A Phase 4 interventional study of High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group and High-Voltage Long-Duration Pulsed Radiofrequency in Herpes Zoster Pain and Neuralgia, Postherpetic, sponsored by Shirong Tan. Recruiting at 1 site in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Shirong Tan · Phase 4, Interventional, and Treatment
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.
Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:
Exclusion Criteria:
After high-voltage pulsed radiofrequency (HL-PRF) treatment targeting the dorsal root ganglion (DRG), a local anesthetic (Liposomal bupivacaine) was administered via subcutaneous injection at the painful lesion site 2 hours post-procedure.
Drug: High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group
Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG).
Other: High-Voltage Long-Duration Pulsed Radiofrequency
High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block
High-Voltage Long-Duration Pulsed Radiofrequency
NRS
0 indicates no pain,1-3 indicate mild pain,4-6 indicate moderate pain, 7-10indicate severe pain.
Time frame: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions
The Zoster Brief Pain Inventory
The instrument comprises two validated domains: pain intensity quantification and pain-related functional interference assessment. With higher composite scores (range: 0-20) indicating greater multidimensional health impairment.
Time frame: Baseline and on days 7, 30, 90 ,180 post-interventions
Pittsburgh Sleep Quality Index Scale
Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 20, with lower scores indicating better sleep quality, thereby assessing overall sleep status.
Time frame: Baseline and on days 7, 30, 90 ,180 post-interventions
Use of analgesics (tramadol, gabapentin, or pregabalin)
Analgesic consumption metrics, including frequency of use and morphine equivalent daily dose (MEDD), were recorded to evaluate longitudinal changes in pain intensity."
Time frame: Baseline and on days 7, 30, 90,180 post-interventions
Adverse event rate
Adverse events include: Surgery-related complications (e.g., pneumothorax, hematoma, wound infection); Complications associated with bupivacaine liposome subcutaneous block, such as: Cardiac adverse events (e.g., arrhythmias, hypotension); Local tissue toxicity (e.g., myonecrosis, neuropathy).
Time frame: Day 1 post-interventions
Expression levels of interleukin-6 (IL-6)
Interleukin-6 (IL-6) levels are positively correlated with the severity of postherpetic neuralgia (PHN) pain.
Time frame: Baseline and day 1 post-interventions
Plan to share: Yes — Via email (15085046515@163.com)
Supporting information: Study protocol, Sap, Icf, Csr
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