UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020004 |
|---|---|
| Receipt number | R000023077 |
| Scientific Title | Evaluation of Conditioned Pain Modulation with a quantitative thermal stimulator device |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2017/06/01 13:21:43 |
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Basic information
Public title
Evaluation of Conditioned Pain Modulation with a quantitative thermal stimulator device
Acronym
Evaluation of Conditioned Pain Modulation with a quantitative thermal stimulator device
Scientific Title
Evaluation of Conditioned Pain Modulation with a quantitative thermal stimulator device
Scientific Title:Acronym
Evaluation of Conditioned Pain Modulation with a quantitative thermal stimulator device
Region
| Japan |
Condition
Condition
healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the objective evaluation of Conditioned Pain Modulation (CPM), test stimulus (TS) and conditioning stimulus (CS) should be quantified. We have developed a new pressure algometer to measure quantitative pressure pain threshold (PPT) and have reported that the new algometer is useful to use as TS to evaluate CPM. We have also developed a quantitative thermal stimulator device (QTSD) to deliver quantitative thermal stimulus. The QTSD is designed as it is possible to switch the temperature (heat and cold). The aim of the study is to investigate whether QTSD is useful as CS to evaluate CPM or other sensation.
Basic objectives2
Others
Basic objectives -Others
For the objective evaluation of Conditioned Pain Modulation (CPM), test stimulus (TS) and conditioning stimulus (CS) should be quantified. We have developed a new pressure algometer to measure quantitative pressure pain threshold (PPT) and have reported that the new algometer is useful to use as TS to evaluate CPM. We have also developed a quantitative thermal stimulator device (QTSD) to deliver quantitative thermal stimulus. The QTSD is designed as it is possible to switch the temperature (heat and cold). The aim of the study is to investigate whether QTSD is useful as CS to evaluate CPM or other sensation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPM effect
Evaluation of CPM effect is assessed by Quantitative Sensory Testing (QST) such as Pressure Pain threshold measured by pressure algometer or threshold measured by von Frey filament as subjective evaluation and objective evaluation by Visual Analogue Scale (VAS) etc. The CPM effect is evaluated during and after conditioning stimulation. CPM effect is defined as ratio of pain threshold of TS during CS to pain threshold before application of CS (baseline).
Key secondary outcomes
modulation of sensation by QTSD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Tonic CS is applied to the forearm by QTSD with a pain intensity of 70 on VAS (0-100) for about 6 minutes. For CPM evaluation, PPT is measured at contralateral forearm before, during, and after CS.
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
healthy adult volunteers after informed consent is obtained
Key exclusion criteria
(1) a medical condition such as neurological, psychiatric diseases; (2) the inability to give informed consent; and (3) the current use of analgesic drugs, anti-depressants, or cough suppressants.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hikaru Kohase |
Organization
Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Division name
Division of Dental Anesthesiology
Zip code
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
049-279-2738
hkohase@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hikaru Kohase |
Organization
Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Division name
Division of Dental Anesthesiology
Zip code
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
049-279-2738
Homepage URL
hkohase@dent.meikai.ac.jp
Sponsor or person
Institute
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Sensory-Motor Interaction (SMI), Aalborg University
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
| 2015 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | 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
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023077
