Oral and Poster Presentation ARA-NSW 2021 - 43rd Annual NSW Branch Meeting

OASIS—a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica: trial protocol (#18)

Chang Liu 1 , Christina Abdel Shaheed 1 , Andrew J McLachlan 2 , Jane Latimer 1 , Qiang Li 3 , Rachelle Buchbinder 4 , Richard O Day 5 , Christopher G Maher 1 , Bethan Richards 1 6 , Giovanni Ferreira 1 , Christine Lin 1
  1. Institute for musculoskeletal health, The University of Sydney, Sydney, NSW, Australia
  2. Sydney Pharmacy School, The Universiy of Sydney, Sydney, NSW, Australia
  3. The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
  4. Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  5. St Vincent’s Clinical School, University of New South Wales, Sydney, NSW, Australia
  6. Rheumatology Department, Institute of Rheumatology and Orthopaedics, Sydney, NSW, Australia

Introduction

Sciatica is a lower spine condition characterised by radiating leg pain below the knee. It may be accompanied by motor and sensory loss in the distribution of a spinal nerve. There are few effective treatments for sciatica. Orally administered glucocorticoids have shown some promise. However, any beneficial effects need to be confirmed and weighed against drug safety and cost-effectiveness in a high-quality, definitive trial.

Methods

The Oral Steroids In Sciatica (OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica. Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments and randomised to receive orally administered prednisolone 50 mg per day, up to 3 days then tapering to cessation over 10 days, or placebo, for a maximum of 13 days, in addition to guideline advice. Participants will be followed for 1 year. The primary endpoint will be leg pain intensity at 2 weeks. Secondary outcomes will include back pain intensity, disability, time to recovery, quality of life and treatment success rate. Adverse events will be assessed, and a cost-effectiveness analysis will be conducted. 

Results and conclusion

We plan to finish recruiting by the end of 2022. After one year period of follow-up, trial results will be analysed and disseminated by publications and conference presentations and via the media.