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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-PRF+LB group | Experimental | 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. |
|
| HL-PRF group | Other | Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group | Drug | High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | 0 indicates no pain,1-3 indicate mild pain,4-6 indicate moderate pain, 7-10indicate severe pain. | Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and on days 7, 30, 90 ,180 post-interventions |
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Inclusion Criteria:
Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirong Tan | Contact | +8615085046515 | 15085046515@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Yuan | Zunyi Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
Via email (15085046515@163.com)
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| High-Voltage Long-Duration Pulsed Radiofrequency | Other | High-Voltage Long-Duration Pulsed Radiofrequency |
|
| 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. |
| 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." | 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). | 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. | Baseline and day 1 post-interventions |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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