RecruitingNot ApplicableNCT07515885

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

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


Sponsor

Dexiong Han

Enrollment

228 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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;
  • \. 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.

Exclusion Criteria9

  • 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.

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Interventions

PROCEDUREAcupuncture

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

PROCEDURESham

non-penetrating placebo acupuncture

DRUGAciclovir

aciclovir will be administered for antiviral treatment (oral, 800 mg, 5 times daily for 7 days), and pregabalin for pain control (oral, 75 mg, twice daily throughout the trial)


Locations(1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

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NCT07515885