Postherpetic NeuralgiaNCT05568186
Correlation Between Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype in Patients With Postherpetic Neuralgia
An observational study of Postherpetic Neuralgia and Infrared Thermal Imaging, run by Xianwei Zhang，MD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Infrared Thermal Imaging
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all PHN patients in our hospital
Who may be able to join
- 1) patients>18 years-old 2) pain lasts at least 1 month after lesion crusting 3) Agreed to participate the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
cai'e Zhang, Doctor, zhangcaie1972@126.com
Xueqin Cao, master
About this study
Official title: 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.
Read the 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.
- Conditions
- Postherpetic Neuralgia, Infrared Thermal Imaging
- Keywords
- postherpetic neuralgia, infrared thermal imaging, clinical phenotype, disease course
- Medical subject headings
- Neuralgia, Postherpetic, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal pattern difference between affected side and contralateral side
Thermal pattern difference between affected side and contralateral side
Measured: 1 year
temperature difference between affected side and contralateral side
temperature difference between affected side and contralateral side
Measured: 1 year
Secondary outcomes (4)
the relationship between the temperature change and disease duration
the relationship between the temperature change and disease duration
Measured: 1 year
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
Measured: 1 year
the relationship between the temperature change and clinical phenotype
the relationship between the temperature change and clinical phenotype
Measured: 1 year
the relationship between the temperature change and treatment effect
the relationship between the temperature change and treatment effect
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xianwei Zhang，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xianwei Zhang，MD, Huazhong University of Science and Technology
- Investigators
- Xianwei Zhang, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568186
- Sponsor's protocol ID
- postherpetic neuralgia
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Different Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype and Prognosis in Patients With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT05568186
- Acronym / sponsor ID
- postherpetic neuralgia
- Conditions
- Postherpetic Neuralgia, Infrared Thermal Imaging
- Keywords
- postherpetic neuralgia, infrared thermal imaging, clinical phenotype, disease course
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Xianwei Zhang，MDUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all PHN patients in our hospital
Key inclusion criteria (1 listed)
- 1) patients>18 years-old 2) pain lasts at least 1 month after lesion crusting 3) Agreed to participate the research
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thermal pattern difference between affected side and contralateral side
Time frame: 1 year
Thermal pattern difference between affected side and contralateral side
temperature difference between affected side and contralateral side
Time frame: 1 year
temperature difference between affected side and contralateral side
4 secondary outcomes
the relationship between the temperature change and disease duration
Time frame: 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 clinical phenotype
Time frame: 1 year
the relationship between the temperature change and treatment effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianwei Zhang, Doctor principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postherpetic Neuralgia and Infrared Thermal Imaging, run by Xianwei Zhang，MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianwei Zhang, Doctor ((+86)13037154560, ourpain@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal pattern difference between affected side and contralateral side (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.