UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013801 |
|---|---|
| Receipt number | R000016111 |
| Scientific Title | Study of the effectiveness of intradiscal steroid injection for low back pain causede by degenerative disc with a vertebral end plate degeneration or disc instability |
| Date of disclosure of the study information | 2014/04/24 |
| Last modified on | 2014/04/24 19:17:48 |
* 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
Study of the effectiveness of intradiscal steroid injection for low back pain causede by degenerative disc with a vertebral end plate degeneration or disc instability
Acronym
Study of the effectiveness of steroid injection for discogenic low back pain
Scientific Title
Study of the effectiveness of intradiscal steroid injection for low back pain causede by degenerative disc with a vertebral end plate degeneration or disc instability
Scientific Title:Acronym
Study of the effectiveness of steroid injection for discogenic low back pain
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of the effectiveness of intradiscal steroid injection to discogenic low back pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric Rating Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vertebral body instability(-)
vertebral end plate degeneration(-)
Interventions/Control_2
Vertebral body instability(+)
vertebral end plate degeneration(-)
Interventions/Control_3
Vertebral body instability(+)
vertebral end plate degeneration(+)Modic1
Interventions/Control_4
Vertebral body instability(+)
vertebral end plate degeneration(+)Modic2
Interventions/Control_5
Vertebral body instability(-)
vertebral end plate degeneration(+)Modic1
Interventions/Control_6
Vertebral body instability(+)
vertebral end plate degeneration(+)Modic2
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
Low back pain patients with disc degeneration
Key exclusion criteria
patients who deemed inappropriate by physician as the object of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Tamagawa |
Organization
NTT Medical Center Tokyo
Division name
Pain Clinic
Zip code
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
t-tamagawa@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Tamagawa |
Organization
NTT Medical Center Tokyo
Division name
Pain Clinic
Zip code
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
Homepage URL
t-tamagawa@umin.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
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
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
| 2014 | Year | 04 | Month | 24 | 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
| 2014 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 25 | 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
| 2014 | Year | 04 | Month | 24 | Day |
Last modified on
| 2014 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016111
