UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034249 |
|---|---|
| Receipt number | R000039039 |
| Scientific Title | Effect of corticosteroid injection after nerve block on blood glucose levels |
| Date of disclosure of the study information | 2018/10/03 |
| Last modified on | 2020/09/24 11:33:40 |
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Basic information
Public title
Effect of corticosteroid injection after nerve block on blood glucose levels
Acronym
corticosteroid and blood glucose
Scientific Title
Effect of corticosteroid injection after nerve block on blood glucose levels
Scientific Title:Acronym
corticosteroid and blood glucose
Region
| Japan |
Condition
Condition
lumbar facet pain, lumbosacral radicular pain
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to clarify patient factors which tend to cause blood glucose level abnormality after steroid injection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under curve (AUC) of blood glucose level and time when blood glucose level exceeds 200 mg / ml.
Key secondary outcomes
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
Patients who scheduled to inject corticosteroid locally after lumbosacral radicular nerve root block or lumbar facet block
Key exclusion criteria
Patients who are judged that steroid injection is inadequate due to coexistence of severe diabetes etc.
Patients who have ever received steroids within the past 3 months
Patient scheduled for image retrieval (excluding ultrasound) during the observation period
Patients who are judged unsuitable as subjects by doctor's judgment
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Yanagido 1-1, Gifu City
TEL
058-230-6404
kumiko-t@m2.gyao.ne.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Yanagido 1-1, Gifu City
TEL
058-230-6404
Homepage URL
kumiko-t@m2.gyao.ne.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
Gifu University GraduateSchool of Medicine
Address
Yanagido1-1 Gifu City
Tel
058-230-6059
rinri@gifu-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 03 | 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
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
blood glucose values obtained from continuous glucose monitoring system
Management information
Registered date
| 2018 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039039
| 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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| Registered date | File name |
