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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05568186
Other study ID # postherpetic neuralgia
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2023

Study information

Verified date October 2022
Source Huazhong University of Science and Technology
Contact Xianwei Zhang, Doctor
Phone (+86)13037154560
Email ourpain@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 166
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Xianwei Zhang,MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thermal pattern difference between affected side and contralateral side Thermal pattern difference between affected side and contralateral side 1 year
Primary temperature difference between affected side and contralateral side temperature difference between affected side and contralateral side 1 year
Secondary the relationship between the temperature change and disease duration the relationship between the temperature change and disease duration 1 year
Secondary the relationship between the temperature change and Pain Scores on Visual Analog Scale at each visit the relationship between the temperature change and Pain Scores on Visual Analog Scale at each visit 1 year
Secondary the relationship between the temperature change and clinical phenotype the relationship between the temperature change and clinical phenotype 1 year
Secondary the relationship between the temperature change and treatment effect the relationship between the temperature change and treatment effect 1 year
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