UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007319 |
|---|---|
| Receipt number | R000008559 |
| Scientific Title | A study on the analgesic effect of nerve root stimulation for postherpetic neuralgia |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2023/05/25 12:43:46 |
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Basic information
Public title
A study on the analgesic effect of nerve root stimulation for postherpetic neuralgia
Acronym
Analgesic effect of nerve root stimulation
Scientific Title
A study on the analgesic effect of nerve root stimulation for postherpetic neuralgia
Scientific Title:Acronym
Analgesic effect of nerve root stimulation
Region
| Japan |
Condition
Condition
Postherpetic neulargia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the analgesic effect of nerve root stimulation for postherpetic neuralgia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analgetic efficacy(VAS) from day1 to day7
Key secondary outcomes
The range of stimulation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Nerve root stimulation therapy is performed for seven days to the intractable postherpetic neuralgia patiants
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The intractable postherpetic neuralgia patient who accept sufficient analgetic effect by neither medication nor nerve block treatment
2)The patient who accepts the indication for spinal cord stimulation therapy
3)The patient who was able to get the consent by the document to this research
Key exclusion criteria
1)The patient from whom consent is not obtained by this research
2)The patient who judged that other doctors were inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fujio |
| Middle name | |
| Last name | Yanamoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunokicho,Kobe,Hyogo,Japan
TEL
078-382-6172
anesth@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Oi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunokicho,Kobe,Hyogo,Japan
TEL
078-382-6172
Homepage URL
mayuooi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Univ. Hosp. Clinical and Translational Research Center
Address
7-5-2 Kusunokicho,Kobe,Hyogo,Japan
Tel
078-382-6669
chiken@med.kobe-u.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
神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008559
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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