UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044538 |
|---|---|
| Receipt number | R000050883 |
| Scientific Title | Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2023/12/18 09:26:23 |
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Basic information
Public title
Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey
Acronym
Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey
Scientific Title
Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey
Scientific Title:Acronym
Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey
Region
| Japan |
Condition
Condition
Total knee arthroplasty (TKA)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this multicenter study is to investigate the incidence of CPSP in patients with TKA, and the factors involved.
Basic objectives2
Others
Basic objectives -Others
epidemiology, pathophysiology and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity
Tampa Scale of Kinesiophobia
Fremantle Knee Awareness Questionnaire
Western Ontario McMaster Universities Osteoarthritis Index
Central Sensitization Inventory
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
After TkA
Key exclusion criteria
severe chronic uncontrolled pain at a site other than the surgical knee before the surgery
a stroke or other central nervous system disorder
another recent surgery
rheumatoid arthritis
dementia
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Osaka Kawasaki Rehabilitation University
Division name
School of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka City, Osaka, Japan
TEL
072-446-6700
imair@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Osaka Kawasaki Rehabilitation University
Division name
School of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka City, Osaka, Japan
TEL
072-446-6700
Homepage URL
imair@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
NO
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Health and Welfare, Prefectural
University of Hiroshima,
Fukuoka Orthopaedic Hospital
Shion Hospital
Anshin hospital
Kashiba Asahigaoka Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Kawasaki Rehabilitation University
Address
158 Mizuma, Kaizuka City, Osaka, Japan
Tel
072-446-6700
imair@kawasakigakuen.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
| 2021 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
650
Results
The one-year incidence of chronic postsurgical pain (CPSP) stood at 9.5% among the postoperative cohort, comprising 56 patients. Age and BMI did not exhibit any statistically significant differences. females demonstrated a significantly higher propensity for developing CPSP. Furthermore, significant distinctions were observed in the trajectory slope of the pain experienced by the study participants.
Results date posted
| 2023 | Year | 12 | Month | 18 | Day |
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 | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this multicenter study is to investigate the incidence of CPSP in patients with TKA, and the factors involved.
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050883
