UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038816 |
|---|---|
| Receipt number | R000044256 |
| Scientific Title | Development of simple and multimodal evaluation of pain sensitization for patients with chronic pain Phase 1: Validation study of practical QST (pQST) Phase 2: Development of normative pQST data in healthy subjects |
| Date of disclosure of the study information | 2019/12/16 |
| Last modified on | 2020/12/23 18:17:04 |
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Basic information
Public title
Development of simple and multimodal pain evaluation for patients with chronic pain
Phase 1: Validation study of practical QST (pQST)
Phase 2: Development of normative pQST data in healthy subjects
Acronym
Development of simple and multimodal pain evaluation for patients with chronic pain
Phase 1: Validation study of practical QST (pQST)
Phase 2: Development of normative pQST data in healthy subjects
Scientific Title
Development of simple and multimodal evaluation of pain sensitization for patients with chronic pain
Phase 1: Validation study of practical QST (pQST)
Phase 2: Development of normative pQST data in healthy subjects
Scientific Title:Acronym
Development of simple and multimodal evaluation of pain sensitization for patients with chronic pain
Phase 1: Validation study of practical QST (pQST)
Phase 2: Development of normative pQST data in healthy subjects
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Medicine in general | Neurology | Clinical immunology |
| Psychosomatic Internal Medicine | Geriatrics | Psychiatry |
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate validity of new simple assessment tool for pain sensitization (practical QST: pQST) and develop normative data of the assessment in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of the pain sensitization parameters (pressure pain threshold: PPT, temporal summation of pain: TS, conditioned pain modulation: CPM) evaluated by established tool and new simple tool
Key secondary outcomes
Distribution of the PPT, TS, and CPM data in healthy subjects considering with age and gender effects
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
To evaluate pain sensitization parameters (PPT, TS, CPM) using established tool
Interventions/Control_2
To evaluate pain sensitization parameters (PPT, TS, CPM) using new simple tool (pQST)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects with systemically no pain
Key exclusion criteria
1.acute inflammatory condition (ex. trauma, infection)
2.post-surgical pain within 6 months
3.skin disorders around pain assessment area
4.Psychological disorders (ex. dementia)
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Izumi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopedic surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi Pref.
TEL
088-880-2386
izumim@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Morita |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopedic surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi Pref.
TEL
088-880-2386
Homepage URL
im35@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi Pref.
Tel
088-880-2180
is21@kochi-u.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 | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044256
