UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008670 |
|---|---|
| Receipt number | R000010003 |
| Scientific Title | The safety and efficacy of intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain |
| Date of disclosure of the study information | 2012/08/10 |
| Last modified on | 2012/08/10 18:34:01 |
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Basic information
Public title
The safety and efficacy of intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain
Acronym
Intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain
Scientific Title
The safety and efficacy of intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain
Scientific Title:Acronym
Intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain
Region
| Japan |
Condition
Condition
chronic low back and lower extremity pain
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of a novel alternative therapy to epidural injection for chronic lumbar pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Modified Bromage scale
Lower Extremity Motor ScoreBlood
Upper dermatome of sensory block
pressure and pulse rate
Key secondary outcomes
Numerical rating Scale
JOA score
Roland Morris disability questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Intrathecal injection of bupivacaine
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
Outpatients with chronic low back pain with or without lower extremity pain
Age: 20 years or older
Patients capable of proper assessment
Moderately troublesome pain
Duration: at least 3 months
Specific disorder explaining the pain
Key exclusion criteria
Serious cause of pain (ie, infection, fracture, malignancy)
Extensive neurological deficit affecting the anesthetic assessments
Severe psychological diseases
Serious chronic diseases such as cardiac failure, pulmonary emphysema, and interstitial hepatitis
Contraindication to intrathecal injection
Previous intrathecal injection therapy
Other medications initiated within one week before the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Kanai |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-15-1 Kitasato, Sagamihara 252-0374 Japan
TEL
042-778-8606
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akifumi Kanai |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8606
Homepage URL
kanaiakifumi@aol.com
Sponsor or person
Institute
Department of Anesthesiology, Kitasato University School of Medicine
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
None
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
北里大学医学部麻酔科/Department of Anesthesiology, Kitasato University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 10 | Day |
Last modified on
| 2012 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010003
| 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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| Registered date | File name |
