Transcutaneous Auricular Vagus Nerve Stimulation Combined With Cervical Epidural Injection for Cervical Radiculopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Preoperative non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) administered for 3 consecutive days, 1-2 hours daily. Electrode placed on the left cymba conchae. Parameters: 30Hz frequency, 200μs pulse width, current titrated to patient tolerance (max 50mA).

Cervical Epidural Injection: Standard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.

Study summary

This is a prospective, randomized, double-blinded, sham-controlled trial conducted to investigate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) combined with cervical epidural injection in the treatment of cervical radiculopathy. A total of 80 subjects will be enrolled and randomly assigned (1:1) to either the experimental group or the control group. The primary outcome measure is the proportion of subjects with a ≥50% reduction in the Numerical Rating Scale (NRS) pain score at discharge. Secondary outcomes include pain intensity, pain interference, psychological status, sleep quality, physical disability, and autonomic function measurements. Adverse events will be monitored throughout the study.

Eligibility

Primary outcome measure(s)

• Proportion of Participants Achieving ≥50% Reduction in NRS Pain Score — Post-procedure Day 1
  The proportion of participants achieving a ≥50% reduction in Numerical Rating Scale (NRS) pain score from baseline to the post-procedure day 1 assessment.

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China