RecruitingACTRN12608000401358

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


Sponsor

Professor Nikolai Bogduk

Enrollment

240 participants

Start Date

Feb 1, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 0 N/As

Inclusion Criteria1

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

Exclusion Criteria1

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

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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

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.


Locations(1)

Australia

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ACTRN12608000401358