Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study

March 10, 2025 updated by: Do Thanh Sang

Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study Conducted At Le Van Thinh Hospital, Vietnam

This study investigates the relationship between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study aims to integrate objective pain assessment tools, such as the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, with TCM diagnostic classifications to enhance individualized treatment strategies. Conducted at Le Van Thinh Hospital, Vietnam, this cross-sectional study includes 80 HZ patients, assessing their pain levels and corresponding TCM syndromes. The findings will contribute to a more comprehensive approach to pain management in Herpes Zoster.

Study Overview

Status

Not yet recruiting

Detailed Description

This study is a cross-sectional and case series study conducted at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam, between January and June 2024. It aims to evaluate the correlation between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study includes 80 participants diagnosed with HZ, whose pain severity is assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. The participants are classified into TCM syndromes based on standard diagnostic criteria, including Liver Meridian Depression and Heat Syndrome (LMD), Spleen Deficiency and Dampness Retention Syndrome (SDA), and Qi Stagnation and Blood Stasis Syndrome (QSA).

The primary objectives of the study are:

To determine the prevalence of different TCM syndromes in HZ patients. To analyze the correlation between LANSS scores and specific TCM syndromes. To provide insights into the integration of objective neuropathic pain assessment tools with traditional diagnostic frameworks.

Data collection includes demographic characteristics, medical history, pain characteristics, TCM diagnostic features, and clinical examination results. Statistical analyses include correlation tests and multinomial logistic regression to assess the relationship between LANSS pain scores and TCM syndromes.

The study findings will contribute to a better understanding of the relationship between neuropathic pain and TCM syndromes in Herpes Zoster. The results may help refine diagnostic approaches and optimize integrative treatment strategies for pain management in patients with HZ.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Viet Nam
      • Ho Chi Minh, Viet Nam, Vietnam, 700000
        • Le Van Thinh Hospital
        • Contact:
        • Contact:
          • Sang Do

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of 80 adult patients diagnosed with Herpes Zoster (shingles) who presented at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. These patients were experiencing neuropathic pain and were assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. Participants were classified into Traditional Chinese Medicine (TCM) syndromes based on diagnostic criteria

Description

Inclusion Criteria:

  • Adults aged ≥18 years
  • Clinically diagnosed with Herpes Zoster (HZ) based on European Consensus Guidelines
  • Experiencing neuropathic pain associated with HZ
  • Willing to provide informed consent

Exclusion Criteria:

  • History of chronic pain conditions unrelated to HZ
  • Receiving immunosuppressive therapy or diagnosed with immunodeficiency disorders
  • Patients who had already received antiviral or analgesic treatment before evaluation
  • Patients unable or unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Severity in Herpes Zoster Patients
Time Frame: Baseline (Day 1)
Measured using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale. LANSS scores will be used to determine the severity of neuropathic pain in study participants.
Baseline (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Neuropathic Pain and Traditional Medicine Syndromes
Time Frame: Baseline (Day 1).
Analysis of LANSS scores and their association with Traditional Chinese Medicine (TCM) syndromes (Liver Meridian Depression and Heat Syndrome, Spleen Deficiency and Dampness Retention Syndrome, and Qi Stagnation and Blood Stasis Syndrome) using multinomial logistic regression.
Baseline (Day 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2025

Primary Completion (Estimated)

May 12, 2025

Study Completion (Estimated)

May 12, 2025

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Zoster (HZ)

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