Electroacupuncture Regulation of Immune Cells in Herpes Zoster

Not Applicable

Recruiting

• Conditions: Herpes Zoster; Electroacupuncture; Immune
• Interventions: Drug: Drug; Procedure: Electroacupuncture

• Registration Number: NCT06643247
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-12
• Study First Posted: 2024-10-16
• Status Verified: 2024-11
• Study Start: 2024-11-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug group	Drug	Control group
Drugs combined with electroacupuncture group	Drug	Observation group
Drugs combined with electroacupuncture group	Electroacupuncture	Observation group

Primary Outcome Measures

Name	Time	Method
Peripheral blood immune cell levels	Before (Day 0), during (Day 4) and after (Day 7) treatment.	1. 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 Outcome Measures

Name	Time	Method
Visual Analogue Scale	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.
Douleur Neuropathique 4 questions	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.
Lesion Regression Time	Before treatment (Day 0) and after each treatment (Day 1- Day 7).	The time for blister cessation, crusting, and scab shedding is recorded.
Occurrence of adverse reactions	During the intervention.	Record the occurrence of adverse reactions.

Trial Locations

Locations (1)

The Affiliated Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China