Establishment of a Prediction Model for Postherpetic Neuralgia

Zhejiang University

Status: Completed

Conditions: Neuropathic Pain; Biomarkers / Blood; Pain

Study type: Observational

Funder types: Other

Identifiers

NCT07271784

[2023B] IIT.No.0673

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

151 participants in 2 patient groups

PHN Group

Description:

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

Description:

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.