UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007674 |
|---|---|
| Receipt number | R000009047 |
| Scientific Title | The effect of Etanercept for epidural root block with Racz catheter |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2014/06/07 11:42:25 |
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Basic information
Public title
The effect of Etanercept for epidural root block with Racz catheter
Acronym
The Etanercept for root block
Scientific Title
The effect of Etanercept for epidural root block with Racz catheter
Scientific Title:Acronym
The Etanercept for root block
Region
| Japan |
Condition
Condition
Disc Herniaion
Lumber spinal canal stenosis
sciatica
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison Etanercept with Steroid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analgesic effect
Key secondary outcomes
side effect
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Epidural root block with etanercept
Interventions/Control_2
Epidural root block with steroid
Interventions/Control_3
Epidural root block with saline
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
The patients with chronic low back and leg pain for over half a year
Key exclusion criteria
The patients with poor general condition
The patient with bleeding tendency
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyuki Sakamoto |
Organization
The University of Shinshu school of medicine
Division name
Anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263352734
akiyuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakamoto Akiyuki |
Organization
The University of Shinshu school of medicine
Division name
Anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263352734
Homepage URL
akiyuki@shinshu-u.ac.jp
Sponsor or person
Institute
The Department of Anesthesiology and Resuscitology, Shinshu university school fo medicine
Institute
Department
Personal name
Funding Source
Organization
Non
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
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
| 2012 | Year | 04 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 05 | Day |
Last modified on
| 2014 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009047
