Establishment of a Prediction Model for Postherpetic Neuralgia

NCT07271784 | Completed

• 1 other identifier: [2023B] IIT.No.0673
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Pain; Biomarkers / Blood

Keywords

Postherpetic neuralgia; biomarker

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Pain; Neuralgia; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Pain Department

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: December 9, 2025
• Study Start: September 1, 2023
• Primary Completion: May 24, 2024
• Study Completion: June 24, 2024
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)