UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042810