Biomarker Study in Patients With Herpes Zoster

Inflammatory Cytokine and Neuropeptide Study in Patients With Herpes Zoster

Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with herpes zoster.

Study Overview

• Status: Completed
• Conditions: Herper Zoster
• Intervention / Treatment: Procedure: Herpes zoszter (acute)with inter vention

Detailed Description

Sudden and electrick shooting sensation of face is an important clinical feature of herpes zoster. The severe and excruciating nature of pain intensity associated with herpes zoster can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of herpes zoster still remains unclear.

Recentrly, there have been a few studies suggesting biomarker levels in the blood and CSF level, however, further study is required to elucidate the action mechanism.

Up to 90% of patients can achieve pain reduction using medical therapy alone. However, 10% -15% of herpes zoster cases demonstrate a minimal response to medication with various side effects. Radiofrequency thermocoagulation (RFT) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. Recent study revealed that RFT of the trigeminal ganglion resulted in Barrow Neurological Institute (BNI) pain scale I or II in 71.7% of patients, with a median time to recurrence of 36 months.

Although patients experience significant pain relief after RFT, it is uncertain whether inflammatory cytokine and neurocytokine (CGRP, substance P, VIP) are reduced.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Daegu, South Korea, 42601
    • Hong Ji Hee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients with NRS more than 4
• patients who failed medical treatment
• patients showing severe adverse reaction with medication

Exclusion Criteria:

• Patients showing allergic reaction to local anesthetics
• Patients with coagulation abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: herpes zoster (acute) patients with intervention; Patients with herpes zoster receiving 2 times of nerve block	Procedure: Herpes zoszter (acute)with inter vention; nerve block
Experimental: patients with chronic herpes zoster receiving 2 times of nerve block; Patients with herpes zoster receiving 2 times of nerve block	Procedure: Herpes zoszter (acute)with inter vention; nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum level of inflammatory cytokine changes during 3 time period	inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome	Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
serum level of neurotransmitter changes during 3 time period	neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome	Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of numerical rating scale changes during 3 time period	numerical rating scale changes during 3 time period	Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 21, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cytokine; herpes zoster; neurotransmitter
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster
• Other Study ID Numbers: 2022-09-016

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