Electroacupuncture Regulation of Immune Cells in Herpes Zoster
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-70
SponsorFirst People's Hospital of Hangzhou
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Drug
Drug1\) 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.
Electroacupuncture
Procedure/SurgeryElectroacupuncture 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.
Treatment groups
8 Participants
are divided into 2 treatment groupsGroup A: Drug groupActive comparator 1 intervention
Group B: Drugs combined with electroacupuncture groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Peripheral blood immune cell levels
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.
Time frame
Before (Day 0), during (Day 4) and after (Day 7) treatment.Secondary outcomes
1
Visual Analogue Scale
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.
Time frame
Before treatment (Day 0) and after each treatment (Day 1- Day 7).2
Douleur Neuropathique 4 questions
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.
Time frame
Before treatment (Day 0) and after each treatment (Day 1- Day 7).3
Lesion Regression Time
The time for blister cessation, crusting, and scab shedding is recorded.
Time frame
Before treatment (Day 0) and after each treatment (Day 1- Day 7).4
Occurrence of adverse reactions
Record the occurrence of adverse reactions.
Time frame
During the intervention.Sponsors and contacts
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Source ClinicalTrials.gov