Status:
RECRUITING
High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia
Lead Sponsor:
Shirong Tan
Conditions:
Herpes Zoster Pain
Neuralgia, Postherpetic
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
Research Objectives Background and Significance: Zoster-associated neuralgia (ZAN) refers to neuropathic pain experienced by herpes zoster (HZ) patients before, during, and after rash resolution, char...
Eligibility Criteria
Inclusion
- Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:
- Voluntarily provided written informed consent.
- Inadequate response to pharmacological or other non-surgical therapies OR intolerable drug-related adverse effects.
- Herpes zoster (HZ) lesions involving cranial/cervicocephalic, cervical, thoracic, or lumbar dermatomes.
- Moderate-to-severe pain intensity, defined as a Numerical Rating Scale (NRS) score ≥4 at baseline.
- Aged between 40 and 85 years.
- Body weight: Male ≥50 kg; female ≥45 kg.
Exclusion
- Severe cardiovascular diseases or life-threatening arrhythmias (e.g., heart failure, third-degree atrioventricular block without pacemaker implantation).
- Contraindications to minimally invasive interventions (e.g., coagulation disorders, active infections).
- Allergy to local anesthetics or lipid emulsions; Severe dysfunction of vital organs (cardiac, pulmonary, hepatic, or renal) rendering the patient unfit for the procedure.
- Severe endocrine disorders or long-term use of corticosteroids/immunosuppressive agents.
- Cognitive impairment or inability to cooperate with treatment protocols.
- Prior history of neuromodulation therapies (e.g., spinal cord stimulation or pulsed radiofrequency (PRF) treatment).
Key Trial Info
Start Date :
December 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06959147
Start Date
December 17 2024
End Date
May 31 2026
Last Update
May 6 2025
Active Locations (1)
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1
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000