UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034249
Receipt No. 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 2018/10/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kumiko Tanabe
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Yanagido 1-1, Gifu City
TEL 058-230-6404
Email kumiko-t@m2.gyao.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko Tanabe
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Yanagido 1-1, Gifu City
TEL 058-230-6404
Homepage URL
Email kumiko-t@m2.gyao.ne.jp

Sponsor
Institute Gifu University
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 04 Day
Last follow-up date
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
2018 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039039

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.