UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029553 |
|---|---|
| Receipt number | R000033768 |
| Scientific Title | Effectiveness of pain coping skills training in inpatients Undergone Total Knee Arthroplasty : Randomized Controlled Trial |
| Date of disclosure of the study information | 2017/10/14 |
| Last modified on | 2018/03/10 18:06:19 |
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Basic information
Public title
Effectiveness of pain coping skills training in inpatients Undergone Total Knee Arthroplasty : Randomized Controlled Trial
Acronym
Effectiveness of pain coping skills training after Total Knee Arthroplasty
Scientific Title
Effectiveness of pain coping skills training in inpatients Undergone Total Knee Arthroplasty : Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of pain coping skills training after Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A mental function influences postoperative results of total knee arthroplasty (TKA). Pain coping skills training (PCST) is one of the effective method to improve a mental function. However, there have been no reports concerning effects of PCST by physical therapist in patients after TKA. The purpose of this study is to clarify effectiveness of PCST after TKA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version Pain Catastrophizing scale
Key secondary outcomes
Japanese version Western Ontario and McMaster Universities Osteoarthritis Index
Japanese version Self-efficacy for rehabilitation outcome scale
Timed Up and Go test
Numeric Rating Scale
Knee extension torque
Knee range of motion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
pain coping skills training (Educational, Cognitive-behavioral therapy, Monitoring)
3 weeks, 6 times per week, 5 minutes per day
Standard exercises (Range of motion exercise, muscle strengthening, balance, ADL training)
3 weeks, 6 times per week, 90-120 minutes per day
Interventions/Control_2
Standard exercises (Range of motion exercise, muscle strengthening, balance, ADL training)
3 weeks, 6 times per week, 90-120 minutes per day
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis
Primary surgery
PCL retaining type implant
unilateral or bilateral surgery
Key exclusion criteria
Mental disease
Severe cardiovascular or nervous system disease
Musculoskeletal disorder
Cognitive disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke komori |
Organization
Sonodakai Joint Replacement Center Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-21-10, Hokima, Adachi, Tokyo
TEL
03-5831-1811
hmcyy0308@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke komori |
Organization
Sonodakai Joint Replacement Center Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-21-10, Hokima, Adachi, Tokyo
TEL
03-5831-1811
Homepage URL
hmcyy0308@yahoo.co.jp
Sponsor or person
Institute
Sonodakai Joint Replacement Center Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 10 | Month | 14 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033768
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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