UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053811 |
|---|---|
| Receipt number | R000061404 |
| Scientific Title | Efficacy and complications of combined pulsed radiofrequency and low-temperature thermal radiofrequency of the gasserian ganglion in patients with trigeminal neuralgia. |
| Date of disclosure of the study information | 2024/03/20 |
| Last modified on | 2024/04/14 12:50:13 |
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Basic information
Public title
Efficacy and complications of combined pulsed radiofrequency and low-temperature thermal radiofrequency of the gasserian ganglion in patients with trigeminal neuralgia.
Acronym
Efficacy and complications of combined pulsed radiofrequency and low-temperature thermal radiofrequency in the treatment of trigeminal neuralgia.
Scientific Title
Efficacy and complications of combined pulsed radiofrequency and low-temperature thermal radiofrequency of the gasserian ganglion in patients with trigeminal neuralgia.
Scientific Title:Acronym
Efficacy and complications of combined pulsed radiofrequency and low-temperature thermal radiofrequency in the treatment of trigeminal neuralgia.
Region
| Japan |
Condition
Condition
Trigeminal Neuralgia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and complications of combined pulsed radiofrequency and low-temperature thermal radiofrequency of the gasserian ganglion in patients with trigeminal neuralgia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale
Key secondary outcomes
Barrow Neurological Institute Pain Intensity Score (BNI-P)
Barrow Neurological Institute Facial Numbness Score (BNI-N)
Likert score
Numbness level from 0 to 10
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
# Trigeminal neuralgia patients approved by ethics committee
# NRS>=5
# BNI-P score:3b-5
# BNI-N score:3-4
# Trigeminal neuralgia patients met the diagnostic criteria for gasserian ganglion blockage
# Written concent to participate in this study
# Age>=18years
Key exclusion criteria
# Pregnant women
# Allagy to contrast agent and propofol
# Seriou systemic diseases that can influence the assessment of this study
# Judged as unmet by reserchers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Kamijima |
Organization
NTT Medical Center Tokyo
Division name
Pain clinic
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL
0334486031
painnttk@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Hagihara |
Organization
Kagoshima University
Division name
Anesthesiology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
0992755430
Homepage URL
hagihasg2@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Kenya Kamijima
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Kagoshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima Univerity
Address
8-35-1 Sakuragaoka, Kagoshima, Japan.
Tel
0992755430
hagihasg2@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
000200011361-01
Org. issuing International ID_1
NTT Medical Center Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
NTT東日本関東病院(東京都)、鹿児島大学病院(鹿児島)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently in the process of applying.
Management information
Registered date
| 2024 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061404
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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