NCT07271784

Establishment of a Prediction Model for Postherpetic Neuralgia

Establishment of a Prediction Model for Postherpetic Neuralgia Based on Immune Cell Typing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 151 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective cohort study enrolled 300 herpes zoster (HZ) patients at varying disease stages (1 week to 3 months post-onset) to investigate predictors of postherpetic neuralgia (PHN). Comprehensive baseline data were collected, including demographic characteristics (age, sex, body mass index \[BMI\]), clinical comorbidities (hypertension, diabetes mellitus), disease-specific parameters (duration of zoster-associated pain \[ZAP\], dermatomal distribution, pregabalin dosage equivalents), and psychometric assessments using validated scales (Numerical Rating Scale \[NRS\], age-adjusted Charlson Comorbidity Index \[aCCI\], Generalized Anxiety Disorder-7 \[GAD-7\], Patient Health Questionnaire-9 \[PHQ-9\], and Insomnia Severity Index \[ISI\]). Laboratory evaluations encompassed routine hematological tests (complete blood count \[CBC\], hepatic/renal function), metabolic profiling (triglycerides \[TG\], total cholesterol \[TC\], lipoprotein subfractions), inflammatory markers (erythrocyte sedimentation rate \[ESR\], comprehensive cytokine panel including interleukins \[IL\] and interferons \[IFN\]), and detailed immunophenotyping via multicolor flow cytometry of peripheral blood lymphocytes. After a 3-month follow-up, patients were to be stratified into PHN and non-PHN groups based on pain persistence. The use of least absolute shrinkage and selection operator (LASSO) regression analysis was planned to identify significant predictive factors and develop a multivariate model, with the aim of establishing a precision medicine framework for early PHN risk stratification through integrated analysis of clinical and immunological parameters.

Conditions

• Pain
• Neuropathic Pain
• Biomarkers / Blood

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-05-24
• Completion: 2024-06-24
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: China