UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037522 |
|---|---|
| Receipt number | R000042780 |
| Scientific Title | Validation of simplified assessment tools for pain hypersensitivity in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/07/30 16:27:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation of simplified assessment tools for pain hypersensitivity in patients with knee osteoarthritis
Acronym
Assessments for pain hypersensitivity in patients with knee osteoarthritis
Scientific Title
Validation of simplified assessment tools for pain hypersensitivity in patients with knee osteoarthritis
Scientific Title:Acronym
Assessments for pain hypersensitivity in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate degree of pain hypersensitivity using validated laboratory tools and newly-developed simplified tools in Japanese knee osteoarthritis (KOA) patients
Basic objectives2
Others
Basic objectives -Others
To validate newly-developed simplified assessment tools for pain hypersensitivity compared with existing laboratory tools
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between pain hypersensitivity and clinical pain intensity evaluated by existing laboratory tools and newly-developed simplified tools
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Quantitative sensory testing using laboratory tools for patients and control subjects (single intervention)
Interventions/Control_2
Quantitative sensory testing using simplified tools for patients and control subjects (single intervention)
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
60 unilateral symptomatic KOA patients (included bilateral radiological KOA but unilateral symptoms)
20 control subjects without knee pain for 2 years
Key exclusion criteria
1) History of surgery for ipsilateral knee
2) Concomitant traumatic or inflammatory condition
3) Multiple musculoskeletal pain in other sites
4) Systemic inflammatory arthritis (RA, SpA, etc.)
5) Psychiatric disorders
Target sample size
80
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 Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi Prefecture, Japan
TEL
088-880-2386
izumim@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Taniuchi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi Prefecture, Japan
TEL
088-880-2386
Homepage URL
im35@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI & Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 Prefecture, Japan
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 | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2021 | 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=R000042780
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
