UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058469 |
|---|---|
| Receipt number | R000066318 |
| Scientific Title | Examination of factors influencing chronic postsurgical pain after total knee arthroplasty |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/08 19:25:08 |
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Basic information
Public title
Examination of factors influencing chronic postsurgical pain after total knee arthroplasty
Acronym
Examination of factors influencing chronic postsurgical pain after total knee arthroplasty
Scientific Title
Examination of factors influencing chronic postsurgical pain after total knee arthroplasty
Scientific Title:Acronym
Examination of factors influencing chronic postsurgical pain after total knee arthroplasty
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Total Knee Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify factors influencing chronic postsurgical pain after Total Knee Arthroplasty.
Basic objectives2
Others
Basic objectives -Others
pathophysiology and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity
Fremantle Knee Awareness Questionnaire
Pain Catastrophizing Scale
Tampa Scale of Kinesiophobia
The Hospital Anxiety and Depression Scale
Western Ontario McMaster Universities Osteoarthritis Index
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee Osteoarthritis
After Total Knee Arthroplasty
Key exclusion criteria
Neurological Diseases
Postoperative nerve damage
Rheumatoid arthritis
Dementia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Atomi |
Organization
Kyorin university
Division name
Department of Rehabilitation, Physical Therapy
Zip code
181-8612
Address
5-4-1 Shimorenjaku, Mitaka city, Tokyo, Japan
TEL
0422-47-8000
tatomi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinnsosuke |
| Middle name | |
| Last name | Hoshino |
Organization
Setagaya Orthopaedic Clinic
Division name
Rehabilitation
Zip code
157-0062
Address
6-36-6 Minamikarasuyama, Setagaya ward, Tokyo, Japan
TEL
0359318756
Homepage URL
hoshino@setagaya-joint.clinic
Sponsor or person
Institute
Setagaya Orthopaedic Clinic
Institute
Department
Personal name
Funding Source
Organization
NO
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
Kyorin University
Address
5-4-1 Shimorenjaku, Mitaka city, Tokyo, Japan
Tel
0422-47-8000
tatomi@ks.kyorin-u.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
世田谷人工関節・脊椎クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 15 | 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
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | 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
Questionnaires are evaluated preoperatively and at 1.5, 3, and 6 months postoperatively.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066318
