UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042780