Skip to main content
OpenTrials
Completed

NCT Number: NCT07271784

Establishment of a Prediction Model for Postherpetic Neuralgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years Location of pain consistent with the HZ region and pain originating from herpes zoster (HZ)

Exclusion criteria

Mental disorders, cognitive deficits, or coexisting painful diseases Severe cardio-cerebrovascular disease, hepatorenal insufficiency, infectious disease Cancer with a recurrence-free survival of less than one year Hematological disorders such as lymphoma or conditions such as acquired immune deficiency syndrome (AIDS) Psychiatric disorders; alcohol addiction; opioid abuse Previous treatment with interventional neurodestructive therapies or spinal cord stimulation (SCS)

Treatment and study plan

Primary outcomes

  1. Occurrence of Postherpetic Neuralgia (PHN) as Assessed by the Numerical Rating Scale (NRS) at 3 months after herpes zoster onset.

    Time frame: At the 3-month timepoint after herpes zoster onset.

    HN is defined as pain that persists in the area affected by the herpes zoster rash after the acute rash has healed, and that is present at 3 months after rash onset. The presence and intensity of this pain will be assessed using the Numerical Rating Scale (NRS), with an NRS score of ≥ 1 used as the threshold to define the presence of clinically pain. Study participants will be categorized based on the presence of PHN at the 3-month timepoint according to this definition.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.