo. The primary outcome is leg pain intensity at 2 weeks.

 

DREAM is an adaptive, sample size re-estimation trial. Participants with sciatic pain for at least 3 months will be randomised to receive duloxetine 60mg/day for 12 weeks including a week of titration. The primary outcome is leg pain intensity at 12 weeks.

 

Results:

OASIS' original sample size was 200, but a planned interim data review showed a greater than anticipated standard deviation in the primary outcome. This prompted a recalculation and extension of the recruitment to 320 or the end of 2024 (projected time until trial funding is exhausted). 236 participants recruited as at 28/06/2024 (42% female, mean baseline leg pain intensity 6.2, mean symptom duration 22 days).

 

DREAM plans to recruit 332 participants over 2.5 years commencing Q3 2024. The protocol has ethics approval. Regulatory, site recruitment and operational processes are currently underway.

 

Conclusion:

If the interventions are effective, OASIS and DREAM can provide 2 medications that can relieve acute and chronic sciatica.