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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorDexiong Han

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Acupuncture
  • Sham
  • Valacyclovir, pregabalin and mecobalamin

Treatment groups

228 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Dexiong Han

Lead sponsor

Zhejiang Chinese Medical University

Sponsor institution

The Third People's Hospital of Hangzhou

Collaborator

Changxing County Hospital of Traditional Chinese Medicine

Collaborator