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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000027384 |
Receipt No. | 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 |
Basic information | ||
Public title | Analysis of the pathology and mechanism of
neuropathic pain in osteoarthritis of hip |
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Acronym | Analysis of the pathology and mechanism of
neuropathic pain in osteoarthritis of hip |
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Scientific Title | Analysis of the pathology and mechanism of
neuropathic pain in osteoarthritis of hip |
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Scientific Title:Acronym | Analysis of the pathology and mechanism of
neuropathic pain in osteoarthritis of hip |
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Region |
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Condition | ||
Condition | osteoarthritis of the hip | |
Classification by specialty |
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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 |
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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. |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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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 |
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Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |