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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026719
Receipt No. R000030671
Scientific Title The elucidation for the risk factor of acute and chronic post-operative pain
Date of disclosure of the study information 2017/03/27
Last modified on 2019/07/27

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Basic information
Public title The elucidation for the risk factor of acute and chronic post-operative pain
Acronym The elucidation for the risk factor of acute and chronic post-operative pain
Scientific Title The elucidation for the risk factor of acute and chronic post-operative pain
Scientific Title:Acronym The elucidation for the risk factor of acute and chronic post-operative pain
Region
Japan

Condition
Condition dental surgery
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The ellucidation for the risk factor of acute and chronic post-operative pain
Basic objectives2 Others
Basic objectives -Others analyze of patient characteristics and CPM effect
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the relationship between the CPM effect and consumption amount and period using analgesic at before and after surgery
(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 the relationship between the Thermal Pain Illusion(TPI), Temporal Summation(TS), Offset Analgesia(OA), background (for example, psychology test including SDS, STAI, PCS etc) and consumption amount and period etc using analgesic. The effect of stress on Catecholamine concentrations in plasma and urine and sweat.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria scheduled dental surgery patient after informed consent is obtained, over 18 years old
Key exclusion criteria the inability to give informed consent, under 18 years old
Target sample size 90

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
2017 Year 03 Month 27 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
2017 Year 03 Month 27 Day
Date of IRB
2016 Year 12 Month 16 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 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
2017 Year 03 Month 27 Day
Last modified on
2019 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030671

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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