PainNCT07271784
Establishment of a Prediction Model for Postherpetic Neuralgia
An observational study of Pain and Neuropathic Pain, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This prospective cohort study enrolled 300 herpes zoster (HZ) patients at varying disease stages (1 week to 3 months post-onset) to investigate predictors of postherpetic neuralgia (PHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Neuropathic Pain, Biomarkers / Blood
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 24 Jun 2024
- How long will I take part?
- 3 Months
- 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: The subjects included patients with zoster associated pain who meet the inclusion and exclusion criteria for this study.
Who may be able to join
- Age ≥18 years Location of pain consistent with the HZ region and pain originating from herpes zoster (HZ)
Who cannot join
- Mental disorders, cognitive deficits, or coexisting painful diseases Severe cardio-cerebrovascular disease, hepatorenal insufficiency, infectious disease Cancer with a recurrence-free survival of less than one year Hematological disorders such as lymphoma or conditions such as acquired immune deficiency syndrome (AIDS) Psychiatric disorders; alcohol addiction; opioid abuse Previous treatment with interventional neurodestructive therapies or spinal cord stimulation (SCS)
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang
Hangzhou, Zhejiang, 310006
About this study
Official title: Establishment of a Prediction Model for Postherpetic Neuralgia Based on Immune Cell Typing
This prospective cohort study enrolled 300 herpes zoster (HZ) patients at varying disease stages (1 week to 3 months post-onset) to investigate predictors of postherpetic neuralgia (PHN). Comprehensive baseline data were collected, including demographic characteristics (age, sex, body mass index [BMI]), clinical comorbidities (hypertension, diabetes mellitus), disease-specific parameters (duration of zoster-associated pain [ZAP], dermatomal distribution, pregabalin dosage equivalents), and psychometric assessments using validated scales (Numerical Rating Scale [NRS], age-adjusted Charlson Comorbidity Index [aCCI], Generalized Anxiety Disorder-7 [GAD-7], Patient Health Questionnaire-9 [PHQ-9], and Insomnia Severity Index [ISI]). Laboratory evaluations encompassed routine hematological tests (complete blood count [CBC], hepatic/renal function), metabolic profiling (triglycerides [TG], total cholesterol [TC], lipoprotein subfractions), inflammatory markers (erythrocyte sedimentation rate [ESR], comprehensive cytokine panel including interleukins [IL] and interferons [IFN]), and detailed immunophenotyping via multicolor flow cytometry of peripheral blood lymphocytes. After a 3-month follow-up, patients were to be stratified into PHN and non-PHN groups based on pain persistence. The use of least absolute shrinkage and selection operator (LASSO) regression analysis was planned to identify significant predictive factors and develop a multivariate model, with the aim of establishing a precision medicine framework for early PHN risk stratification through integrated analysis of clinical and immunological parameters.
- Conditions
- Pain, Neuropathic Pain, Biomarkers / Blood
- Keywords
- Postherpetic neuralgia, biomarker
- Medical subject headings
- Pain, Neuralgia, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PHN Group | Patients with herpes zoster were classified into the postherpetic neuralgia (PHN) group if they had a Numerical Rating Scale (NRS) pain score ≥1 at 3 months after disease onset. | |
| non-PHN Group | Patients with herpes zoster were classified into the non postherpetic neuralgia (non-PHN) group if they had a Numerical Rating Scale (NRS) pain score of 0 at 3 months after disease onset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Postherpetic Neuralgia (PHN) as Assessed by the Numerical Rating Scale (NRS) at 3 months after herpes zoster onset.
HN is defined as pain that persists in the area affected by the herpes zoster rash after the acute rash has healed, and that is present at 3 months after rash onset. The presence and intensity of this pain will be assessed using the Numerical Rating Scale (NRS), with an NRS score of ≥ 1 used as the threshold to define the presence of clinically pain. Study participants will be categorized based on the presence of PHN at the 3-month timepoint according to this definition.
Measured: At the 3-month timepoint after herpes zoster onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Sep 2023
- Primary completion24 May 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiying Feng, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271784
- Sponsor's protocol ID
- [2023B] IIT.No.0673
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Prediction Model for Postherpetic Neuralgia Based on Immune Cell Typing
- ClinicalTrials.gov ID
- NCT07271784
- Acronym / sponsor ID
- [2023B] IIT.No.0673
- Conditions
- Pain, Neuropathic Pain, Biomarkers / Blood
- Keywords
- Postherpetic neuralgia, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 9 Dec 2025 (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.
This prospective cohort study enrolled 300 herpes zoster (HZ) patients at varying disease stages (1 week to 3 months post-onset) to investigate predictors of postherpetic neuralgia (PHN). Comprehensive baseline data were collected, including demographic characteristics (age, sex, body mass index [BMI]), clinical comorbidities (hypertension, diabetes mellitus), disease-specific parameters (duration of zoster-associated pain [ZAP], dermatomal distribution, pregabalin dosage equivalents), and psychometric assessments using validated scales (Numerical Rating Scale [NRS], age-adjusted Charlson Comorbidity Index [aCCI], Generalized Anxiety Disorder-7 [GAD-7], Patient Health Questionnaire-9 [PHQ-9], and Insomnia Severity Index [ISI]). Laboratory evaluations encompassed routine hematological tests (complete blood count [CBC], hepatic/renal function), metabolic profiling (triglycerides [TG], total cholesterol [TC], lipoprotein subfractions), inflammatory markers (erythrocyte sedimentation rate [ESR], comprehensive cytokine panel including interleukins [IL] and interferons [IFN]), and detailed immunophenotyping via multicolor flow cytometry of peripheral blood lymphocytes. After a 3-month follow-up, patients were to be stratified into PHN and non-PHN groups based on pain persistence. The use of least absolute shrinkage and selection operator (LASSO) regression analysis was planned to identify significant predictive factors and develop a multivariate model, with the aim of establishing a precision medicine framework for early PHN risk stratification through integrated analysis of clinical and immunological parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHN Group | – | –Patients with herpes zoster were classified into the postherpetic neuralgia (PHN) group if they had a Numerical Rating Scale (NRS) pain score ≥1 at 3 months after disease onset. |
| non-PHN Group | – | –Patients with herpes zoster were classified into the non postherpetic neuralgia (non-PHN) group if they had a Numerical Rating Scale (NRS) pain score of 0 at 3 months after disease onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects included patients with zoster associated pain who meet the inclusion and exclusion criteria for this study.
Key inclusion criteria (1 listed)
- Age ≥18 years Location of pain consistent with the HZ region and pain originating from herpes zoster (HZ)
Key exclusion criteria (1 listed)
- Mental disorders, cognitive deficits, or coexisting painful diseases Severe cardio-cerebrovascular disease, hepatorenal insufficiency, infectious disease Cancer with a recurrence-free survival of less than one year Hematological disorders such as lymphoma or conditions such as acquired immune deficiency syndrome (AIDS) Psychiatric disorders; alcohol addiction; opioid abuse Previous treatment with interventional neurodestructive therapies or spinal cord stimulation (SCS)
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
Occurrence of Postherpetic Neuralgia (PHN) as Assessed by the Numerical Rating Scale (NRS) at 3 months after herpes zoster onset.
Time frame: At the 3-month timepoint after herpes zoster onset.
HN is defined as pain that persists in the area affected by the herpes zoster rash after the acute rash has healed, and that is present at 3 months after rash onset. The presence and intensity of this pain will be assessed using the Numerical Rating Scale (NRS), with an NRS score of ≥ 1 used as the threshold to define the presence of clinically pain. Study participants will be categorized based on the presence of PHN at the 3-month timepoint according to this definition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain and Neuropathic Pain, run by First Affiliated Hospital of Zhejiang University 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Postherpetic Neuralgia (PHN) as Assessed by the Numerical Rating Scale (NRS) at 3 months after herpes zoster onset. (time frame: At the 3-month timepoint after herpes zoster onset.). 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 9 Dec 2025.