A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain
Summary
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.
Timeline
- Start
- 2017-07-08
- Primary completion
- 2017-12
- Completion
- 2018-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betamethasone | Other / unclassified | 5.7 mg | Other |
| Subject | Dexamethasone | Small molecule | 2 mg | Other |
| Subject | Dexamethasone | Small molecule | 4 mg | Other |
| Background | Bupivacaine | Other / unclassified | 0.5 % | Other |
| Background | Lidocaine | Other / unclassified | 1 % | Other |