UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the pathology and mechanism of neuropathic pain in osteoarthritis of hip
Acronym	Analysis of the pathology and mechanism of neuropathic pain in osteoarthritis of hip
Scientific Title	Analysis of the pathology and mechanism of neuropathic pain in osteoarthritis of hip
Scientific Title:Acronym	Analysis of the pathology and mechanism of neuropathic pain in osteoarthritis of hip
Region	Japan

Condition
Condition	osteoarthritis of the hip
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. To clarify the proportion of neuropathic pain by stage of osteoarthritis. 2. Discuss the features on hip joint MRI in patients with neuropathic pain. 3. Use fMRI to examine whether there are differences in patients diagnosed as neuropathic pain, psychogenic pain, nociceptive pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Characteristic findings of hip joint MRI in patients with neuropathic pain 2.Characteristic findings of fMRI in patients with neuropathic pain
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Questionnaires (painDETECT, BSPOP, SDS, HADS) and hip joint MRI will be implemented. Based on the results of the questionnaire, fMRI is performed on patients with neuropathic pain, psychogenic pain or nociceptive pain. The effective implementation days are 2 to 3 days.
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with osteoarthritis of the hip
Key exclusion criteria	Patients who can not respond to questionnaires due to dementia, mental illness.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomonori Tetsunaga
Organization	Okayama University Hospital Orthopedic Surgery
Division name	Okayama University Hospital Orthopedic Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL	086-235-7273
Email	tomonori_t31@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Tomonori Tetsunaga
Organization	Okayama University Hospital Orthopedic Surgery
Division name	Okayama University Hospital Orthopedic Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL	086-235-7273
Homepage URL
Email	tomonori_t31@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital Orthopedic Surgery
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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
Address
Tel
Email

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 07 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	Preinitiation
Date of protocol fixation	2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 18 Day
Last modified on	2017 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031110

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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