UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037547
Receipt number R000042810
Scientific Title The development of new evaluation method with QST and CPM for chronic pain patient
Date of disclosure of the study information 2019/07/30
Last modified on 2019/07/30 20:32:22

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Basic information

Public title

The development of new evaluation method with QST and CPM for chronic pain patient

Acronym

The development of new evaluation method with QST and CPM for chronic pain patient

Scientific Title

The development of new evaluation method with QST and CPM for chronic pain patient

Scientific Title:Acronym

The development of new evaluation method with QST and CPM for chronic pain patient

Region

Japan


Condition

Condition

pain patient and healthy volunteers

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The development of new evaluation method with QST and CPM for chronic pain patient

Basic objectives2

Others

Basic objectives -Others

the evaluation of modulation of QST and CPM in pain patient compared to the helthy volunteers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the modulation of CPM in pain patient compared to the helthy volunteers
(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. 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

the modulation of QST (the Thermal Pain Illusion(TPI), Temporal Summation(TS), Offset Analgesia(OA) etc) and the effect of background (for example, psychology test including SDS, STAI, PCS etc), analgesics and the stress evaluated by Catecholamine concentrations in plasma, urine and sweat in pain patient compared to the healthy volunteers


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

after informed consent is obtained, over 16 years old

Key exclusion criteria

the inability to give informed consent, under 16 years old

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Yuka
Middle name
Last name Oono

Organization

Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry

Division name

Division of Dental Anesthesiology

Zip code

350-0283

Address

1-1, Keyakidai, Sakado-shi, Saitama

TEL

0492792738

Email

yoono@dent.meikai.ac.jp


Public contact

Name of contact person

1st name Yuka
Middle name
Last name Oono

Organization

Department of Diagnostic and Therapeutic Sciences, School of Dentistry, Meikai University

Division name

Division of Dental Anesthesiology

Zip code

350-0283

Address

1-1, Keyakidai, Sakado-shi, Saitama

TEL

049-279-2738

Homepage URL


Email

yoono@dent.meikai.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Meikai University

Address

1-1, Keyakidai, Sakado-shi, Saitama

Tel

049-279-2712

Email

kenkyu@dent.meikai.ac.jp


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

2019 Year 07 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

Enrolling by invitation

Date of protocol fixation

2019 Year 07 Month 30 Day

Date of IRB

2015 Year 06 Month 20 Day

Anticipated trial start date

2019 Year 07 Month 31 Day

Last follow-up date

2020 Year 06 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Tonic conditioning stimulus (CS) is applied to the forearm by quantitative thermal stimulator device (QTSD) with a pain intensity of 70 on VAS (0-100) for about 5 minutes. For CPM evaluation, pressure pain threshold (PPT) is measured at contralateral forearm before, during, and after CS.


Management information

Registered date

2019 Year 07 Month 30 Day

Last modified on

2019 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name