Acute Sciatica Clinical Trial
Official title:
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.
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.
Acute sciatica, a major cause of pain and disability, is a common presentation to medical
practices and hospitals. Up to 25% of patients do not recover after 12 months. Sciatica
refers to radicular pain and radiculopathy from lumbosacral nerve root pathology caused by
lumbosacral disc herniation and degenerative lumbosacral spondylosis involving the L2/3 to
L5/S1 intervertebral discs and foramina. Selective transforaminal epidural steroid injection
and systemic steroids are therapeutic options in patients who do not improve with
conservative management. However, there is limited evidence of effectiveness of these
treatments in acute sciatica.
This pilot study is designed to evaluate the following feasibility and study conduct issues:
type and standardization of interventions and associated sham and placebo control,
appropriateness of inclusion and exclusion criteria, rate of recruitment, study conduct
including randomisation allocation concealment, successful masking, wait time for delivery of
services (allied health, diagnostic imaging, and procedures), and ensuring efficient,
appropriate and safe study conduct for recruitment from emergency departments, hospital
inpatients, general practitioners and specialists in the community, and radiology departments
in hospital and community practices. Study logistics will differ across these settings, and
processes to ensure standardization will be evaluated. Other issues explored include
co-therapy with analgesics, NSAIDS, pregabalin, physical and manual therapies, and the timing
of rescue therapy, including neurosurgery. It is our experience with previous RCTs that
piloting all facets and procedures is essential for the successful conduct of a RCT.
Furthermore, results of the categorical and continuous primary and secondary outcomes from
this pilot RCT will be used to calculate the sample size of an adequately powered RCT to
determine which treatments currently used in the management of acute sciatica/lumbosacral
radiculopathy of less than 4 weeks duration, is the most effective in reducing pain and
disability in the short-term and prevent progression to persistent or recurrent
sciatica/lumbosacral radiculopathy in the long term.
Study Design: 60 patients with acute sciatica will randomised 1:1:1:1
Arm 1: CT - fluoroscopic guided transforaminal lumbar epidural steroid (1 ml) mixed with
local anaesthetic (1 ml) (Active Intervention) AND oral placebo taper (Placebo Control) Note:
The injectable steroid and local anaesthetic preparation is standardized to replicate current
practice: EITHER (i) betamethasone injectable 5.7 (1ml), a particulate corticosteroid with
the local anaesthetic bupivacaine 0.5% (1ml) OR (ii) dexamethasone injectable 4mg (1ml) a
non-particulate corticosteroid with local anaesthetic lignocaine 1% (1ml).
Arm 2: CT - fluoroscopic guided transforaminal lumbar epidural normal saline (1 ml) mixed
with local anaesthetic (1ml) (Active Intervention controlling for pharmacology) AND oral
placebo taper (Placebo Control) Note: The Normal Saline is a Normal Saline flush 0.9%
injectable solution. The local anaesthetic preparation is standardized to replicate current
practice: EITHER (i) bupivacaine 0.5% (1ml) OR (ii) lignocaine 1% (1ml).
Arm 3: Oral dexamethasone taper (Active Intervention) AND sham injection (Sham Control) Oral
dexamethasone taper is a 15 day tapered dosing: (i) days 1-5, dexamethasone 4 mg morning and
evening, (ii) days 6-10, dexamethasone 2 mg morning and evening, and (iii) days 11-15,
dexamethasone 1mg morning and evening. The dexamethasone gelatine capsule is identical to the
placebo capsule in appearance. The sham injection is CT/fluoroscopic guided (with parameters
set to zero) lumbar sham injection. The needle placement is down to muscle layer but NOT into
the epidural space, and there is no injection of any fluid.
Arm 4: Sham injection (Sham Control) AND oral placebo taper (Placebo Control) The sham
injection is CT/fluoroscopic guided (with parameters set to zero) lumbar sham injection. The
needle placement is down to muscle layer but NOT into the epidural space, and there is no
injection of any fluid. The oral placebo is a gelatine capsule with filler. It is identical
to the dexamethasone capsule in appearance.
Participants: If eligibility criteria are met then participants will be invited to
participate in the RCT. If the participant agrees, then the participant proceeds down study
pathway. A log of all potential participants who are referred and screened and who either
decline to participate in the RCT or deemed ineligible by the eligibility criteria will be
kept. This will ascertain the representativeness of those who consent to be randomized,
consistent with CONSORT guidelines. Data collected in the refusal/reject log will include
age, gender, reason(s) for ineligibility or refusal, and, if available, pain/disability score
and treatment.
Outcomes: The primary outcome is reduction of disability at 3 weeks using the
condition-specific Oswestry Disability Index (ODI). Secondary outcomes include reduction of
disability at 6 and 48 weeks on (ODI), Numerical Rating Scale (NRS) for leg pain and for back
pain respectively, measures of generic function/disability and quality of life (SF-36,
EQ-5D), length of hospital stay, medication co-therapy use (simple analgesics, opiate
analgesics, pregabalin, and NSAIDs), need for rescue procedures or surgery, time to return to
work (if applicable), compliance with treatment, masking success, measures of study conduct
and efficiency, and adverse events.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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N/A | |
| Recruiting |
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