Acute Herpes Zoster
Conditions
Brief summary
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
PROCEDUREAcupuncture
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
PROCEDURESham
non-penetrating placebo acupuncture
DRUGAciclovir
aciclovir will be administered for antiviral treatment (oral, 800 mg, 5 times daily for 7 days), and pregabalin for pain control (oral, 75 mg, twice daily throughout the trial)
Sponsors
Dexiong Han
The Third People's Hospital of Hangzhou
Changxing County Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who meet the diagnostic criteria for acute HZ27 and skin symptom appears less than 7 days; 2. 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
1. Special types of HZ that occur in head, eyes, viscera, etc. or those combined with other skin diseases; 2. Has received relevant treatment and it may affect the observation indicators; 3. Pregnant and lactating women; 4. Patients who are allergic to iodophor or other topical disinfectants, or a history of sudden, potentially life-threatening systemic allergic reactions; 5. Those who are afraid of acupuncture or have metal implants and are not suitable for EA treatment; 6. Those with contraindications to pregabalin such as congestive heart disease and heart failure; 7. Patients with severe primary diseases such as liver, kidney, cardiovascular and cerebrovascular, metabolic, autoimmune system diseases, malignant tumors, etc., and those with mental illness; 8. Patients who have hematologic diseases or coagulation disorders; 9. Patients who are currently participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | week 0, 1, 2, 13 | an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain') |
Secondary
| Measure | Time frame |
|---|---|
| Pain episodes | week0,1,2 |
| Crusting Time | week2 |
| HAMA | week0,1,2 |
| HAMD | week0,1,2 |
| SF-36 | week0,1,2 |
| ESR | week0,1,2 |
| CRP | week0,1,2 |
| TNF-α | week0,1,2 |
| IL-10 | week0,1,2 |
| SP | week0,1,2 |
| NPY | week0,1,2 |
| PHN incidence | week13 |
Countries
China
Contacts
CONTACTDexiong Han, PHD
Outcome results
None listed