Correlation Between Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype in Patients With Postherpetic Neuralgia

October 1, 2022 updated by: Xianwei Zhang，MD

Correlation Between Different Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype and Prognosis in Patients With Postherpetic Neuralgia

Postherpetic neuralgia (PHN) is the most frequent complication of herpes zoster(HZ) and is defined as pain persisting for >1month after the healing of herpetic skin lesion or pain persisting for > 3 months following the onset of HZ. PHN manifests as spontaneous throbbing, stabbing, or burning, usually accompanied by various abnormal sensory symptoms , which affect 5-20% of patients with HZ. Due to the lack of accurate and objective auxiliary examination tools, it is difficult for diagnosis and treatment of PHN. As a non-invasive examination method, infrared thermal imaging (IRT) can play a role in the diagnosis and treatment of neuropathic pain by objectively reflecting the changes and distribution characteristics of human body surface temperature. However, there are few studies on the relationship between clinical phenotype and thermal infrared image temperature changes in PHN patients, and the relationship between the thermal pattern of skin temperature and the duration of disease and treatment progress in PHN patients has not been fully elucidated. This study was conducted to investigate the relationship of thermal imaging data with the duration of the disease, clinical phenotype, treatment effect, in order to explore the role of infrared thermal imaging in the diagnosis and treatment of PHN. Methods：all PHN patients will included. At each visit, a pain NRS score was performed, and clinical phenotypes were tested and labeled, including: allodynia, numbness, itching, heat sensation, cold sensation, and the most painful area(MPA). Infrared thermal imaging was performed, the Average Relative Temperature (ART) within the affected area and the contralateral area was compared. The relationship between the temperature change and duration of the disease, clinical phenotype, treatment effect was assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

patients with the follow conditions were excluded: 1)The skin area was lesions because of other disease(trauma, inflammation, skin scar, skin disease, tumor, etc.); 2) history of psychiatric diseases, chronic pain. 3) inabilities to complete IRT examination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xianwei Zhang, Doctor
  • Phone Number: (+86)13037154560
  • Email: ourpain@163.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xueqin Cao, master

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all PHN patients in our hospital

Description

Inclusion Criteria:

  • 1) patients>18 years-old 2) pain lasts at least 1 month after lesion crusting 3) Agreed to participate the research

Exclusion Criteria:

  • 1))the skin area was lesions because of other disease(trauma, inflammation, skin scar, skin disease, tumor, etc.); 2) history of psychiatric diseases, chronic pain. 3)inabilities to complete IRT examination. 4) Disagree to participate to the research

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thermal pattern difference between affected side and contralateral side
Time Frame: 1 year
Thermal pattern difference between affected side and contralateral side
1 year
temperature difference between affected side and contralateral side
Time Frame: 1 year
temperature difference between affected side and contralateral side
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the relationship between the temperature change and disease duration
Time Frame: 1 year
the relationship between the temperature change and disease duration
1 year
the relationship between the temperature change and Pain Scores on Visual Analog Scale at each visit
Time Frame: 1 year
the relationship between the temperature change and Pain Scores on Visual Analog Scale at each visit
1 year
the relationship between the temperature change and clinical phenotype
Time Frame: 1 year
the relationship between the temperature change and clinical phenotype
1 year
the relationship between the temperature change and treatment effect
Time Frame: 1 year
the relationship between the temperature change and treatment effect
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xianwei Zhang，MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xianwei Zhang, Doctor, Huazhong University of Science and Technology

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Postherpetic Neuralgia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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