RecruitingPhase 4ACTRN12619001716156

Oral steroids in sciatica: The OASIS Randomised Controlled Trial

OASIS, a two-arm, double-blind randomised controlled trial of oral steroids in addition to usual care compared to placebo for reducing leg pain in patients with acute sciatica.


Sponsor

The University of Sydney

Enrollment

200 participants

Start Date

Feb 20, 2021

Study Type

Interventional

Conditions

Summary

This study aims to investigate the efficacy of oral glucocorticoids in reducing leg pain intensity in people with acute sciatica. Participants will be randomised to receive either active medication (oral prednisolone) or placebo for up to 13 days (from commencement to cessation). We hypothesise that orally administered glucocorticoids will produce a clinically worthwhile improvement in leg pain.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Sciatica is a sharp, often debilitating pain that radiates down the leg — usually caused by a compressed or irritated nerve root in the lower back. It can make standing, walking, and sleeping very difficult. While many cases improve on their own, the pain can be severe in the short term, and finding treatments that provide rapid relief is important. This randomised controlled trial, called OASIS, is testing whether a short course of oral prednisolone (a corticosteroid, or steroid anti-inflammatory tablet) taken for up to 13 days can meaningfully reduce leg pain compared to a placebo. Steroids work by reducing the inflammation around the compressed nerve, which is believed to be a key driver of sciatica pain. You may be eligible if you are an adult who has had sciatica for 6 weeks or less, with at least moderate leg pain, and signs of nerve involvement (such as pain going below the knee, numbness, or weakness). People with serious spinal conditions, who have already had recent spinal injections or surgery, have diabetes, active infection, uncontrolled high blood pressure, a history of stomach ulcers, or who are pregnant or breastfeeding are not eligible.

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

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Interventions

Oral prednisolone plus guideline-recommended advice. Initial dose of 50 mg/day for a maximum 3 days, followed by 25 mg/day for a maximum of 5 days, then 12.5mg/day for a maximum of 5 days before comp

Oral prednisolone plus guideline-recommended advice. Initial dose of 50 mg/day for a maximum 3 days, followed by 25 mg/day for a maximum of 5 days, then 12.5mg/day for a maximum of 5 days before complete cessation. The maximum duration from commencement to cessation will be 13 days and the maximum cumulative dose 337.5 mg. The dose can be adjusted by the study doctor depending on individual progress and tolerability. For example, if a participant experiences side effects (e.g. difficulty sleeping), the initial dose can be lowered to 25 mg per day. If a participant reaches ‘adequate improvement’ (0 to 1 out of 10 pain for three consecutive days), dose reduction can start earlier. Adherence to study medication will be monitored by a self-report daily medication diary and by counting the returned medications against the doctor’s prescription record. Additionally, all participants will receive guideline-recommended advice from their study doctor, such as patient reassurance (of the benign pathology and prognosis), staying active and avoiding bed rest and complex medicines.


Locations(1)

NSW, Australia

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