Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06959147

High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Herpes Zoster Pain Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location status: Recruiting

Location contact

Shirong Tan

CONTACT

[email protected]

+8615085046515

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group

Drug

High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block

High-Voltage Long-Duration Pulsed Radiofrequency

Other

High-Voltage Long-Duration Pulsed Radiofrequency

Primary outcomes

  1. NRS

    Time frame: 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 outcomes

  1. The Zoster Brief Pain Inventory

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index Scale

    Time frame: 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.

  3. Use of analgesics (tramadol, gabapentin, or pregabalin)

    Time frame: 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."

  4. Adverse event rate

    Time frame: 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).

  5. Expression levels of interleukin-6 (IL-6)

    Time frame: Baseline and day 1 post-interventions

    Interleukin-6 (IL-6) levels are positively correlated with the severity of postherpetic neuralgia (PHN) pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirong Tan

CONTACT

[email protected]

+8615085046515

Sponsors and collaborators

Lead sponsor

Shirong Tan

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.