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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029553
Receipt No. 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

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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
Email 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
Email hmcyy0308@yahoo.co.jp

Sponsor
Institute Sonodakai Joint Replacement Center Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033768

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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