An open-label non-inferiority randomized trail comparing the effectiveness and safety of ultrasound-guided selective cervical nerve root block and fluoroscopy-guided cervical transforaminal epidural block for cervical radiculopathy

Abstract

Object: To compare therapeutic efficacy and safety of ultrasound (US)-guided selective nerve root block (SNRB) and fluoroscopy (FL)-guided transforaminal epidural steroid injection (TFESI) for cervical spine radiculopathy (CSR). Method: 156 patients with CSR randomly received US-guided SNRB verified by FL or FL-guided TFESI. We hypothesised that the accuracy rate of contrast dispersion into epidural or intervertebral foraminal space in the US group was not inferior to that in the FL group with a margin of clinical unimportance of −15%. Pain intensity assessed by Numeric Rating Scales (NRS) and functional disability estimated by neck disability index (NDI) were compared before treatment, at 1, 3 and 6 months after the intervention. Puncture time and complication frequencies were also reported. Results: 88.7% and 90.3% accuracy ratings were respectively achieved in the US and FL groups with a treatment difference of −1.6% (95%CI: −9.7%, 6.6%) revealing that the lower limit was above the non-inferiority margin. Both NRS and NDI scores illustrated improvements at 1, 3 and 6 months after intervention with no statistically significant differences between the two groups (all p >.05). Additionally, shorter administration duration was observed in the US group (p