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Clinical Trials/NCT05685797
NCT05685797CompletedNot Applicable

Inflammatory Cytokine and Neuropeptide Study in Patients With Herpes Zoster

Keimyung University Dongsan Medical Center1 site in 1 country30 target enrollmentStarted: January 25, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
serum level of inflammatory cytokine changes during 3 time period

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

herpes zoster (acute) patients with intervention

Experimental

Patients with herpes zoster receiving 2 times of nerve block

Intervention: Herpes zoszter (acute)with inter vention (Procedure)

patients with chronic herpes zoster receiving 2 times of nerve block

Experimental

Patients with herpes zoster receiving 2 times of nerve block

Intervention: Herpes zoszter (acute)with inter vention (Procedure)

Outcomes

Primary Outcomes

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

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

  • Changes of numerical rating scale changes during 3 time period(Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

Study Sites (1)

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