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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Herpes Zoster
• Intervention / Treatment: Procedure: Acupuncture; Drug: Aciclovir; Procedure: Sham

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dexiong Han, PHD; Phone Number: 86+18958077903; Email: 20105015@zcmu.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Third Affiliated hospital of Zhejiang Chinese Medical University
      • Contact: Dexiong Han, PHD; Phone Number: 86+18958077903; Email: 20105015@zcmu.edu.cn
      • Contact: Xiaoqi Ying, master; Phone Number: 86+13858185657; Email: yingxiaoqi2023@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients who meet the diagnostic criteria for acute HZ27 and skin symptom appears less than 7 days;
2. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture group	Procedure: 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; Drug: Aciclovir; 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)
Placebo Comparator: sham acupuncture group	Drug: Aciclovir; 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); Procedure: Sham; non-penetrating placebo acupuncture
Placebo Comparator: Medication-Alone Group	Drug: Aciclovir; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')	week 0, 1, 2, 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain episodes	week0,1,2
Crusting Time	week2
HAMA	week0,1,2
HAMD	week0,1,2
SF-36	week0,1,2
ESR	week0,1,2
CRP	week0,1,2
TNF-α	week0,1,2
IL-10	week0,1,2
SP	week0,1,2
NPY	week0,1,2
PHN incidence	week13

Collaborators and Investigators

• Sponsor: Dexiong Han
• Collaborators: Changxing County Hospital of Traditional Chinese Medicine; The Third People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Complementary Therapies; Guanine; Hypoxanthines; Purinones; Purines; Acyclovir; salicylhydroxamic acid; Acupuncture Therapy
• Other Study ID Numbers: ZSLL-KY-2025-052-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No