Herpes Zoster Pain, Neuralgia, Postherpetic
Conditions
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.
Interventions
DRUGHigh-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group
High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block
High-Voltage Long-Duration Pulsed Radiofrequency
Sponsors
Shirong Tan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS | Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions | 0 indicates no pain,1-3 indicate mild pain,4-6 indicate moderate pain, 7-10indicate severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Zoster Brief Pain Inventory | Baseline and on days 7, 30, 90 ,180 post-interventions | 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. |
| Pittsburgh Sleep Quality Index Scale | Baseline and on days 7, 30, 90 ,180 post-interventions | Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 20, with lower scores indicating better sleep quality, thereby assessing overall sleep status. |
| Use of analgesics (tramadol, gabapentin, or pregabalin) | Baseline and on days 7, 30, 90,180 post-interventions | Analgesic consumption metrics, including frequency of use and morphine equivalent daily dose (MEDD), were recorded to evaluate longitudinal changes in pain intensity. |
| Adverse event rate | Day 1 post-interventions | 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). |
| Expression levels of interleukin-6 (IL-6) | Baseline and day 1 post-interventions | Interleukin-6 (IL-6) levels are positively correlated with the severity of postherpetic neuralgia (PHN) pain. |
Countries
China
Contacts
Primary ContactShirong Tan
Outcome results
None listed