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Completed

NCT Number: NCT05685797

Biomarker 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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong ji HEE

Daegu, 42601, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herpes zoszter (acute)with inter vention

Procedure

nerve block

Primary outcomes

  1. serum level of inflammatory cytokine changes during 3 time period

    Time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

    inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome

  2. serum level of neurotransmitter changes during 3 time period

    Time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

    neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome

Secondary outcomes

  1. Changes of numerical rating scale changes during 3 time period

    Time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

    numerical rating scale changes during 3 time period

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Inflammatory Cytokine and Neuropeptide Study in Patients With Herpes Zoster

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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