UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060087 |
|---|---|
| Receipt number | R000068641 |
| Scientific Title | The riskfactor of postherpetic neuralgia |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/15 14:08:37 |
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Basic information
Public title
The riskfactor of postherpetic neuralgia
Acronym
The riskfactor of postherpetic neuralgia
Scientific Title
The riskfactor of postherpetic neuralgia
Scientific Title:Acronym
The riskfactor of postherpetic neuralgia
Region
| Japan |
Condition
Condition
Herpes zoster, Herpes zoster-associated pain, Postherpetic neuralgia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively investigate risk factors leading to the development of postherpetic neuralgia (PHN) among patients with herpes zoster, with a particular focus on elucidating the impact of patient frailty status on the onset of PHN. By doing so, we seek to establish scientific evidence for PHN risk stratification and preventive interventions, ultimately contributing to improved pain management and the maintenance of functional capacity in older adults.
Basic objectives2
Others
Basic objectives -Others
Postherpetic neuralgia (PHN) is a major complication of herpes zoster and markedly reduces quality of life due to prolonged pain management needs. Although age, female sex, immunosuppression, and rash severity are known risk factors, the role of frailty in PHN development remains unclear. Frailty may prolong neuropathic pain through aging-related mechanisms, chronic inflammation, and increased pain sensitivity.
This prospective study will assess acute-phase factors including frailty and identify independent predictors using multivariable analysis. Establishing PHN risk stratification may support preventive strategies such as vaccination and early individualized pain management.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of postherpetic neuralgia (PHN) at 3 months after the onset of herpes zoster
Key secondary outcomes
1. Pain scores (VAS, NRS, McGill Pain Questionnaire, PCS, EQ-5D, PDAS)
2. Analgesic consumption
3. Frailty (Barthel Index, Short Physical Performance Battery, J-CHS, J-CFS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who are within 3 months of herpes zoster onset at the time of consent
Patients who are able to provide informed consent to participate in the study
Key exclusion criteria
Patients already diagnosed with chronic pain in whom the initial pain screening makes it difficult to determine whether the pain is related to herpes zoster
Patients who are expected to be difficult to follow up
Patients with deformities or a history of surgery in the lower limbs or measurement sites that prevent accurate gait assessments or muscle thickness measurements
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Tsujikawa |
Organization
Osaka Metropolitan University
Division name
Anesthesiology
Zip code
545-8586
Address
1-5-7, Asahimachi, Abenoku, Osaka, Japan
TEL
0666452186
shogo.tsujikawa@gmail.com
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Tsujikawa |
Organization
Osaka Metropolitan University
Division name
Anesthesiology
Zip code
545-8586
Address
1-5-7, Asahimachi, Abenoku, Osaka, Japan
TEL
0666452186
Homepage URL
shogo.tsujikawa@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Departmental research funds
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Hospital Institutional Review Board
Address
1-5-7 Asahimachi, Abeno-ku, Osaka, Japan
Tel
06-6645-3447
med-shinki@ml.omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre reservation
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068641
