drugset / Trial / NCT07813988

Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain

NCT07813988 ↗

Phase 4 Not yet recruiting 99 enrolled Benha University
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will compare three fluoroscopy-guided epidural steroid injection approaches for adults with unilateral lumbosacral radicular pain caused by lumbar disc herniation. The study will evaluate whether the pattern of contrast spread in the epidural space predicts meaningful pain relief. Ninety-nine participants will be randomly assigned in equal numbers to receive one of three treatments: high-volume parasagittal interlaminar injection, low-volume parasagittal interlaminar injection, or transforaminal epidural steroid injection. Participants will not be told which injection approach they receive. Pain and disability will be assessed before treatment and at 2 weeks, 1 month, 3 months, and 6 months after injection. The main outcome is the proportion of participants with clinically meaningful improvement in pain at 3 months.

Timeline

Start
2026-10
Primary completion
2027-11
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Betamethasone Other / unclassified 7.2 mg Other
Subject Betamethasone Other / unclassified 16.8 mg Other
Subject Betamethasone Other / unclassified 24 mg Other
Subject Bupivacaine Other / unclassified 6 mg Other
Subject Bupivacaine Other / unclassified 14 mg Other
Subject Bupivacaine Other / unclassified 20 mg Other