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NCT Number: NCT07515885

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

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.

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Key information

Conditions

Acute Herpes Zoster

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Dexiong Han, PHD

CONTACT

[email protected]

86+18958077903

Xiaoqi Ying, master

CONTACT

[email protected]

86+13858185657

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Acupuncture

Procedure

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

Sham

Procedure

non-penetrating placebo acupuncture

Valacyclovir, pregabalin and mecobalamin

Drug

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, 0.5 mg, three times daily throughout the trial)

Primary outcomes

  1. Numerical Rating Scale

    Time frame: week 0, 1, 2, 13

    an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')

Secondary outcomes

  1. Pain episodes

    Time frame: week0,1,2

  2. Crusting Time

    Time frame: week2

  3. HAMA

    Time frame: week0,1,2

  4. HAMD

    Time frame: week0,1,2

  5. SF-36

    Time frame: week0,1,2

  6. ESR

    Time frame: week0,1,2

  7. CRP

    Time frame: week0,1,2

  8. TNF-α

    Time frame: week0,1,2

  9. IL-10

    Time frame: week0,1,2

  10. SP

    Time frame: week0,1,2

  11. NPY

    Time frame: week0,1,2

  12. PHN incidence

    Time frame: week13

Study contacts

Contact information is provided by the study sponsor or research team.

Dexiong Han, PHD

CONTACT

[email protected]

86+18958077903

Sponsors and collaborators

Lead sponsor

Dexiong Han

Other Gov

Collaborators

  • Changxing County Hospital of Traditional Chinese Medicine
  • The Third People's Hospital of Hangzhou

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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