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Transcutaneous auricular vagus nerve stimulation (taVNS) combined with neuromodulation via radiofrequency for postherpetic neuralgia: a single-center, prospective, randomized controlled study

Transcutaneous auricular vagus nerve stimulation (taVNS) combined with neuromodulation via radiofrequency for postherpetic neuralgia: a single-center, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122258
Enrollment
Unknown
Registered
2026-04-10
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes zoster (HZ)

Interventions

experimental group:Receive taVNS treatment
control group:Received treatment with sham tAVNS

Sponsors

Huzhou Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 80 years old (inclusive), no gender restriction. 2. Clinical diagnosis: Consistent with the diagnostic criteria for postherpetic neuralgia (PHN), which refers to the persistent pain in the affected nerve distribution area for more than 3 months after the healing of acute herpes zoster rash. 3. Pain level: The average visual analog scale (VAS) score for pain intensity within 24 hours before enrollment is >= 4. 4. Target nerve: A single or multiple affected somatic nerves or posterior branches of spinal nerves with a clear and identifiable distribution area that corresponds to the painful region, suitable for radiofrequency treatment. 5. The patient had previously received at least 4 weeks of standard drug therapy (such as pregabalin, gabapentin, tricyclic antidepressants, etc.), but the efficacy was poor (VAS score reduction did not reach 50%), the patient could not tolerate the side effects, or the pain recurred, and/or the patient voluntarily chose interventional therapy and agreed to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Other diseases that may lead to chronic pain, such as severe lumbar disc herniation, spinal stenosis, complex regional pain syndrome (CRPS), fibromyalgia, and cancer pain, were also included, and the researchers judged that these diseases would interfere with the evaluation of the study's effectiveness. 2. Specific contraindications for taVNS: individuals with cardiac pacemakers, implantable cardioverter defibrillators (ICDs), or other internal electronic/metallic implants. Individuals with a history of vagotomy or carotid sinus hypersensitivity. Individuals with uncontrolled arrhythmias, symptomatic bradycardia or conduction block, unstable angina, or recent (within 6 months) myocardial infarction. Individuals with local skin lesions, infections, dermatitis, or eczema at the stimulation site (ear and surrounding area). 3. Specific contraindications for radiofrequency ablation: presence of severe coagulopathy (INR > 1.5 or platelet count 2 times the upper limit of normal, eGFR < 60 mL/min/1.73m²). Previously diagnosed with epilepsy. 5. Diagnosed with schizophrenia, severe depression, mania, dementia, or other severe mental disorders, unable to cooperate in completing research and questionnaire assessments. 6. Concomitant medication and study conflicts: Recent (within 1 month) use of medications that may significantly affect pain assessment, such as systemic corticosteroids (except for short-term topical use) and opioids (may be included as appropriate for patients who have been using weak opioids at a stable dose for more than 4 weeks). 7. Participation in other studies: Currently participating in or having participated in other interventional clinical trials within 3 months prior to enrollment. 8. Women who are pregnant or breastfeeding, or women of childbearing age who plan to become pregnant during the study period and are unwilling to adopt effective contraceptive measures. 9. The researcher judges that the patient may not be able to comply with the research protocol (such as long-term alcohol abuse, history of drug abuse, inability to communicate, and no fixed residence, which may lead to loss to follow-up).

Design outcomes

Primary

MeasureTime frame
Change value of VAS score relative to baseline;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;SF-36 Quality of Life Survey;

Countries

China

Contacts

Public ContactHu Jiajun

Huzhou Center Hospital

1906234524@qq.com+86 182 6785 1983

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026