Research on the Therapeutic Effect of Electroacupuncture on Acute Herpes Zoster-Associated Pain and Its Anti-inflammatory Injury Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Aged between 20 and 80 years;
- •Patients voluntarily participate in the trial and are willing to sign the informed consent.
排除标准
- •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.
研究组 & 干预措施
Electroacupuncture group
干预措施: Valacyclovir, pregabalin and mecobalamin (Drug)
sham acupuncture group
干预措施: Valacyclovir, pregabalin and mecobalamin (Drug)
Medication-Alone Group
干预措施: Valacyclovir, pregabalin and mecobalamin (Drug)
Electroacupuncture group
干预措施: Acupuncture (Procedure)
sham acupuncture group
干预措施: Sham (Procedure)
研究者
Dexiong Han
Chief TCM Physician
Zhejiang Chinese Medical University