UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of pain coping skills training in inpatients Undergone Total Knee Arthroplasty : Randomized Controlled Trial
Title of the study (Brief title)	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	Yosuke komori
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
Address	1-21-10, Hokima, Adachi, Tokyo
TEL	03-5831-1811
Email	hmcyy0308@yahoo.co.jp

Public contact
Name of contact person	Yosuke komori
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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