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

Plain Language Summary

Simplified for easier understanding

This study is comparing five different types of spinal injections used to treat sciatica — severe leg pain caused by a pinched or irritated nerve in the lower back. The goal is to find out which injection provides the most pain relief and functional improvement, and for how long. Participants will be randomly assigned to receive one of the five injection types. You may be eligible if: - You are 18 years of age or older - You have radicular (radiating) leg pain (sciatica) - You have a disc herniation (slipped disc) confirmed on CT or MRI scan You may NOT be eligible if: - There are anatomical barriers that prevent a safe injection - You are pregnant - You have a known allergy to local anaesthetic or contrast dye (used during the procedure) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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