Efficacy of Electroacupuncture for Acute Herpes Zoster-Associated Pain and Biomarker Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Sham, Valacyclovir, pregabalin and mecobalamin.
- Who it may be relevant to
- Registry conditions: Acute Herpes Zoster. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Research on the Therapeutic Effect of Electroacupuncture on Acute Herpes Zoster-Associated Pain and Its Anti-inflammatory Injury Mechanism
Overview
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.
Interventions
- Procedure Acupuncture
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 - Procedure Sham
non-penetrating placebo acupuncture - Drug Valacyclovir, pregabalin and mecobalamin
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
Primary outcome measures
- Numerical Rating Scale [Time frame: week 0, 1, 2, 13]
Secondary outcome measures (12)
- Pain episodes [Time frame: week0,1,2]
- Crusting Time [Time frame: week2]
- HAMA [Time frame: week0,1,2]
- HAMD [Time frame: week0,1,2]
- SF-36 [Time frame: week0,1,2]
- ESR [Time frame: week0,1,2]
- CRP [Time frame: week0,1,2]
- TNF-α [Time frame: week0,1,2]
- IL-10 [Time frame: week0,1,2]
- SP [Time frame: week0,1,2]
- NPY [Time frame: week0,1,2]
- PHN incidence [Time frame: week13]
Eligibility criteria
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;
2\. 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
Identifiers
NCT: NCT07515885 · ZSLL-KY-2025-052-01