UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027384 |
|---|---|
| Receipt number | R000031110 |
| Scientific Title | Analysis of the pathology and mechanism of neuropathic pain in osteoarthritis of hip |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/05/18 15:35:30 |
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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
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
tomonori_t31@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital Orthopedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031110
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
