UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008738 |
|---|---|
| Receipt number | R000010261 |
| Scientific Title | Research on the pain associated with herpes zoster and postherpetic neuraligia |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2019/03/05 15:14:30 |
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Basic information
Public title
Research on the pain associated with herpes zoster and postherpetic neuraligia
Acronym
Pain in herpes zoster and PHN
Scientific Title
Research on the pain associated with herpes zoster and postherpetic neuraligia
Scientific Title:Acronym
Pain in herpes zoster and PHN
Region
| Japan |
Condition
Condition
Zoster accociated pain and postherpetic neuralgia
Classification by specialty
| Neurology | Infectious disease | Dermatology |
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze the nature and distribution of pain in herpes zoster and postherpetic neuraligia.
Basic objectives2
Others
Basic objectives -Others
We evaluate the nature of pain and its distibution in and around the lesion of herpes zoster by the algisimeter in patients with herpes zoster and postherpetic neuraligia (PHN). We assess the distiribution of pain spots assessed by the algisimeter in the healthy adults and anlyze the correlation of distribution of pain spots and the pain distribution in patients with herpes zoster and PHN.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Distibution of pain spots in healthy adults.
Relationship of the distibutions between herpetic skin lesions and pain density as well as allodynia regions.
Relationship in the dermatomes between pain spot distribution and suscptibility to zoster^associated pain or PHN.
Key secondary outcomes
The contribution of age, gender, underlying dieases, drugs on the evaluation above.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who agreed to measure pain spots by algesimeter.
Patietns who agreed to measure pain spots by algesimeter.
Key exclusion criteria
Paitents whose herpetic lesions are not suitable for the use of algesimeter.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiyasu Shiraki |
Organization
University of Toyama
Division name
Department of Virology
Zip code
Address
2630 Sugitani, Toyama 930-0194
TEL
076-434-7255
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiyasu Shiraki |
Organization
Universitu of Toyama
Division name
Department of Virology
Zip code
Address
2630 Sugitani, Toyama 930-0194
TEL
076-434-7255
Homepage URL
kshiraki@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
school fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Anethesiology, University of Toyama
Department fo Anethesiology, Nihon University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
富山大学病院
日本大学板橋病院、駿河台病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 20 | 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
Distribution and density of pain spots were determined in one healthy volunteer as the standard reference of pain spots. The distribution and nature of pain were determined in 21 patients with postherpetic neuralgia.
we have finished the pain point measurement. The manuscript is under preparation.
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Medical records on the patients with herpes zoster and PHN are retrospectively surveyed for the distibution and nature of pain to analyze the localization of pain and nature in around 500 patients.
Pain spots in healthy adults are measured after informed consent of partiticpation in the study.
Pain spots and their nature in patients with herpes zoster and PHN are evaluated by algesimeter after informed consent of partiticpation in the study
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010261
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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