Меню
Идёт набор NCT06959147

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

Фаза IV С лечением Herpes Zoster Pain Neuralgia, Postherpetic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group, High-Voltage Long-Duration Pulsed Radiofrequency.
Кому может быть актуально
Состояния в реестре: Herpes Zoster Pain, Neuralgia, Postherpetic. Базовые параметры: 40 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Препарат High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group
    High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block
  • Другое High-Voltage Long-Duration Pulsed Radiofrequency
    High-Voltage Long-Duration Pulsed Radiofrequency

Первичные конечные точки

  • NRS [Срок оценки: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions]
Вторичные конечные точки (5)
  • The Zoster Brief Pain Inventory [Срок оценки: Baseline and on days 7, 30, 90 ,180 post-interventions]
  • Pittsburgh Sleep Quality Index Scale [Срок оценки: Baseline and on days 7, 30, 90 ,180 post-interventions]
  • Use of analgesics (tramadol, gabapentin, or pregabalin) [Срок оценки: Baseline and on days 7, 30, 90,180 post-interventions]
  • Adverse event rate [Срок оценки: Day 1 post-interventions]
  • Expression levels of interleukin-6 (IL-6) [Срок оценки: Baseline and day 1 post-interventions]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Affiliated Hospital of Zunyi Medical University — Zunyi

Идентификаторы

NCT: NCT06959147 · KLLY-2024-236

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗