UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the pain associated with herpes zoster and postherpetic neuraligia
Title of the study (Brief title)	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	Kimiyasu Shiraki
Organization	University of Toyama
Division name	Department of Virology
Address	2630 Sugitani, Toyama 930-0194
TEL	076-434-7255
Email

Public contact
Name of contact person	Kimiyasu Shiraki
Organization	Universitu of Toyama
Division name	Department of Virology
Address	2630 Sugitani, Toyama 930-0194
TEL	076-434-7255
Homepage URL
Email	kshiraki@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 03 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010261