Ultrasound-guided transforaminal epidural injection with fluoroscopy confirmation for the treatment of unilateral lumbar radiculopathy: A randomized controlled non-inferiority study

Wenxing Zhao; Guili Guo; Qi Wang; Liqiang Yang

doi:10.1016/j.clineuro.2023.107849

Ultrasound-guided transforaminal epidural injection with fluoroscopy confirmation for the treatment of unilateral lumbar radiculopathy: A randomized controlled non-inferiority study

Clin Neurol Neurosurg. 2023 Aug:231:107849. doi: 10.1016/j.clineuro.2023.107849. Epub 2023 Jun 23.

Authors

Wenxing Zhao¹, Guili Guo², Qi Wang¹, Liqiang Yang³

Affiliations

¹ Department of Pain Management, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Xicheng District, Beijing 100053, China.
² Stroke Acute Care Center, Department of Pain Management, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Xicheng District, Beijing, China.
³ Department of Pain Management, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Xicheng District, Beijing 100053, China. Electronic address: ylqpainmanagement@outlook.com.

PMID: 37385126
DOI: 10.1016/j.clineuro.2023.107849

Abstract

Background: Ultrasound (US)-guided injections for chronic pain has multiple advantages over traditional radiologic method. The study was performed to exam the clinical outcomes of lumbar transforaminal epidural injection (LTFEI) between US and fluoroscopy (FL) guidance for lumbar radiculopathy (LRP).

Methods: A total of 164 patients with LRP were randomly assigned into US and FL group to receive LTFEI in a 1:1 ratio. Pain relief and functional disability were assessed by numeric rating scale (NRS) and Modified Oswestry Disability Questionnaire (MODQ) scores before treatment, 1 month and 3 months post-intervention. Contrast spread pattern, fluoroscopic image number and complications were also recorded. The primary outcome was accurate rate of contrast dispersing into lumbar epidural space, and non-inferiority margin was predefined at -15 %.

Results: The accuracy of LTFEI was 90.2 % and 91.5 % in US and FL group, and the lower limit of the 95 %CI of mean difference between two modalities (-4.9 % (95 %CI: -12.8 %, 3.1 %)) was above the non-inferiority margin. Procedure time in US group (531.90 ± 67.12 s) was shorter than FL group (904.20 ± 120.20 s) (p < 0.05), while radiation dosage in the US group was lower than in the FL group (3047.20 ± 569.53 vs. 8807.50 ± 1039.10 μGy m², p < 0.001). Both groups didn't differ in pain reduction (F = 1.050, p = 0.306) and functional improvement (F = 0.103, p = 0.749) during follow-up period. No severe complications occurred in both groups.

Conclusions: US-guided LTFEI confirmed by FL was not inferior to conventional FL method in terms of accurate rate of lumbar epidural contrast dispersion. Effective pain relief and functional ability improvement were comparable between two modalities, and US technique had advantages of less radiation exposure and possible facilitation of avoiding critical vessels around intervertebral foramen.

Keywords: Fluoroscopy guidance; Lumbar radiculopathy; Radiation exposure; Transforaminal epidural injection; Ultrasound guidance.

Publication types

Randomized Controlled Trial

MeSH terms

Fluoroscopy / methods
Humans
Injections, Epidural
Low Back Pain* / diagnostic imaging
Low Back Pain* / drug therapy
Lumbar Vertebrae / diagnostic imaging
Radiculopathy* / diagnostic imaging
Radiculopathy* / drug therapy
Treatment Outcome
Ultrasonography, Interventional