UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048548 |
|---|---|
| Receipt number | R000055316 |
| Scientific Title | Relationship between autonomic function and clinical symptoms such as pain and fatigue in patients with knee osteoarthritis. |
| Date of disclosure of the study information | 2022/08/02 |
| Last modified on | 2023/02/01 09:12:46 |
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Basic information
Public title
Relationship between autonomic function and clinical symptoms such as pain and fatigue in patients with knee osteoarthritis.
Acronym
Relationship between autonomic function and clinical symptoms in patients with knee OA
Scientific Title
Relationship between autonomic function and clinical symptoms such as pain and fatigue in patients with knee osteoarthritis.
Scientific Title:Acronym
Relationship between autonomic function and clinical symptoms in patients with knee OA
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To clarify the actual status of autonomic function in patients with knee osteoarthritis
2. To clarify the relationship between autonomic function and clinical symptoms in patients with knee osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Autonomic function using Photoplethysmography
Key secondary outcomes
Central Sensitization Inventory(CSI-9), Promis Fatigue(SF-8), Pain catastrophizing scale(PCS), Knee injury and Osteoarthritis Outcome Score (KOOS), physical activity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have been diagnosed with knee OA by their physician and are attending the hospital with knee pain as their main complaint.
Key exclusion criteria
1.Patients on the waiting list for knee joint replacement surgery
2.who has undergone artificial knee joint replacement surgery on the painful side of the knee
3.those with rheumatoid arthritis or other inflammatory joint diseases
4.other diseases or disorders other than osteoarthritis of the knee that cause knee pain or affect the function of the lower limb
5.those with fatigue resulting from cancer or internal disorders
6.Persons with cognitive impairment that prevents them from understanding the contents of the study.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yamano |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
H1371025@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yamano |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
Homepage URL
H1371025@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aoi Clinic
Tenjin Orthopaedics & Rheumatology
Oshima Orthopedic Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University Research ethics committee
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
Tel
+81-745-54-1601
soumu@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
| 2022 | Year | 08 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe autonomic function (sympathetic and parasympathetic), pain, fatigue, catastrophic thinking, and activity level
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055316
| Research Plan | |
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| 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 |
