Efficacy of Electroacupuncture for Acute Herpes Zoster-Associated Pain and Biomarker Evaluation

Официальное название

Research on the Therapeutic Effect of Electroacupuncture on Acute Herpes Zoster-Associated Pain and Its Anti-inflammatory Injury Mechanism

Обзор

Background: Herpes zoster (HZ) is an acute dermatological condition caused by the varicella-zoster virus. Its onset is characterized by severe pain, imposing significant physical and psychological burdens on patients. Acupuncture offers distinct advantages in treating acute herpes zoster and associated pain. However, the therapeutic efficacy of electroacupuncture for acute herpes zoster, its potential to reduce PHN incidence, and the role of biomarkers in predicting PHN incidence require further clinical validation. Methods: A total of 228 patients with acute herpes zoster will be recruited from 3 hospitals and randomly assigned to EA group or medication-alone group or sham acupuncture group in a 1:1:1 ratio, utilizing multicenter stratified block randomization. The trial will involve a 2 week treatment period, and a 3-month follow-up period. All variables will be evaluated at week 0, week 1, week 2, and on the 90th day after rash onset. All participants will continue antiviral medication treatment. Primary outcome is Numerical Rating Scale; secondary outcomes include herpes lesion crusting time, pain episodes within a 24-hour period, Hamilton Anxiety Scale, Hamilton Depression Scale, 36-Item Short Form Health Survey, changes of biomarkers (Erythrocyte sedimentation rate, C-reactive protein, Tumor Necrosis Factor-α, Interleukin-10, Substance P and neuropeptide Y) and PHN incidence rate. All adverse effects will be assessed during the trial. Conclusion: This study will elucidate the efficacy of electroacupuncture in treating acute herpes zoster, whether electroacupuncture can reduce the incidence of PHN, and the role of biomarkers in predicting the incidence of PHN.

Вмешательства

• Процедура Acupuncture
  EA will be applied at Ashi points (sites of severe pain in herpetic lesions) and Jiaji points (EX-B2) on the affected side.All participants will undergo a 2-week treatment. Acupuncture will be performed thrice a week.A dense-disperse wave (2/100 Hz) will be used
• Процедура Sham
  non-penetrating placebo acupuncture
• Препарат Valacyclovir, pregabalin and mecobalamin
  Antiviral therapy: The main treatment is with valacyclovir (oral, 1000 mg, three times daily, for 7 days). In patients with non-severe hepatic or renal impairment, or other conditions that require dose adjustment, the antiviral regimen (dose or drug choice) should be modified according to the Chinese Consensus on the Diagnosis and Management of Herpes Zoster (2022). Antineuralgic therapy: Pregabalin (oral, 75 mg, two times daily throughout the trial). Neurotrophic therapy: Mecobalamin (oral, 0

Первичные конечные точки

• Numerical Rating Scale [Срок оценки: week 0, 1, 2, 13]

Вторичные конечные точки (12)

• Pain episodes [Срок оценки: week0,1,2]
• Crusting Time [Срок оценки: week2]
• HAMA [Срок оценки: week0,1,2]
• HAMD [Срок оценки: week0,1,2]
• SF-36 [Срок оценки: week0,1,2]
• ESR [Срок оценки: week0,1,2]
• CRP [Срок оценки: week0,1,2]
• TNF-α [Срок оценки: week0,1,2]
• IL-10 [Срок оценки: week0,1,2]
• SP [Срок оценки: week0,1,2]
• NPY [Срок оценки: week0,1,2]
• PHN incidence [Срок оценки: week13]

Критерии участия

Критерии включения

• Patients who meet the diagnostic criteria for acute HZ27 and skin symptom appears less than 7 days;
• Only have lesions in the trunk and limbs;

2\. Patients with a Numerical Rating Scale (NRS) score ≥ 4; 3. Aged between 20 and 80 years; 4. Patients voluntarily participate in the trial and are willing to sign the informed consent.

Критерии исключения

• Special types of HZ that occur in head, eyes, viscera, etc. or those combined with other skin diseases;
• Has received relevant treatment and it may affect the observation indicators;
• Pregnant and lactating women;
• Patients who are allergic to iodophor or other topical disinfectants, or a history of sudden, potentially life-threatening systemic allergic reactions;
• Those who are afraid of acupuncture or have metal implants and are not suitable for EA treatment;
• Those with contraindications to pregabalin such as congestive heart disease and heart failure;
• Patients with severe primary diseases such as liver, kidney, cardiovascular and cerebrovascular, metabolic, autoimmune system diseases, malignant tumors, etc., and those with mental illness;
• Patients who have hematologic diseases or coagulation disorders;
• Patients who are currently participating in other clinical studies.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

NCT: NCT07515885 · ZSLL-KY-2025-052-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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