- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568186
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
Recruiting
Conditions
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
Observational
Enrollment (Anticipated)
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
- Name: Xianwei Zhang, Doctor
- Phone Number: (+86)13037154560
- Email: ourpain@163.com
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430030
- Recruiting
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- cai'e Zhang, Doctor
- Email: zhangcaie1972@126.com
-
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
Ages Eligible for Study
16 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
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
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
Investigators
- 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)
October 1, 2022
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
October 1, 2022
First Submitted That Met QC Criteria
October 1, 2022
First Posted (Actual)
October 5, 2022
Study Record Updates
Last Update Posted (Actual)
October 5, 2022
Last Update Submitted That Met QC Criteria
October 1, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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