UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012566 |
|---|---|
| Receipt number | R000014700 |
| Scientific Title | anti-cytokine therapy for discogenic low back pain |
| Date of disclosure of the study information | 2013/12/12 |
| Last modified on | 2013/12/12 21:24:06 |
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Basic information
Public title
anti-cytokine therapy for discogenic low back pain
Acronym
ACDLP
Scientific Title
anti-cytokine therapy for discogenic low back pain
Scientific Title:Acronym
ACDLP
Region
| Japan |
Condition
Condition
discogenic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Search of new treatment for discogenic low back pain by anti-cytokine therapy, and evaluation of adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. analgesic effect 2. adverse events
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.intradiscal administration of local anesthetic agent group
Interventions/Control_2
2.intradiscal administration of local anesthetic agent and anti-TNFa inhibitor group
Interventions/Control_3
3.intradiscal administration of local anesthetic agent and anti-IL6 inhibitor group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.low back pain
2.X-ray and MRI can explain the condition
3.less than 2 disc degeneration
4.agreement with this study
5.refractory to 3 months of conservative treatments
Key exclusion criteria
1.loss of consiousness
2.case with history of spinal surgery, infection
3.severe systemic complications
4.diabetes mellitus
5.psychiatric disease
6.pregnant women and women suspected of being pregnant
7.case with malignancy
8.the case considered to be unsuitable as a subject
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2117
sohotri@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Sainoh |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2117
Homepage URL
sain3005@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery,Graduate School of Medicine,Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery,Graduate School of Medicine,Chiba 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
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
| 2013 | Year | 12 | Month | 12 | 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
| 2009 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 13 | 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
| 2013 | Year | 12 | Month | 12 | Day |
Last modified on
| 2013 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014700
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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