UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006731 |
|---|---|
| Receipt number | R000007950 |
| Scientific Title | A comparison of analgesic efficacy of constant current and constant voltage systems in spinal cord stimulation |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2023/05/25 12:36:26 |
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Basic information
Public title
A comparison of analgesic efficacy of constant current and constant voltage systems in spinal cord stimulation
Acronym
A comparison of analgesic efficacy of constant current and constant voltage systems
Scientific Title
A comparison of analgesic efficacy of constant current and constant voltage systems in spinal cord stimulation
Scientific Title:Acronym
A comparison of analgesic efficacy of constant current and constant voltage systems
Region
| Japan |
Condition
Condition
neuropathic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the analgesic efficacy of constant current and constant voltage stimulation systems in spinal cord stimulation (SCS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analgesic efficacy in both groups (VAS) from day1 to day10
Key secondary outcomes
pulse stability, the range of efficacy, and electricity consumption
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
From Day 1 to Day 5, a constant voltage pulse system and from Day 6 to Day 10, a constant current system was applied.
Interventions/Control_2
From Day 1 to Day 5, a constant current pulse system and from Day 6 to Day 10, a constant voltage system was applied.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The intractable pain patient who accepts sufficient analgesic effect by neither medication nor a nerve block treatment
2)The patient who accepts the indication for spinal cord stimulation therapy.
3)The patient who was able to get the consent by the document to this research
Key exclusion criteria
1)The patient from whom consent is not obtained by this research
2)The patient who judged that other doctors were inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fujio |
| Middle name | |
| Last name | Yanamoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunokicho,Kobe,Hyogo,Japan
TEL
078-382-6172
anesth@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Oi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunokicho,Kobe,Hyogo,Japan
TEL
078-382-6172
Homepage URL
mayuooi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
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
Kobe Univ. Hosp. Clinical and Translational Research Center
Address
7-5-2 Kusunokicho,Kobe,Hyogo,Japan
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007950
