About this trial
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 criteria
Qualifiers
Age between 18 and 85 years old.
Body Mass Index (BMI) between 18 and 35 kg/m².
American Society of Anesthesiologists (ASA) physical status I to III.
Diagnosed with cervical radiculopathy, scheduled for selective cervical epidural injection.
Disqualifiers
Arrhythmia requiring treatment, severe bradycardia, or postural orthostatic tachycardia syndrome.
Neuromuscular disorders or auricular dermatitis.
Cervical fracture, tumor, tuberculosis, or active infection confirmed by imaging.
Contraindications to vagus nerve stimulation: carotid sinus hypersensitivity, bilateral carotid artery stenosis.
Trial design
Treatments tested in this trial
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Cervical Epidural Injection