Skip to content

Establishment of a Prediction Model for Postherpetic Neuralgia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07271784
Enrollment
151
Registered
2025-12-09
Start date
2023-09-01
Completion date
2024-06-24
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers / Blood, Neuropathic Pain, Pain

Keywords

Postherpetic neuralgia, biomarker

Brief 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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026