The Regulatory Mechanisms of Electroacupuncture Intervention on Immune Cells in Herpes Zoster
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Peripheral blood immune cell levels
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
Drug group
Control group
Intervention: Drug (Drug)
Drugs combined with electroacupuncture group
Observation group
Intervention: Drug (Drug)
Drugs combined with electroacupuncture group
Observation group
Intervention: Electroacupuncture (Procedure)
Outcomes
Primary Outcomes
Peripheral blood immune cell levels
Time Frame: 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 Outcomes
- Visual Analogue Scale(Before treatment (Day 0) and after each treatment (Day 1- Day 7).)
- Douleur Neuropathique 4 questions(Before treatment (Day 0) and after each treatment (Day 1- Day 7).)
- Lesion Regression Time(Before treatment (Day 0) and after each treatment (Day 1- Day 7).)
- Occurrence of adverse reactions(During the intervention.)
Investigators
Yan Shi
Director
First People's Hospital of Hangzhou