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.

Conditions

• Acute Sciatica

Interventions

DRUG

Betamethasone OR Dexamethasone Injectable

Procedural agents. The steroid and local anaesthetic preparation will be standardized to replicate current radiology interventional practices that use either particulate or non-particulate steroids. Betamethasone Sodium Phosphate/Acetate 5.7 mg/ml Injectable is a particulate corticosteroid and is used with the local anaesthetic bupivacaine 0.5% (1ml). Dexamethasone 4mg (1ml) is a non-particulate corticosteroid and is used with the local anaesthetic lignocaine 1% (1ml).

DRUG

Normal Saline Flush, 0.9% Injectable Solution

Procedural agents. The local anaesthetic preparation used with the Normal Saline Flush, 0.9% Injectable Solution, will be standardized to replicate current radiology interventional practices: either local anaesthetic bupivacaine 0.5% (1ml) or local anaesthetic lignocaine 1% (1ml).

DRUG

Dexamethasone Oral Tablet

Dexamethasone Oral Tablet: 15 day taper dosing is: days 1-5 8mg (4mg bd) , days 6-10 4 mg (2mg bd), and days 11-15 2 mg (1mg bd). The dexamethasone is over-encapsulated in a gelatine capsule that is identical to the placebo capsule in appearance.

OTHER

Sham Injection and/or oral placebo

The sham Injection procedure is needle placement down to muscle at the designated spinal level and no injection of any fluid. The oral placebo is a gelatine capsule packed with filler.

Sponsors & Collaborators

• St George & Sutherland Medical Research Foundation

  collaborator UNKNOWN

• St George Hospital, Australia

  lead OTHER

Principal Investigators

• Marissa Lassere, MBBS PhD · St George Hospital SESLHD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-08

Primary Completion

2017-12-31

Completion

2018-10-31

Countries

• Australia

Study Locations