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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020004
Receipt No. 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

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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
Email 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
Email hkohase@dent.meikai.ac.jp

Sponsor
Institute Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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