UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051711 |
|---|---|
| Receipt number | R000059020 |
| Scientific Title | Influence of embodiment in Neuropathic Pain and Nociplastic Pain in Patients with Knee Disorders |
| Date of disclosure of the study information | 2023/07/25 |
| Last modified on | 2024/09/15 14:37:14 |
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Basic information
Public title
Embodiment in neuropathic pain and nociplastic pain
Acronym
Embodiment in neuropathic pain and nociplastic pain
Scientific Title
Influence of embodiment in Neuropathic Pain and Nociplastic Pain in Patients with Knee Disorders
Scientific Title:Acronym
Influence of embodiment in Neuropathic Pain and Nociplastic Pain in Patients with Knee Disorders
Region
| Japan |
Condition
Condition
Musculoskeletal disorders in knee joint
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying Embodiment Disorders in Neuropathic and Nociplastic Pain
Basic objectives2
Others
Basic objectives -Others
Elucidating the Mechanisms of Pain
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
central sensitization inventory-9 (CSI-9)
painDETECT questionnaire (PDQ)
Fremantle Knee Awareness Questionnaire (FreKAQ)
Key secondary outcomes
pain catastrophizing scale short form (PCS-short)
knee injury and osteoarthritis outcome score (KOOS)
numeric pain rating scale (NRS)
sense of body ownership and sense of agency: 7-point Likert scale
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with knee disease who visited our outpatient orthopedics and rehabilitation department
Key exclusion criteria
Patients with dementia, psychiatric or central nervous system disorders, and other patients who have difficulty in answering the questionnaire are excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Tanaka |
Organization
Kio University
Division name
Graduate school of health sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun
TEL
0745541601
f3983386@kio.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Tanaka |
Organization
Kio University
Division name
Graduate school of health sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun
TEL
0745541601
Homepage URL
f3983386@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun
Tel
0745541601
f3983386@kio.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
| 2023 | Year | 07 | Month | 25 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2023 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059020
