Establishment of a Prediction Model for Postherpetic Neuralgia

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Neuropathic Pain; Biomarkers / Blood

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subjects included patients with zoster associated pain who meet the inclusion and exclusion criteria for this study.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PHN Group; Patients with herpes zoster were classified into the postherpetic neuralgia (PHN) group if they had a Numerical Rating Scale (NRS) pain score ≥1 at 3 months after disease onset.
non-PHN Group; Patients with herpes zoster were classified into the non postherpetic neuralgia (non-PHN) group if they had a Numerical Rating Scale (NRS) pain score of 0 at 3 months after disease onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Postherpetic Neuralgia (PHN) as Assessed by the Numerical Rating Scale (NRS) at 3 months 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.	At the 3-month timepoint after herpes zoster onset.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: biomarker; Postherpetic neuralgia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: [2023B] IIT.No.0673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No