NCT06959147 High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia
| NCT ID | NCT06959147 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shirong Tan |
| Condition | Herpes Zoster Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 46 participants in total. It began in 2024-12-17 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, characterized by paroxysmal, lightning-like, or knife-like sensations. Postherpetic neuralgia (PHN), a common type of chronic pain, is often accompanied by physical-psychological impairments, social dysfunction, and anxiety-depression. While high-voltage long-term pulsed radiofrequency (HL-PRF) has become a conventional treatment for ZAN, it is limited by residual postoperative localized pain and suboptimal efficacy for refractory cases. Liposomal bupivacaine (LB), a sustained-release analgesic providing up to 72 hours of pain relief, offers potential for combined subcutaneous injection to enhance symptomatic control. Study Process: This clinical study focuses on evaluating the efficacy of HL-PRF combined with LB subcutaneous injection in treating ZAN. The trial will be conducted from December 16, 2024, to December 14, 2026, with an anticipated enrollment of 92 participants. Patients will be randomized into two groups: HL-PRF group: Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG). HL-PRF+LB group: HL-PRF treatment followed by LB subcutaneous injection at the painful lesion site 2 hours post-procedure. Clinical data will be collected preoperatively, and inflammatory factors will be assessed on the first postoperative day. Follow-up evaluations via telephone will occur at 1 week, 1 month, 3 months, and 6 months postoperatively. By analyzing changes in observed indicators before and after treatment, this study aims to determine the clinical efficacy of combining HL-PRF with LB subcutaneous injection for ZAN.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: * 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).
Contact & Investigator
Jie Yuan
PRINCIPAL INVESTIGATOR
Zunyi Medical College
Frequently Asked Questions
Who can join the NCT06959147 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Herpes Zoster Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06959147 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06959147 currently recruiting?
Yes, NCT06959147 is actively recruiting participants. Contact the research team at 15085046515@163.com for enrollment information.
Where is the NCT06959147 trial being conducted?
This trial is being conducted at Zunyi, China.
Who is sponsoring the NCT06959147 clinical trial?
NCT06959147 is sponsored by Shirong Tan. The principal investigator is Jie Yuan at Zunyi Medical College. The trial plans to enroll 46 participants.