TY - JOUR
T1 - OASIS-a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica
T2 - trial protocol
AU - Liu, Chang
AU - Abdel Shaheed, Christina
AU - McLachlan, Andrew J.
AU - Latimer, Jane
AU - Li, Qiang
AU - Buchbinder, Rachelle
AU - Day, Richard O.
AU - Maher, Christopher G.
AU - Richards, Bethan
AU - Oliveira, Juliana S.
AU - Lin, Chung-Wei Christine
PY - 2020/6
Y1 - 2020/6
N2 - 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 AND ANALYSIS: 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. ETHICS AND DISSEMINATION: Ethical approval has been granted from the Human Research Ethics Committee, The University of Sydney. Trial results will be disseminated by publications and conference presentations and via the media. TRIAL REGISTRATION NUMBER: ACTRN12619001716156.
AB - 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 AND ANALYSIS: 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. ETHICS AND DISSEMINATION: Ethical approval has been granted from the Human Research Ethics Committee, The University of Sydney. Trial results will be disseminated by publications and conference presentations and via the media. TRIAL REGISTRATION NUMBER: ACTRN12619001716156.
KW - clinical trials
KW - musculoskeletal disorders
KW - pain management
KW - spine
UR - http://www.scopus.com/inward/record.url?scp=85087098567&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-040559
DO - 10.1136/bmjopen-2020-040559
M3 - Article
C2 - 32580990
AN - SCOPUS:85087098567
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e040559
ER -