Electroacupuncture for PHN: Efficacy and Biomarker Evaluation in a Multicenter, Randomized, Sham-Controlled Trial Protocol

Electroacupuncture for PHN: Efficacy and Biomarker Evaluation in a Multicenter, Randomized, Sham-Controlled Trial Protocol

The investigators are conducting a clinical study with the following objectives: to evaluate the clinical efficacy of electroacupuncture combined with pregabalin in treating Postherpetic Neuralgia(PHN); to investigate the correlation between serum biomarker levels and pain symptoms;and to determine whether serum biomarkers can serve as prognostic indicators for PHN.

This study utilizes a randomized controlled trial design with assessor blinding. A total of 207 eligible PHN patients were randomly assigned to three groups in a 1:1:1 ratio: the electroacupuncture group, the pharmacotherapy group, and the sham acupuncture group. Comparative analyses of pain intensity and serum biomarker concentrations were conducted across these groups.

For the assessment of clinical outcomes, the investigators employed the following measures: the Numerical Rating Scale(NRS), the Hamilton Anxiety Scale(HAMA), the Hamilton Depression Scale(HAMD), the 36-Item Short Form Health Survey(SF-36), serum levels of substance P(SP)and Neuropeptide Y(NPY), and inflammatory markers(IL-10,TNF-α). These assessments were performed at baseline and at the end of weeks 1, 2, 3, and 4 of treatment.

The investigators anticipate that this clinical trial will enhance our understanding of the therapeutic efficacy and underlying mechanisms of acupuncture in managing PHN. It aims to elucidate the relationship between serum biomarkers and the clinical manifestations of PHN, as well as to explore their potential prognostic value in disease outcomes.

Inclusion Criteria:

• Meet the diagnostic criteria for PHN;
• Age between 20 and 80 years old;
• Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

• Pregnant or lactating women;
• Presence of severe liver or kidney dysfunction, malignant tumors, or other serious diseases;
• Presence of hematologic diseases or coagulation disorders;
• Presence of mental illness or other cognitive impairments, unable to understand or unwilling to cooperate with the study requirements.