Health TrialsbyHealthPanel

Efficacy of Electroacupuncture for Acute Herpes Zoster-Associated Pain and Biomarker Evaluation

ConditionAcute Herpes Zoster
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorDexiong Han

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Procedure/Surgery

    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

  • Sham

    Procedure/Surgery

    non-penetrating placebo acupuncture

  • Valacyclovir, pregabalin and mecobalamin

    Drug

    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, 0.5 mg, three times daily throughout the trial)

Treatment groups

228 Participants
are divided into 3 treatment groups
Group A: Electroacupuncture groupExperimental treatment 2 interventions
Group B: sham acupuncture groupPlacebo comparator 2 interventions
Group C: Medication-Alone GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numerical Rating Scale

an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')

Time frame
week 0, 1, 2, 13

Secondary outcomes

1

Pain episodes

Time frame
week0,1,2
2

Crusting Time

Time frame
week2
3

HAMA

Time frame
week0,1,2
4

HAMD

Time frame
week0,1,2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dexiong Han

Lead sponsor

Zhejiang Chinese Medical University

Sponsor institution

The Third People's Hospital of Hangzhou

Collaborator

Changxing County Hospital of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov
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