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NCT Number: NCT06643247

Electroacupuncture Regulation of Immune Cells in Herpes Zoster

Herpes Zoster (HZ), caused by the Varicella-Zoster Virus (VZV), is a common infection characterized by localized pain and blistering, with higher incidence in females. HZ affects patients' physical health, mental well-being, and quality of life. The immune system is critical in HZ pathogenesis. Studies show acupuncture relieves pain, modulates immunity, and may lower postherpetic neuralgia (PHN) risk. However, evidence is limited on whether electroacupuncture (EA) alleviates HZ by modulating immune cells. Using mass cytometry (CyTOF), this study will analyze peripheral immune cell changes pre- and post-EA to explore its regulatory effects on HZ immunity. This study will recruit HZ patients and healthy controls (HC), dividing patients into medication-only and medication+EA groups to assess EA's potential immunomodulatory effects in HZ treatment.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Electroacupuncture Herpesviridae Infections Immune Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310053, China

Location status: Recruiting

Location contact

Yan Shi

CONTACT

[email protected]

13867439433

About this study

The study will enroll 8 HZ patients who meet the inclusion criteria and 3 age- and gender-matched healthy controls (HC). HZ patients will be randomly assigned in a 1:1 ratio to a medication-only group or a medication plus electroacupuncture group. All participants will receive Valacyclovir Hydrochloride tablets and Mecobalamin tablets. HZ-related immune cells in peripheral blood will be analyzed using CyTOF before treatment (day 0), during treatment (day 4), and after treatment (day 7). Pain intensity and characteristics will be assessed using the Visual Analogue Scale (VAS) and the Douleur Neuropathique 4 (DN4) questionnaire. Lesion healing (time to vesicle cessation, crusting, and scab detachment) and adverse events will also be recorded to evaluate lesion regression in HZ patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for HZ:

  • Meets HZ diagnostic criteria;
  • Female, aged between 50 and 70 years;
  • Disease duration ≤7 days, with no prior antiviral, analgesic, or other treatments;
  • Herpetic lesions limited to the trunk, within 1 to 3 dermatomes;
  • Willing to participate in the trial and has signed the informed consent form.

Inclusion criteria

for HC:

  • No history of HZ or major cardiovascular, respiratory, digestive, urinary, hematologic, endocrine, or neurological diseases;
  • Age-matched female HC volunteers for the HZ group;
  • Clear consciousness and ability to communicate normally;
  • Fully understands the study protocol, demonstrates good compliance, and is willing to cooperate with the study;
  • Has signed a written informed consent form.

Exclusion criteria

  • Special types of herpes zoster, including ophthalmic, otic, visceral, meningeal herpes zoster, and zoster sine herpete;
  • Women who are planning to conceive, pregnant, or breastfeeding;
  • Patients with severe primary diseases of the circulatory, respiratory, or endocrine systems, or systemic failure;
  • Patients with bleeding tendencies;
  • Use of corticosteroids or immunosuppressants within the past month.

Treatment and study plan

Drug

Drug
  • Valacyclovir Hydrochloride tablets, 0.3 g per dose, twice daily; 2) Mecobalamin tablets, 0.5 mg, three times daily. Taken continuously for 7 days.The affected skin is kept clean and protected to maintain lesion integrity.

Other names: Medication

electroacupuncture

Procedure

Electroacupuncture Treatment: Needling acupoints include the Jiaji points corresponding to the spinal nerve segment of the affected area, Ashi acupoints along the affected zone, and bilateral Hegu and Waiguan points. Electroacupuncture will be performed once daily for 30 minutes per session, with a total of 7 consecutive sessions. The Jiaji and Ashi acupoints will be connected to an electroacupuncture device, set to disperse-dense wave stimulation at a frequency of 2/100 Hz, with current intensity adjusted to the patient's tolerance level.

Other names: EA

Primary outcomes

  1. Peripheral blood immune cell levels

    Time frame: Before (Day 0), during (Day 4) and after (Day 7) treatment.

    • Custom Detection Panel: A 42-color detection panel is specifically designed according to the study objectives and target cell subpopulations. 2. Sample Collection and Processing: Peripheral blood (5 ml) is collected from patients into EDTA purple-top anticoagulant tubes, stored/transported at 4°C, and processed within 48 hours using Ficoll to isolate the PBMC layer, yielding a single-cell suspension of PBMCs. PBMCs can be cryopreserved for batch analysis or processed fresh for immediate analysis. 3. Staining and Analysis: Samples are stained and analyzed over two days. Surface antibodies are stained on the first day, followed by membrane permeabilization and intracellular antibody staining on the second day, before proceeding with CyTOF analysis.

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).

    The Visual Analogue Scale (VAS) is used to assess pain and is widely applied in clinical practice in China. The basic method involves a 10 cm sliding ruler with one side marked with 10 increments. One end is labeled "0," indicating no pain, and the other end is labeled "10," representing the most intense, unbearable pain.

  2. Douleur Neuropathique 4 questions

    Time frame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).

    The DN4 questionnaire consists of 10 items, with 7 items describing symptoms and 3 items related to clinical examination. Symptom descriptions include burning pain, cold pain, electric shock pain, tingling, pins and needles, numbness, and itching. Clinical examination includes decreased touch sensation, decreased pinprick sensation, and whether brushing in the painful area triggers or increases pain. Each item has "Yes" and "No" options, with "Yes" scored as 1 and "No" scored as 0, for a total score of 10. A score of ≥4 indicates a diagnosis of neuropathic pain.

  3. Lesion Regression Time

    Time frame: Before treatment (Day 0) and after each treatment (Day 1- Day 7).

    The time for blister cessation, crusting, and scab shedding is recorded.

  4. Occurrence of adverse reactions

    Time frame: During the intervention.

    Record the occurrence of adverse reactions.

Study contacts

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

Mingqi Tu

CONTACT

[email protected]

15700067213

Yan Shi

CONTACT

[email protected]

13867439433

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

The Regulatory Mechanisms of Electroacupuncture Intervention on Immune Cells in Herpes Zoster

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
Feb 3, 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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