UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009342 |
|---|---|
| Receipt number | R000010971 |
| Scientific Title | study of usefulness of the cold laser(Lumix2) in the pain clinic of a oral and maxillofacial |
| Date of disclosure of the study information | 2012/11/30 |
| Last modified on | 2012/11/15 20:59:01 |
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Basic information
Public title
study of usefulness of the cold laser(Lumix2) in the pain clinic of a oral and maxillofacial
Acronym
study of usefulness of the phototherapy to chronic sharp pain
Scientific Title
study of usefulness of the cold laser(Lumix2) in the pain clinic of a oral and maxillofacial
Scientific Title:Acronym
study of usefulness of the phototherapy to chronic sharp pain
Region
| Japan |
Condition
Condition
adult
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It serches about the usefulness of the cold laser in the pain clinic of the oral and maxillofacial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.temperature of a cheek part
2.temperature of the eardrum
3.face skin blood flow
4.blood pressure,pulse,percutaneous oxigen saturation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the stellate ganglion of one side is irradiated with the cold laser of 40KHz-70% of output for 10 minites
Interventions/Control_2
the stellate ganglion of one side is irradiated with 18J Xenon light at 1 time per 3.5 second of a rate
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
the adult fully explained about this study and consent was got
Key exclusion criteria
the adult fully explained about this study and consent was not got
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya NAGOH |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Depertment of Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Depertment of Anesthesiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
self funding
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 | 11 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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 | 11 | Month | 15 | Day |
Last modified on
| 2012 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010971
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
