UMIN-CTR Clinical Trial

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

healthy adult volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Center for Sensory-Motor Interaction (SMI), Aalborg University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Published

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

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 related 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