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

NCT07557823 | Not Yet Recruiting

• 1 other identifier: 2025-1315
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Spondylosis; Radicular Pain; Cervical Radiculopathy

Keywords

taVNS; transcutaneous auricular vagus nerve stimulation; cervical epidural injection; cervical radiculopathy; pain; arm pain; pain management; neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Preoperative, 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

  Preoperative and post-procedure day 1

• Insomnia Severity Index (ISI) Score Changes

  Preoperative and post-procedure day 1

• Neck Disability Index (NDI) Score Changes

  Preoperative and post-procedure day 1

Study Arms (2)

taVNS + Cervical Epidural Injection

EXPERIMENTAL

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); Procedure: Cervical Epidural Injection

Sham taVNS + Cervical Epidural Injection

SHAM COMPARATOR

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); Procedure: Cervical Epidural Injection

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) BEHAVIORAL

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).

Sham taVNS + Cervical Epidural Injection; taVNS + Cervical Epidural Injection

Cervical Epidural Injection PROCEDURE

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

Sham taVNS + Cervical Epidural Injection; taVNS + Cervical Epidural Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Estimated procedure duration ≤ 1 hour.
• Able to understand and provide written informed consent.

You may not qualify if:

• 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.
• Severe psychiatric disorder or history of substance abuse.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Radiculopathy; Spondylosis; Pain; Agnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Lina Yu

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Yu, MD

CONTACT

1395803387; zryulina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study employs a double-blind design. Participants and outcome assessors are blinded to group assignment throughout the study. The intervention is administered by a dedicated research team member who is not involved in outcome assessment, ensuring blinding integrity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group, randomized, double-blind, sham-controlled trial. Eighty eligible participants will be randomly assigned in a 1:1 ratio to either the transcutaneous auricular vagus nerve stimulation (taVNS) combined with cervical epidural injection group or the sham taVNS combined with cervical epidural injection group. Both participants and outcome assessors will be blinded to group allocation throughout the study.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)