An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Cervical Epidural Injection in Cervical Radiculopathy, Cervical Spondylosis and Radicular Pain, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
Among 15 studies in Radiculopathy with a site in China — 5 open to participants now, 5 under way, none of them phase 3. Radiculopathy · China.
Among the 15 studies in Radiculopathy with a site in China, this one is the 9th largest by planned enrollment of the 12 interventional ones, is the only one that started in 2026, is one of 9 with no phase, and was the 14th registered.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →5 of the 15 studies in Radiculopathy with a site in China are open now, in 1 country. Each count lists the studies.
Of the 80 Radiculopathy studies recruiting now, 23 (29%) set no upper age limit and 49 (61%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2026.
Median enrollment 145 across the 12 interventional studies, 500 across the 3 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
None of the 15 has an industry lead sponsor. The 10 most frequent:
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Second Affiliated Hospital, School of Medicine, Zhejiang University has 1 study filed under Radiculopathy — fewer than ten, so there is no comparison to draw.
2 of the studies in Radiculopathy with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07557823Second Affiliated Hospital, School of Medicine, Zhejiang UniversityTranscutaneous Auricular Vagus Nerve Stimulation Combined With Cervical Epidural Injection for Cervical Radiculopathy | 2026-12-30 |
| NCT06591442Wuhan Union Hospital, ChinaScreening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient | 2027-09-03 |
Among the 15 studies in Radiculopathy with a site in China, from their registry updates:
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
Standard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.
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.
Time frame: Post-procedure Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative and post-procedure day 1
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.
Of 203 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 8 months is below that.
Counting every sponsor, half of 215 studies reached it within 12 months; a quarter within 5 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →