A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain: Evaluate Route Versus Pharmacology of Intervention, and Feasibility in Public Hospital and Community Practice Settings. (SCIATICA)

NCT03240783 Phase 2 UNKNOWN

Aim: In subjects with acute sciatica (≤ 4 weeks duration), this is a pilot comparative effectiveness study to evaluate feasibility and to determine final sample size for a future adequately powered randomised controlled trial of (i) CT-guided transforaminal lumbosacral epidural steroid injection, and (ii) oral dexamethasone, in a masked (blinded), randomised, sham injection and oral placebo controlled trial. Study Design: 60 patients with acute sciatica will randomised 1:1:1:1 to receive either (i) epidural steroid injection \& oral placebo, (ii) epidural normal saline injection \& oral placebo, (iii) oral dexamethasone \& IM sham-injection, (iv) IM sham-injection \& oral placebo. Outcomes: The primary outcome is reduction of disability at 3 weeks using the Oswestry Disability Index. Secondary outcomes include reduction of disability at 6 and 48 weeks.

Details

Lead sponsor	St George Hospital, Australia
Phase	Phase 2
Status	UNKNOWN
Enrolment	60
Start date	2017-07-08
Completion	2018-10

Conditions

• Acute Sciatica

Interventions

• Betamethasone OR Dexamethasone Injectable
• Normal Saline Flush, 0.9% Injectable Solution
• Dexamethasone Oral Tablet
• Sham Injection and/or oral placebo

Primary outcomes

• Oswestry Disability Index (ODI) version 2.0 — 3 weeks
  ODI is a functional status measure specifically developed for disorders of the spine

Countries

Australia