UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046741 |
|---|---|
| Receipt number | R000053327 |
| Scientific Title | Effects of a biopsychosocial model-based postoperative knee pain prevention program on chronic post-surgical pain after total knee arthroplasty. |
| Date of disclosure of the study information | 2022/04/15 |
| Last modified on | 2024/02/03 21:03:10 |
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Basic information
Public title
Effects of a biopsychosocial model-based postoperative knee pain prevention program on chronic post-surgical pain after total knee arthroplasty.
Acronym
Effects of a biopsychosocial model-based postoperative knee pain prevention program on chronic post-surgical pain after total knee arthroplasty.
Scientific Title
Effects of a biopsychosocial model-based postoperative knee pain prevention program on chronic post-surgical pain after total knee arthroplasty.
Scientific Title:Acronym
Effects of a biopsychosocial model-based postoperative knee pain prevention program on chronic post-surgical pain after total knee arthroplasty.
Region
| Japan |
Condition
Condition
Patients after total knee arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether a short-term intensive postoperative knee pain prevention program based on a biopsychosocial model can prevent prolonged knee pain after total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee Injury and Osteoarthritis Outcome Score(KOOS) pain Minimal Clinically Important Difference Achieved/not achieved
Key secondary outcomes
Age
Sex
Body Mass Index
Kellgren-Lawrence grade
Range of motion
KOOS symptoms/ ADL/ Sport and Recreation/ QOL
Pittsburgh Sleep Quality Index
Central Sensitization Inventory
Hospital Anxiety and Depression Scale
State-Trait Anxiety Inventory
Pain Catastrophizing Scale
Marital Status
Education
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Experimental group
Usual physical therapy + postoperative knee pain prevention program (60 minutes x 5 sessions)
Interventions/Control_2
Control group
Usual physical therapy only
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) Patients undergoing unilateral total knee arthroplasty for osteoarthritis
2) Patients who can walk independently with or without the use of assistive devices before and after total knee arthroplasty
Key exclusion criteria
1) Patients with rheumatoid arthritis
2) Patients with systemic lupus erythematosus
3) Patients with dementia
4) Patients with psychiatric disorders
5) Patients with neurological problems
6) Patients with complications after total knee arthroplasty
7) Patients after revision knee arthroplasty
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Nishimoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rehabilitation
Zip code
350-8550
Address
1981 Kamoda, Kawagoe city, Saitama
TEL
049-228-3529
j_nishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Nishimoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rehabilitation
Zip code
350-8550
Address
1981 Kamoda, Kawagoeshi, Saitama
TEL
049-228-3529
Homepage URL
j_nishi@saitama-med.ac.jp
Sponsor or person
Institute
Department of Rehabilitation, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Department of Rehabilitation, Fukuoka Rehabilitation Hospital
2) Department of Rehabilitation, Kurashiki Heisei Hospital
3) Faculty of Health and Social Services, Kanagawa University of Human Services
4) Graduate school of Humanities and Social Sciences, Hiroshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Research Support, Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda, Kawagoe city, Saitama
Tel
049-228-3902
smcrinri@saitama-med.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 | 04 | 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
121
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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053327
| 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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