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

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Combined With Cervical Epidural Injection in the Treatment of Cervical Radiculopathy: A Randomized, Double-Blind, Sham-Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Radiculopathy; Cervical Spondylosis; Radicular Pain
• Intervention / Treatment: Behavioral: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Procedure: Cervical Epidural Injection

Detailed Description

Cervical radiculopathy is a common condition associated with significant neck and arm pain, often resulting from cervical spondylosis. Current management strategies include epidural injections and pharmacotherapy; however, adjunctive neuromodulation therapies are being explored. This study aims to evaluate the additive effect of taVNS, a non-invasive neuromodulation technique, when combined with cervical epidural injection.

Study Design:

Eighty patients diagnosed with cervical radiculopathy scheduled for cervical epidural injection will be recruited. Participants will be randomly allocated in a 1:1 ratio to two groups:

• Experimental Group: Subjects will receive 3 consecutive days of preoperative taVNS stimulation (1-2 hours/day, 30Hz, 200μs, up to 50mA) followed by a standard cervical epidural injection of corticosteroid and local anesthetic.
• Control Group: Subjects will receive a sham taVNS stimulation (identical device with no output) for the same duration and frequency, followed by the same standard cervical epidural injection.

Outcomes:

The primary endpoint is the proportion of subjects achieving a ≥50% reduction in NRS pain score at discharge. Secondary endpoints include changes in Brief Pain Inventory (BPI) scores, Hospital Anxiety and Depression Scale (HADS) scores, Insomnia Severity Index (ISI) scores, Neck Disability Index (NDI), and heart rate variability (HRV) measurements at predefined time points (preoperatively, 24 hours postoperatively, and at discharge). Safety outcomes include the incidence of adverse events and changes in cardiac function.

This study will provide high-level evidence on the efficacy and safety of combining taVNS with cervical epidural injection for the treatment of acute cervical radiculopathy.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Yu, MD; Phone Number: 1395803387; Email: zryulina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital, Zhejiang University School of Medicine Facility Address 88 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang Province, 310009, P.R.China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 and 85 years old.
2. Body Mass Index (BMI) between 18 and 35 kg/m².
3. American Society of Anesthesiologists (ASA) physical status I to III.
4. Diagnosed with cervical radiculopathy, scheduled for selective cervical epidural injection.
5. Estimated procedure duration ≤ 1 hour.
6. Able to understand and provide written informed consent.

Exclusion Criteria:

1. Arrhythmia requiring treatment, severe bradycardia, or postural orthostatic tachycardia syndrome.
2. Neuromuscular disorders or auricular dermatitis.
3. Cervical fracture, tumor, tuberculosis, or active infection confirmed by imaging.
4. Contraindications to vagus nerve stimulation: carotid sinus hypersensitivity, bilateral carotid artery stenosis.
5. Severe psychiatric disorder or history of substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS + Cervical Epidural Injection; Participants in this group receive 3 consecutive days of preoperative transcutaneous auricular vagus nerve stimulation (taVNS), 1-2 hours per day. The electrode is placed on the left cymba conchae, with parameters set at 30Hz frequency, 200μs pulse width, and current titrated to patient tolerance (maximum 50mA). This is combined with a standard cervical epidural injection of corticosteroid and local anesthetic.	Behavioral: 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).; Procedure: Cervical Epidural Injection; Standard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.
Sham Comparator: Sham taVNS + Cervical Epidural Injection; Arm Description Participants in this group receive sham taVNS using an identical-appearing inactive device, applied at the same auricular region, for the same duration and frequency as the experimental group.	Behavioral: 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).; Procedure: Cervical Epidural Injection; Standard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative, 24 hours postoperatively, and post-procedure day 1	Changes in Brief Pain Inventory (BPI) scores, including worst, least, average, and current pain intensity, as well as pain interference with daily activities, measured from preoperative baseline to 24 hours postoperatively and post-procedure day 1.	Preoperative, 24 hours postoperatively, and post-procedure day 1
Hospital Anxiety and Depression Scale (HADS) Score Changes	Changes in Hospital Anxiety and Depression Scale (HADS) scores, including anxiety and depression subscales, measured from the preoperative baseline to post-procedure day 1 to evaluate psychological status.	Preoperative and post-procedure day 1
Insomnia Severity Index (ISI) Score Changes	Changes in Insomnia Severity Index (ISI) scores, measured from the preoperative baseline to post-procedure day 1, to evaluate improvements in sleep quality.	Preoperative and post-procedure day 1
Neck Disability Index (NDI) Score Changes	Changes in Neck Disability Index (NDI) scores, measured from the preoperative baseline to post-procedure day 1, to evaluate improvements in neck function and daily activity ability.	Preoperative and post-procedure day 1

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Lina Yu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain; transcutaneous auricular vagus nerve stimulation; neuromodulation; pain management; taVNS; arm pain; cervical epidural injection; cervical radiculopathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neurobehavioral Manifestations; Spinal Diseases; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Radiculopathy; Spondylosis; Agnosia
• Other Study ID Numbers: 2025-1315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No