Cervical RadiculopathyNCT07557823
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Cervical Epidural Injection for Cervical Radiculopathy
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Cervical Epidural Injection in people with Cervical Radiculopathy and Cervical Spondylosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Spondylosis, Radicular Pain
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Cervical Epidural Injection
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Radiculopathy, Cervical Spondylosis, Radicular Pain
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Cervical Epidural Injection
- Keywords
- taVNS, transcutaneous auricular vagus nerve stimulation, cervical epidural injection; cervical radiculopathy, pain, arm pain, pain management, neuromodulation
- Medical subject headings
- Radiculopathy, Spondylosis, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Behavioural
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 InjectionProcedure or surgery
Standard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Procedure: Cervical Epidural Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-procedure Day 1
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperative and post-procedure day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lina Yu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557823
- Sponsor's protocol ID
- 2025-1315
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Combined With Cervical Epidural Injection in the Treatment of Cervical Radiculopathy: A Randomized, Double-Blind, Sham-Controlled Trial.
- ClinicalTrials.gov ID
- NCT07557823
- Acronym / sponsor ID
- 2025-1315
- Conditions
- Cervical Radiculopathy, Cervical Spondylosis, Radicular Pain
- Keywords
- taVNS, transcutaneous auricular vagus nerve stimulation, cervical epidural injection; cervical radiculopathy, pain, arm pain, pain management, neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| taVNS + Cervical Epidural Injection | Experimental | Behavioral: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Procedure: Cervical Epidural InjectionParticipants 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. |
| Sham taVNS + Cervical Epidural Injection | Sham comparator | Behavioral: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Procedure: Cervical Epidural InjectionArm 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Sham taVNS + Cervical Epidural Injection, taVNS + Cervical Epidural Injection |
| Cervical Epidural InjectionStandard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine. | Procedure or surgery | Sham taVNS + Cervical Epidural Injection, taVNS + Cervical Epidural Injection |
Primary outcome
Proportion of Participants Achieving ≥50% Reduction in NRS Pain Score
Time frame: 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.
4 secondary outcomes
Preoperative, 24 hours postoperatively, and post-procedure day 1
Time frame: Preoperative, 24 hours postoperatively, and post-procedure day 1
Hospital Anxiety and Depression Scale (HADS) Score Changes
Time frame: Preoperative and post-procedure day 1
Insomnia Severity Index (ISI) Score Changes
Time frame: Preoperative and post-procedure day 1
Neck Disability Index (NDI) Score Changes
Time frame: Preoperative and post-procedure day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lina Yu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Cervical Epidural Injection in people with Cervical Radiculopathy and Cervical Spondylosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Yu, MD (1395803387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving ≥50% Reduction in NRS Pain Score (time frame: Post-procedure Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.