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.
The University of Sydney
200 participants
Feb 20, 2021
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
Inclusion Criteria1
- Adults with acute sciatica (no more than 6 weeks since onset) of at least moderate pain intensity in leg pain or results in at least moderate interference with daily activities during the previous week. Sciatica is defined as radiating pain into one leg below the knee, accompanied by lumbar nerve root or spinal-nerve involvement as indicated by the presence of at least one of these clinical features: dermatomal leg pain, myotomal weakness, sensory deficits, or diminished reflex.
Exclusion Criteria1
- Known or suspected serious disease of the spine (e.g. cauda equina syndrome); planning to undergo spinal surgery or other interventional procedures (e.g. an epidural injection) for sciatica during the treatment period; having had spinal surgery or other interventional procedures (e.g. an epidural injection) in the preceding 6 months; having used a systemic glucocorticoid (for any condition) via any method of administration since the start of this episode of sciatica; contraindications to glucocorticoids (e.g. known allergy to prednisolone, active infection, diabetes, pre-diabetes and previous history of gestational diabetes, active gastrointestinal bleeding (peptic ulcer), uncontrolled hypertension and heart failure, psychosis, immunosuppression) or precautions to glucocorticoids where risks outweigh potential benefits; for females: pregnant, breast-feeding, or planning conception during the treatment period.
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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 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)
View Full Details on ANZCTR
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ACTRN12619001716156