UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Conditioned Pain Modulation with a quantitative thermal stimulator device
Title of the study (Brief title)	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	Hikaru Kohase
Organization	Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Division name	Division of Dental Anesthesiology
Address	1-1, Keyakidai, Sakado-shi, Saitama
TEL	049-279-2738
Email	hkohase@dent.meikai.ac.jp

Public contact
Name of contact person	Hikaru Kohase
Organization	Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University
Division name	Division of Dental Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023077