Supraneural versus Infraneural Approach to transforaMinal Epidural StEroid injection for unilateral lumbosacral radicular pain (SIAMESE): a study protocol for a randomised non-inferiority trial

BJA Open · 5 authors, 2 centres

AI SUMMARY

FIDELITY 100%

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

This is a study protocol for a randomised, single-blinded, non-inferiority trial comparing two needle approaches for transforaminal epidural steroid injection to treat lumbosacral radicular pain. The primary goal is to determine if the infraneural approach is not inferior to the standard supraneural approach for pain reduction at 3 months.

Full summary

654 CHARS

The paper describes the protocol for a randomised, single-blinded, non-inferiority trial designed to compare the infraneural and supraneural approaches to transforaminal epidural steroid injection for unilateral lumbosacral radicular pain. The study will recruit 92 adult patients with pain lasting over 3 months. The primary outcome is the difference in average pain intensity (NRS) at 3 months. Secondary outcomes include disability, function, sleep, activity, and adverse events, followed for 12 months. The protocol notes the supraneural approach carries a rare risk of catastrophic arterial injury, while the infraneural approach aims to avoid this.

STUDY TYPE

RCT

SPECIALTY

neurology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10430835

Supraneural versus Infraneural Approach to transforaMinal Epidural StEroid injection for unilateral lumbosacral radicular pain (SIAMESE): a study protocol for a randomised non-inferiority trial

BJA Open

READ THE FULL PAPER

ABSTRACT

Background Lumbosacral radicular pain is commonly treated by transforaminal steroid epidural injection. There are two methods: the supraneural and the infraneural approaches. The supraneural approach can result in rare but catastrophic consequences from injury to the radiculomedullary artery. The infraneural technique avoids the artery; both approaches show efficacy and are used locally. Methods This is a protocol for a randomised, single-blinded, non-inferiority trial of infraneural vs supraneural transforaminal epidural injection for lumbosacral radicular pain at a tertiary referral pain management clinic. Adult patients ( n =92) with moderate-to-severe lumbosacral radicular pain of >3 months duration, scheduled for transforaminal epidural steroid injection, will be randomised to epidural by either the infraneural or supraneural approach. Only the treating physicians will know which route is used. The primary outcome measure is the differential impact on pain intensity score at 3 months. Secondary outcome measures will include disability and function scores, sleep and activity measures, and adverse events. Participants will be followed up for 12 months. Conclusions This study will determine whether the techniques are comparable and, if so, will enable recommendations for the use of an approach without risk of artery damage and catastrophic injury. Clinical trial registration ISRCTN 36195887.

CITATION EXPORT

Helen F. Galley, Rosalind Adam, Malachy O. Columb et al.. Supraneural versus Infraneural Approach to transforaMinal Epidural StEroid injection for unilateral lumbosacral radicular pain (SIAMESE): a study protocol for a randomised non-inferiority trial. BJA Open. (2023). https://doi.org/10.1016/j.bjao.2023.100126

AUTHORS

5 · 2 CENTRES

Helen F. Galley, Rosalind Adam, Malachy O. Columb, Uzunma M. Onyeakazi, Saravanakumar Kanakarajan

1School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK
2Manchester University Hospitals Trust, Wythenshawe, UK