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Randomised controlled trial of transforaminal injections for sciatica

Randomised controlled trial of transforaminal injections for the relief of lumbar radicular pain caused by lumbar disc herniation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000401358
Enrollment
240
Registered
2008-08-12
Start date
2007-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Five different injections are purported to be effective for lumbar radicular pain. Each has its advocates but each lacks convincing scientific data. This study is designed to test which of these injections is effective, for relieving pain and restoring function, in the greatest proportion of patients and for the longest duration.

Interventions

Patients are randomised by random number allocation to one of five treatment groups. Each receives an injection under fluoroscopic guidance. In three groups the needle is placed in the intervertebral foramen that lodges the affected nerve. Respectively those groups are randomly injected with (1) 0.75ml of a local anaesthetic (0.5% bupivacaine) followed by a steroid preparation (1.75 ml triamcinolone 40mg/ml) or (2) 2ml bupivacaine 0.5% or (3) 2ml normal saline. In two other groups the needle is

Patients are randomised by random number allocation to one of five treatment groups. Each receives an injection under fluoroscopic guidance. In three groups the needle is placed in the intervertebral foramen that lodges the affected nerve. Respectively those groups are randomly injected with (1) 0.75ml of a local anaesthetic (0.5% bupivacaine) followed by a steroid preparation (1.75 ml triamcinolone 40mg/ml) or (2) 2ml bupivacaine 0.5% or (3) 2ml normal saline. In two other groups the needle is placed deeply in the back muscles opposite the segment affected by the disc herniation. They receive either 1.75 ml triamcinolone 40mg/ml or 2 ml normal saline. All patients receive at least one therapeutic injection, but are entitled to have one or two repeats of the allocated agent if their response is favourable but partial, and they wish to boost their response.

Sponsors

Professor Nikolai Bogduk
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

radicular pain and disc herniation demonstrated on computerised tomography (CT) or magnetic resonance imaging (MRI)

Exclusion criteria

anatomical barriers to safe executaion of injection, preganancy, allergy to local anaesthetic or contrast medium

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026