UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Acronym	The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Scientific Title	The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Scientific Title:Acronym	The effectiveness of the pre-operative rehabilitation prior to the total joint arthroplasty for postoperative pain-relief.
Region	Japan

Condition
Condition	Osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether pre-operative rehabilitation is effective in relieving postoperative pain for total joint arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain VAS NSAIDs, Opioid Laboratory data Range of motion of the joint Postop. 1,4,7,14,21,28,56,72days
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	A group that does not perform the above rehabilitation as before.
Interventions/Control_2	A group that loosens contracted muscles and joints, focusing on stretching and gymnastics of periarticular muscles before surgery (2-4wks)
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	30 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients scheduled to undergo total joint arthroplasty due to osteoarthritis
Key exclusion criteria	*a history of surgery on this joint in the past *Fracture cases
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Iwakiri
Organization	Shiraniwa Hospital
Division name	Orthopaedics
Zip code	6300136
Address	6-10-1 Shiraniwadai Ikoma-city, Nara
TEL	0743-70-0022
Email	kenpiecekenpiece@yahoo.co.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Iwakiri
Organization	Shiraniwa Hospital
Division name	Orthopaedics
Zip code	6300136
Address	6-10-1 Shiraniwadai Ikoma-city, nara
TEL	0743-70-0022
Homepage URL
Email	kenpiecekenpiece@yahoo.co.jp

Sponsor
Institute	Shiraniwa Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiraniwa Hospital
Address	6-10-1 Shiraniwadai Ikoma-city Nara
Tel	0743-70-0022
Email	kenpiecekenpiece@yahoo.co.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 09 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 02 Month 01 Day
Date of IRB	2021 Year 03 Month 01 Day
Anticipated trial start date	2021 Year 02 Month 15 Day
Last follow-up date	2022 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 02 Day
Last modified on	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049338