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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037522
Receipt No. 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 2019/09/14

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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
Email 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
Email im35@kochi-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Kochi Medical School, Kochi University
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.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


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